tag:blogger.com,1999:blog-37686951491523545922024-03-05T15:32:18.340-08:00eCTD Regulatory Submissions NetworkeCTD Regulatory Submissions Network Blog providing status updates and discuss on current regulatory trends including eCTD Submissions and best practices in the development and delivery of global dossiers.your comments,feedback and discussion help for all.Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.comBlogger468125tag:blogger.com,1999:blog-3768695149152354592.post-21056151913051921112013-06-24T09:11:00.002-07:002013-06-24T09:11:11.292-07:00Health Canada to Use US FDA’s Electronic Submission Gateway (ESG) for eCTD Submissions<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="text-align: justify;">
<span style="font-family: "Arial","sans-serif";">Very soon Pharmaceutical
organization able to submit/transfer their eCTD Submissions to Health Canada
through the US Food and Drug Administration’s gateway. Health Canada is
collaborating with its U.S. regulatory counterparts to reduce regulatory burden
for health products, and to move closer to an automated environment for the
exchange, review and management of information supporting the health product
review process.<o:p></o:p></span></div>
<div style="text-align: justify;">
</div>
<div class="MsoNormal" style="margin: 0in 0in 10pt; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; text-align: justify;">
<span style="font-family: "Arial","sans-serif";">One
initiative in this collaboration is the U.S. Food and Drug Administration’s
(FDA) – Health Canada Common Electronic Submission Gateway project, will enable
industry to submit health product submissions online for approval to Health
Canada, in the same way they do in the U.S.<o:p></o:p></span></div>
<div style="text-align: justify;">
<span style="font-family: "Arial","sans-serif";">Michael
Fauntleroy, Program Manager of FDA’s Electronic Submissions Gateway, noted
during a presentation for the GDUFA Conference in Silver Spring, MD on 13<sup><span style="font-size: x-small;">th</span></sup>
June 2013 that the FDA and Health Canada are in negotiations for FDA to act as
a service provider to Health Canada to facilitate electronic submissions via
the ESG. Mr. Fauntleroy hoped that the production environment would be
available this fall. <o:p></o:p></span></div>
<div style="text-align: justify;">
</div>
<div class="MsoNormal" style="margin: 0in 0in 10pt; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; text-align: justify;">
<span style="font-family: "Arial","sans-serif";">Find link to
a <span style="color: black;">summary of the plan </span>and goals from a
Canadian government website.<o:p></o:p></span></div>
<b><span style="font-family: "Arial","sans-serif";"><a href="http://actionplan.gc.ca/en/page/rcc-ccr/common-electronic-submissions-gateway-esg-work-plan"><span style="color: blue;">http://actionplan.gc.ca/en/page/rcc-ccr/common-electronic-submissions-gateway-esg-work-plan</span></a><o:p></o:p></span></b><br />
</div>
Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-52892391919270360152013-06-21T00:29:00.001-07:002013-06-21T00:29:02.314-07:00New Swissmedic Technical Validation Form<div dir="ltr" style="text-align: left;" trbidi="on">
<span style="font-family: Calibri;">Swissmedic released a new technical validation form to use
for Swiss eCTDs submission<o:p></o:p></span><br />
<br />
<span style="font-family: Calibri;">For more information <o:p></o:p></span><br />
<br />
<div class="MsoNormal" style="margin: 0in 0in 10pt;">
<a href="http://www.swissmedic.ch/zulassungen/00933/00937/01399/index.html?lang=en"><span style="color: blue; font-family: Calibri;">http://www.swissmedic.ch/zulassungen/00933/00937/01399/index.html?lang=en</span></a><o:p></o:p></div>
</div>
Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-30653869902769213362013-06-20T03:20:00.002-07:002013-06-20T03:20:32.227-07:00EMA – Revised Implementation Guide for EU Module 1, eCTD/NeeS validation Criteria<div dir="ltr" style="text-align: left;" trbidi="on">
<br />
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span lang="EN" style="font-family: "Arial","sans-serif"; mso-ansi-language: EN;">EMA publishes revised Implementation Guide for EU Module
1 Specification (v2.0), EU eCTD Validation Criteria (v5.0) and EU NeeS
Validation Criteria (v4.0)<br />
<br />
You find further information and a link to the Implementation Guide on EMA’s
esubmission webpage at <br />
<br />
<a href="http://www.linkedin.com/redirect?url=http%3A%2F%2Fesubmission%2Eemea%2Eeuropa%2Eeu%2F&urlhash=Hi-B&_t=tracking_anet" target="blank"><span style="color: blue;">http://esubmission.emea.europa.eu/</span></a><br />
<br />
For more information on the EU Module 1 v2.0 follow the link below<br />
<br />
<a href="http://www.linkedin.com/redirect?url=http%3A%2F%2Fesubmission%2Eemea%2Eeuropa%2Eeu%2Feumodule1%2Findex%2Ehtm&urlhash=b8W3&_t=tracking_anet" target="blank"><span style="color: blue;">http://esubmission.emea.europa.eu/eumodule1/index.htm</span></a></span><span style="font-family: "Arial","sans-serif";"><o:p></o:p></span></div>
</div>
Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-37978819909707619072013-06-05T23:24:00.001-07:002013-06-05T23:24:15.763-07:00The eCTD Summit: Automated Review Increases Vulnerability to Rejection<div dir="ltr" style="text-align: left;" trbidi="on">
As evidenced by the FDAs impending mandate that drug and life science companies switch from paper to eCTD format, the Agency is serious about transitioning to electronic submissions.<br />
<br />
The FDA is on the verge of instituting a change that will fully automate the process for those in the industry already submitting in eCTD. This is all part of the refinement underway to prepare for the overwhelming amount of electronic submissions expected as the mandate takes effect.<br />
With the human element gone from the process, there is no flexibility, no margin for error.<br />
<br />
The Agency recently updated to <a href="http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm163181.htm">eCTD Validation Criteria Version 2.2</a>, giving them the capability to accept or reject a submission on technical merit without the possibility of human intervention.<br />
Currently, a submission is loaded onto the Agency server and run through validation software. Error reports are then generated, and subsequently reviewed for legitimacy by a member of the FDA team.<br />
<br />
For more information <br />
<br />
<a href="http://theectdsummit.com/?p=2336">http://theectdsummit.com/?p=2336</a></div>
Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-32691443626296490072013-06-05T23:19:00.004-07:002013-06-05T23:19:44.244-07:00CH eCTD Module 1 specification 1.2 released by Swissmedic <div dir="ltr" style="text-align: left;" trbidi="on">
<div class="bodytext">
Swissmedic has released the new version 1.2 of the Swiss
Module 1 eCTD specification. The full set of documents released in this context
comprises</div>
<br />
<ul>
<li>eCTD CH Module 1 specification 1.2 ("<a class="external-link-new-window" href="http://www.swissmedic.ch/zulassungen/00933/00937/01171/index.html?lang=en&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1ad1IZn4Z2qZpnO2Yuq2Z6gpJCDd353gWym162epYbg2c_JjKbNoKSn6A--&.pdf" target="_blank" title="Opens external link in new window">clean</a>" version and "<a class="external-link-new-window" href="http://www.swissmedic.ch/zulassungen/00933/00937/01171/index.html?lang=en&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1ad1IZn4Z2qZpnO2Yuq2Z6gpJCDd354fWym162epYbg2c_JjKbNoKSn6A--&.pdf" target="_blank" title="Opens external link in new window">track change</a>" version)<br />
<ul>
<li><a class="external-link-new-window" href="http://www.swissmedic.ch/zulassungen/00933/00937/01171/index.html?lang=en&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1ad1IZn4Z2qZpnO2Yuq2Z6gpJCDd354e2ym162epYbg2c_JjKbNoKSn6A--&.pdf" target="_blank" title="Opens external link in new window">Implementation guidance</a>
<li><a class="external-link-new-window" href="http://www.swissmedic.ch/zulassungen/00933/00937/01171/index.html?lang=en&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1ad1IZn4Z2qZpnO2Yuq2Z6gpJCDd353gmym162epYbg2c_JjKbNoKSn6A--&.zip" target="_blank" title="Opens external link in new window">DTD</a>
<li><a class="external-link-new-window" href="http://www.swissmedic.ch/zulassungen/00933/00937/01171/index.html?lang=en&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1ad1IZn4Z2qZpnO2Yuq2Z6gpJCDd353g2ym162epYbg2c_JjKbNoKSn6A--&.zip" target="_blank" title="Opens external link in new window">Style sheet</a>
<li><a class="external-link-new-window" href="http://www.swissmedic.ch/zulassungen/00933/00937/01171/index.html?lang=en&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1ad1IZn4Z2qZpnO2Yuq2Z6gpJCDd353hGym162epYbg2c_JjKbNoKSn6A--&.zip" target="_blank" title="Opens external link in new window">Examples</a>
<li><a class="external-link-new-window" href="http://www.swissmedic.ch/zulassungen/00933/00937/01171/index.html?lang=en&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1ad1IZn4Z2qZpnO2Yuq2Z6gpJCDd354fGym162epYbg2c_JjKbNoKSn6A--&.pdf" target="_blank" title="Opens external link in new window">Checksum document</a></li>
</li>
</li>
</li>
</li>
</ul>
<li>Guidance for Industry on Providing Regulatory Information in eCTD Format
v1.4 ("<a class="external-link-new-window" href="http://www.swissmedic.ch/zulassungen/00933/00937/01171/index.html?lang=de&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1acy4Zn4Z2qZpnO2Yuq2Z6gpJCDd354gWym162epYbg2c_JjKbNoKSn6A--&.pdf" target="_blank" title="Opens external link in new window">clean</a>" version and "<a class="external-link-new-window" href="http://www.swissmedic.ch/zulassungen/00933/00937/01171/index.html?lang=de&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1acy4Zn4Z2qZpnO2Yuq2Z6gpJCDd354gmym162epYbg2c_JjKbNoKSn6A--&.pdf" target="_blank" title="Opens external link in new window">track change</a>" version)
<li>Q&A v1.6 ("<a class="external-link-new-window" href="http://www.swissmedic.ch/zulassungen/00933/00937/01171/index.html?lang=de&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1acy4Zn4Z2qZpnO2Yuq2Z6gpJCDd353f2ym162epYbg2c_JjKbNoKSn6A--&.pdf" target="_blank" title="Opens external link in new window">clean</a>" version and "<a class="external-link-new-window" href="http://www.swissmedic.ch/zulassungen/00933/00937/01171/index.html?lang=de&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1acy4Zn4Z2qZpnO2Yuq2Z6gpJCDd354gmym162epYbg2c_JjKbNoKSn6A--&.pdf" target="_blank" title="Opens external link in new window">track change</a>" version)
<li><a class="external-link-new-window" href="http://www.swissmedic.ch/zulassungen/00933/00937/01171/index.html?lang=de&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1acy4Zn4Z2qZpnO2Yuq2Z6gpJCDd354fmym162epYbg2c_JjKbNoKSn6A--&.xls" target="_blank" title="Opens external link in new window">Validation criteria v1.2 </a>
<li><a class="external-link-new-window" href="http://www.swissmedic.ch/zulassungen/00933/00937/01171/index.html?lang=de&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1acy4Zn4Z2qZpnO2Yuq2Z6gpJCDd354gGym162epYbg2c_JjKbNoKSn6A--&.xls" target="_blank" title="Opens external link in new window">Release notes</a> for the new validation criteria v1.2</li>
</li>
</li>
</li>
</li>
</ul>
<br />
<div class="bodytext">
<b>Implementation schedule:</b><br />The eCTD specification 1.2
will be implemented on July 01, 2013 and can be used by applicants from that
point onwards. The current version 1.1 will still be valid during a transition
period until December 31, 2013 . <b>From January 01, 2014 the usage of the new
CH Module 1 specification 1.2 will be mandatory for eCTD submissions to
Swissmedic</b>. <i>Note that eCTDs that have switched to the new version 1.2
during the transition period cannot be switched back to version 1.1.</i> </div>
<br />
<div class="bodytext">
<b>Guidance for Industry:</b><br />The Guidance version 1.4
contains only very limited modifications compared to the last version. The
change introduced considers the alignment of the new eCTD validation criteria
for Switzerland with the existing EU eCTD validation criteria (see below).
Details are obtainable from the "track change" version. </div>
<br />
<div class="bodytext">
<b>Q&A:</b><br />Also the Q&A have been modified in a
rather moderate fashion. Some Q&A have been updated due to the alignment of
the Swiss eCTD validation criteria with the current EU eCTD validation criteria
(3-3-2, 5-4 updated, 5-12 deleted). New dedicated eCTD subsections for some
forms have been introduced in section 1.2.2. Corresponding Q&As 3-3-5,
3-3-6, and 6-9 have been updated accordingly. </div>
<br />
<div class="bodytext">
A major update of the eCTD Module 1 specification 1.2 concerns
the Swiss Administrative Metadata in Module 1 ("envelope"). Among the changes,
the envelope element "application" is now repeatable. The corresponding Q&A
5-5 has been updated. See "track change" version of the Q&A for details.
</div>
<br />
<div class="bodytext">
<b></b><b></b><b>eCTD Validation Criteria</b>:<br />The new
Swiss eCTD Module 1 validation criteria have been aligned with the current EU
eCTD Module 1 validation criteria. As a major consequence the previous
classification of "A", "B", and "C" validation errors has been changed to
"Pass/Fail" criteria (P/F) and "Best Practice Guidance" (BPG) criteria. Details
can be obtained from the release notes. <b><br /></b></div>
<br />
<div class="bodytext">
<b>Swiss </b><b>eCTD Module 1 specification 1.2</b><b>:</b>
</div>
<br />
<div class="bodytext">
Numerous changes have been introduced, the key changes
are:</div>
<br />
<ul>
<li>File formats: .docx Word 2007 file formats are allowed now; the requirement
for additional MS Word formatted files for Module 2 documents have been removed.
<li>Table 1 detailing the possible switch to a subfolder "common" for a Module 1
with a 2<sup>nd</sup> galenic form branch for certain documents and the
corresponding allowed life cycle operation attributes have been updated
completely.
<li>Clarification regarding country codes for United Kingdom ("uk" allowed),
Greece ("el" allowed) and EU Centralized ("ema" or "emea" allowed) has been
introduced
<li>An additional row including the "Directory" name has been introduced on file
level in Table 4 detailing the directory / file structure for a Swiss Module 1.
Previously this information was covered by the "File" information.
<li>Additional directory / file names have been specified for some forms. This
resulted in new subsections 1.2.2.21 - 1.2.2.24.
<li>Appendix 2 with the "Envelope Element Description" has been largely
updated</li>
</li>
</li>
</li>
</li>
</li>
</ul>
For More information <br />
<br />
<a href="http://www.swissmedic.ch/zulassungen/00933/00937/index.html?lang=en">http://www.swissmedic.ch/zulassungen/00933/00937/index.html?lang=en</a></div>
Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-38251906081184048992013-06-05T23:02:00.004-07:002013-06-05T23:02:54.477-07:00EMA: Implementation guide for EU Module 1 Specification, version 2.0 released <div dir="ltr" style="text-align: left;" trbidi="on">
<div class="bodytext">
The Implementation guide for EU Module 1 Specification,
version 2.0 and EU eCTD Validation Criteria, version 5.0 and EU NeeS Validation
Criteria, version 4.0 has been published by the EU Telematics Implementation
Group - electronic submissions (TIGes). </div>
<br />
<div class="bodytext">
According to this implementation guide the <b>new EU
Validation Criteria</b> for eCTD and NeeS will come <b>into force on 01
September 2013 </b>and will be used for the technical validation for all
incoming electronic submissions by National Regulatory Agencies and the EMA. As
a consequence, the corresponding earlier versions of the EU Validation Criteria
will be withdrawn on 31 August 2013. </div>
<br />
<div class="bodytext">
Regarding the <b>new EU Module 1</b> that has been published
in 01 March 2013 a <b>transition period for </b>will be established: </div>
<br />
<ol>
<li>Starting from 01 July 2013 applicants can submit either eCTDs compliant with
EU Module v. 1.4.1 (applying eCTD validation criteria 4.1) <b>or</b> EU Module
v. 2.0 (applying eCTD validation criteria 5.0)
<li>From 01 September 2013 only eCTDs compliant with EU Module 1 v. 2.0 will be
accepted.</li>
</li>
</ol>
<br />
<div class="bodytext">
For NeeS submission the timelines and transitional
arrangements are applicable likewise. For NeeS, EU validation criteria 4.0 must
be used from 01 September 2013 on. </div>
<br />
<div class="bodytext">
<b>Guidance on how to submit information relevant to
Croatia</b>: </div>
<br />
<div class="bodytext">
If there is a need to provide information relevant to Croatia
prior to 01 September 2013 and EU Module 1 v. 2.0 cannot be used, it is
acceptable to submit the corresponding information for Croatia in the
"<sequence>-workingdocuments" folder accompanying the eCTD. A respective
subfolder "hr" should be used. A corresponding note should be included in the
cover letter. This approach is also applicable for Centralized Procedures. </div>
<div class="bodytext">
</div>
<div class="bodytext">
For More Information </div>
<div class="bodytext">
</div>
<div class="bodytext">
<a href="http://esubmission.emea.europa.eu/index.htm">http://esubmission.emea.europa.eu/index.htm</a></div>
</div>
Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-31435233561053555822012-08-23T07:54:00.001-07:002012-08-23T07:54:26.944-07:00Meeting of Czech and Slovak colleagues have been devoted to the problem eCTD<div dir="ltr" style="text-align: left;" trbidi="on">
<span lang="EN" style="font-family: "Times New Roman","serif"; font-size: 12pt; mso-ansi-language: EN; mso-fareast-font-family: "Times New Roman";"><span style="font-family: Arial, Helvetica, sans-serif;">Representatives
of the Czech State Institute for Drug Control (SIDC) visited Slovakia in order
to learn more about the electronic processing of documents related to the
registration of medicines for human use. Documentation in eCTD format is to be
submitted Slovak state constitution by June 2012. <br />
<br />
The meeting of the two parties was held on 08.21.2012. Bratislava headquarters
of the State Institute for Drug Control visited five representatives SIDC. The
aim of the meeting was to inform the Czech colleagues with data processing
systems in Slovakia. <br />
<br />
To find more information please use the below mentioned weblink<br />
<br />
</span><a href="http://www.linkedin.com/redirect?url=http%3A%2F%2Ftranslate%2Egoogle%2Ecom%2Ftranslate%3Fhl%3Den%26sl%3Dsk%26u%3Dhttp%3A%2F%2Fwww%2Esukl%2Esk%2Fsk%2Fmedia%2Ftlacove-spravy%2Fstretnutie-ceskych-a-slovenskych-kolegov-bolo-venovane-problematike-ectd%253Fpage_id%253D3094%26prev%3D%2Fsearch%253Fq%253Dectd%252B-job%252B-jobs%252B-globalsubmit%252B-softwaretopic%252B-aspire%2526hl%253Den%2526sa%253DX%2526tbo%253D1%2526rlz%253D1T4ADRA_enUS493US493%2526biw%253D1536%2526bih%253D721%2526tbs%253Dqdr%3Ad%2526prmd%253Dimvnsl%26sa%3DX%26ei%3DlSo2ULXzEoLr6wGg7IDICA%26ved%3D0CGUQ7gEwBA&urlhash=yJn9&_t=tracking_anet" target="blank"><span style="color: blue;"><span style="font-family: Arial, Helvetica, sans-serif;"><strong>http://translate.google.com/translate?hl=en&sl=sk&u=http://www.sukl.sk/sk/media/tlacove-spravy/stretnutie-ceskych-a-slovenskych-kolegov-bolo-venovane-problematike-ectd%3Fpage_id%3D3094&prev=/search%3Fq%3Dectd%2B-job%2B-jobs%2B-globalsubmit%2B-softwaretopic%2B-aspire%26hl%3Den%26sa%3DX%26tbo%3D1%26rlz%3D1T4ADRA_enUS493US493%26biw%3D1536%26bih%3D721%26tbs%3Dqdr:d%26prmd%3Dimvnsl&sa=X&ei=lSo2ULXzEoLr6wGg7IDICA&ved=0CGUQ7gEwBA</strong></span></span></a><o:p></o:p></span><br />
</div>
Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-45515351357555769952012-08-22T11:29:00.004-07:002012-08-22T11:29:45.526-07:00Mission3: President Obama Signs PDUFA Reauthorization<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="text-align: justify;">
<span lang="EN" style="mso-ansi-language: EN;"><span style="font-family: Arial, Helvetica, sans-serif;">On July 9, 2012,
President Obama signed the reauthorization of the Prescription Drug User Fee
Act (PDUFA). Under the law, Starting October 1, the generic drug industry will
pay $299 million a year in user fees over the next five years, which will help
pay for more FDA staff to help clear a backlog of some 2,500 generic drug
applications and more inspections of manufacturers’ production plants.<br />
<br />
The resigning of the PDUFA was the fifth reauthorization. This is an achievement
for patients, industry and the FDA. The PDUFA program will make certain that
all Americans receive timely access to safe, effective, and affordable generic
drugs. PDUFA is considered a must-pass measure because the FDA has become
reliant on the money it generates. In 2010, more than $550 million in user fees
collected by the FDA covered 62% of the agency’s costs for drug reviews.<br />
<br />
To find more information please use the below mentioned weblink <br />
<br />
</span><a href="http://www.linkedin.com/redirect?url=http%3A%2F%2Fmission3%2Ecom%2Fcompany%2Fnewsletter%2F122&urlhash=QZYR&_t=tracking_anet" target="blank"><span style="color: blue; font-family: Arial, Helvetica, sans-serif;"><strong>http://mission3.com/company/newsletter/122</strong></span></a><o:p></o:p></span></div>
</div>
Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com1tag:blogger.com,1999:blog-3768695149152354592.post-56871148272510851302012-08-22T10:50:00.003-07:002012-08-22T10:50:06.961-07:00CSC: 2015 - the Mayans may have been off by three years – By Joel Finkle, Senior Strategist, Regulatory Services Delivery<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="text-align: justify;">
<span lang="EN" style="font-family: "Calibri","sans-serif"; font-size: 11pt; line-height: 115%; mso-ansi-language: EN; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-language: AR-SA; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin;"><span style="font-family: Arial, Helvetica, sans-serif;">Looking
at pending regulatory changes, I have to wonder if a lot of regulatory affairs
and operations are planning on retiring by 2014, because the following year
there’s a lot of changes coming:<br />
<br />
1) eCTD 4.0 (aka RPS) should be an approved ISO standard and there’s a good
shot of it being accepted by all ICH regions<br />
<br />
2) The IDMP ISO standard will be required for product registrations<br />
<br />
3) FDA will require all NDAs to be in eCTD format<br />
<br />
To find more information please use the below mentioned weblink <br />
<br />
</span><a href="http://www.linkedin.com/redirect?url=http%3A%2F%2Fwww%2Ecsc%2Ecom%2Fhealth_services%2Fblog%2F74101%2F88217-2015_the_mayans_may_have_been_off_by_three_years&urlhash=s6Wf&_t=tracking_anet" target="blank"><span style="color: blue; font-family: Arial, Helvetica, sans-serif;"><strong>http://www.csc.com/health_services/blog/74101/88217-2015_the_mayans_may_have_been_off_by_three_years</strong></span></a></span></div>
</div>
Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-86327214955195686242012-08-17T08:46:00.000-07:002012-08-17T08:46:05.697-07:00CSC: Fourth Time’s the Charm: eCTD 4.0 is coming!<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="text-align: justify;">
<span lang="EN" style="mso-ansi-language: EN;"><span style="font-family: Arial, Helvetica, sans-serif;">Some of you may
only now be getting used to the eCTD as it is, but while you’ve been busy
creating submissions, ICH and Health Level Seven (HL7) have been busily working
to replace it. eCTD 4.0 has just had a Draft Implementation Guide issued, which
should be posted to the ICH ESTRI website shortly, if it isn’t there already.<br />
<br />
Don’t panic, it’s still a couple years away from implementation (probably 2015
is the earliest you could think about submitting in 4.0 format), but we’ll
break it to you gently.<br />
<br />
<strong>Why can’t we “leaf” it alone?</strong><br />
<br />
eCTD 4.0 is the implementation of the Electronic Common Technical Document
using the RPS (Regulated Product Submissions) standard developed at HL7. RPS
came about originally as an FDA initiative to create a single submission
standard that can be used for all its divisions: not just eCTDs for drugs and
biologics, but veterinary, food additives, cosmetics, devices (and perhaps
tobacco).<br />
<br />
To find more information please use the below mentioned weblink <br />
<br />
</span><a href="http://www.linkedin.com/redirect?url=http%3A%2F%2Fwww%2Ecsc%2Ecom%2Fhealth_services%2Fblog%2F74101%2F87525-fourth_time_s_the_charm_ectd_4_0_is_coming&urlhash=ZbVv&_t=tracking_anet" target="blank"><span style="color: blue; font-family: Arial, Helvetica, sans-serif;"><strong>http://www.csc.com/health_services/blog/74101/87525-fourth_time_s_the_charm_ectd_4_0_is_coming</strong></span></a><o:p></o:p></span></div>
</div>
Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-86082501380631162882012-08-17T08:45:00.002-07:002012-08-17T08:45:15.770-07:00FDA releases final version 2.0 of the US eCTD Module 1 specification<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="text-align: justify;">
<span lang="EN" style="mso-ansi-language: EN;"><span style="font-family: Arial, Helvetica, sans-serif;">The U.S. Food and
Drug Administration (FDA) has released the final version 2.0 of the regional US
eCTD Module 1 specification files. <br />
<br />
The Module 1 eCTD specification files have been released earlier as draft
versions which were open for comments from stakeholders. Version 2 incorporates
several major updates to module 1 of the eCTD to "reflect regulatory
changes, to provide clarification of business rules for submission processing
and review, to refine the characterization of promotional marketing and advertising
material, and to facilitate automated processing" (quotation from FDA
website). <br />
<br />
To find more information please use the below mentioned weblink <br />
<br />
</span><a href="http://www.linkedin.com/redirect?url=http%3A%2F%2Fwww%2Eexalon%2Ecom%2Fectd-news%2Fnews-details%2Farticle%2Ffda-releases-final-version-20-of-the-us-ectd-module-1-specification%2Ehtml&urlhash=bI1h&_t=tracking_anet" target="blank"><span style="color: blue; font-family: Arial, Helvetica, sans-serif;"><strong>http://www.exalon.com/ectd-news/news-details/article/fda-releases-final-version-20-of-the-us-ectd-module-1-specification.html</strong></span></a><o:p></o:p></span></div>
</div>
Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-65240310993323189152012-08-17T08:44:00.002-07:002012-08-17T08:44:22.968-07:00Exalon: EU: New draft eCTD guidance for ASMFs released<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="text-align: justify;">
<span lang="EN" style="mso-ansi-language: EN;"><span style="font-family: Arial, Helvetica, sans-serif;">A new Guidance
detailing practical and technical points related to the submission and handling
of an ASMF (Active Substance Master File - previously also known as European
Drug Master File, EDMF) in eCTD format has been drafted by a joint working
group comprising representatives from EU Regulatory Authorities, the EMA,
industry, EDQM and ASMF holders. <br />
<br />
The Guidance is available as final draft version and comments from stakeholders
are actively sought. The objective is to update the guidance as necessary in
July 2010. Comments should be sent to esubmission@mpa.se. <br />
<br />
To find more information please use the below mentioned web link <br />
<br />
</span><a href="http://www.linkedin.com/redirect?url=http%3A%2F%2Fwww%2Eexalon%2Ecom%2Findex%2Ephp%3Fid%3D69%26tx_ttnews%255Bpointer%255D%3D3%26tx_ttnews%255Btt_news%255D%3D128%26tx_ttnews%255BbackPid%255D%3D68%26cHash%3Df8e67301d1&urlhash=Revs&_t=tracking_anet" target="blank"><span style="color: blue; font-family: Arial, Helvetica, sans-serif;"><strong>http://www.exalon.com/index.php?id=69&tx_ttnews%5Bpointer%5D=3&tx_ttnews%5Btt_news%5D=128&tx_ttnews%5BbackPid%5D=68&cHash=f8e67301d1</strong></span></a><o:p></o:p></span></div>
</div>
Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-46609336529739349292012-08-17T08:43:00.002-07:002012-08-17T08:43:24.275-07:00Exalon: EMA releases another update of the CHMP dossier requirements<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="text-align: justify;">
<span lang="EN" style="mso-ansi-language: EN;"><span style="font-family: Arial, Helvetica, sans-serif;">The European
Medicines Agency (EMA) has released another update of the "Dossier
requirements for Members of the Committee for medicinal products for human use
(CHMP)". In this most recent version, dated 14 August 2012 the following
minor changes were incorporated:<br />
<br />
•The representative for Czech Republic was changed to "Awaiting
Nomination"<br />
<br />
•The address for the representative of Iceland (Kolbeinn Gudmundsson) has been
corrected <br />
<br />
•The representative for Portugal did change from Beatriz Silva Lima to Bruno
Sepodes. The corresponding address was updated. <br />
<br />
•The representative for Slovenia was changed to "Awaiting Nomination"<br />
<br />
There are no changes regarding the requirements of CD-ROM copies for the CHMP
members. <br />
<br />
To find more information please use the below mentioned weblink<br />
<br /><strong>
</strong></span><a href="http://www.linkedin.com/redirect?url=http%3A%2F%2Fwww%2Eexalon%2Ecom%2Fectd-news%2Fnews-details%2Farticle%2Fema-releases-another-update-of-the-chmp-dossier-requirements%2Ehtml&urlhash=UXmi&_t=tracking_anet" target="blank"><span style="color: blue; font-family: Arial, Helvetica, sans-serif;"><strong>http://www.exalon.com/ectd-news/news-details/article/ema-releases-another-update-of-the-chmp-dossier-requirements.html</strong></span></a><o:p></o:p></span></div>
</div>
Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-87161691404744898652012-08-13T07:50:00.004-07:002012-08-13T07:50:46.431-07:00FDA: New Study Data Exchange Format – Requesting Comments & Holding Meeting <div dir="ltr" style="text-align: left;" trbidi="on">
<br />
<div style="text-align: justify;">
<span style="color: black; font-size: 11pt; mso-themecolor: text1;"><span style="font-family: Arial, Helvetica, sans-serif;">The FDA is
requesting comments from industry and the public on the development of
standards for study data exchange standards.<o:p></o:p></span></span></div>
<div style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">
</span></div>
<div style="text-align: justify;">
<span style="color: black; font-size: 11pt; mso-themecolor: text1;"><span style="font-family: Arial, Helvetica, sans-serif;">In <em><span style="font-family: "Arial","sans-serif";">Federal Register</span></em> notice,
FDA mentioned that they are </span><span style="color: black; mso-themecolor: text1;"><span style="font-family: Arial, Helvetica, sans-serif;">holding a
meeting to assess the suitability of the current study data exchange format</span></span><span style="font-family: Arial, Helvetica, sans-serif;">,
the ASCII-based SAS Transport (XPORT) version 5 used by its drugs, biologics and
devices regulatory centers and also mentioned that this meeting will be geared
toward understanding the costs and benefits of moving to a new study data
exchange standard and determining the next steps to formulate a plan of action.<o:p></o:p></span></span></div>
<div style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">
</span></div>
<div class="MsoNormal" style="margin: 0in 0in 10pt; text-align: justify;">
<span style="color: black; font-family: "Arial","sans-serif"; mso-themecolor: text1;"><span style="font-family: Arial, Helvetica, sans-serif;">To fine more information please use the below mentioned
weblink <o:p></o:p></span></span></div>
<div style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">
</span></div>
<div class="MsoNormal" style="margin: 0in 0in 10pt; text-align: justify;">
<a href="https://www.federalregister.gov/articles/2012/08/14/2012-19748/solutions-for-study-data-exchange-standards-meeting-request-for-comments-regulatory-new-drug-review"><span style="color: #009bc9; font-family: Arial, Helvetica, sans-serif;"><strong>https://www.federalregister.gov/articles/2012/08/14/2012-19748/solutions-for-study-data-exchange-standards-meeting-request-for-comments-regulatory-new-drug-review</strong></span></a><o:p></o:p></div>
</div>
Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-85917481556237954042012-08-10T18:11:00.005-07:002012-08-10T18:11:38.705-07:00Breaking Regulatory Update for Life Science Firms – UFA Requirements for eCTDs<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">On July 9, President Obama signed the FDA Innovation and Safety Act (S3187) which reauthorized PDFUA and MDUFA, implemented the Generic Drug User Fee Act and the Biosimilar User Fee Act. All of these updated regulations have new, far-reaching consequences for all life sciences firms in the United States. Tune into our new webinar on Sept. 12 to learn the details!<br /><br /><strong>Details:</strong><br /><br />Together these new regulations are called the “UFAs.” Key to PDUFA and GDUFA are mandates for electronic submission – very likely in the eCTD format. In additional MDUFA calls for mandatory Electronic Copy to replace one of the paper copies required for presubmissions and submissions to CDRH.<br /><br />FDASIA is effective October 1, 2012. Many sponsors inexperienced in the various electronic submission requirements of FDAISA will have great difficulty in meeting the mandates, timelines and quality requirements.</span></div>
<div style="text-align: justify;">
<br /></div>
<div style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">To find more information please use the below mentioned weblink</span></div>
<div style="text-align: justify;">
<br /></div>
<div style="text-align: justify;">
<a href="http://www.expertbriefings.com/events/breaking-regulatory-update-for-life-science-firms-ufa-requirements-for-ectds-sept-12-2012-2-330-pm-edt-azevedo/"><span style="font-family: Arial, Helvetica, sans-serif;"><strong>http://www.expertbriefings.com/events/breaking-regulatory-update-for-life-science-firms-ufa-requirements-for-ectds-sept-12-2012-2-330-pm-edt-azevedo/</strong></span></a></div>
</div>Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-58007132477312693542012-08-10T18:08:00.002-07:002012-08-10T18:08:57.511-07:00Danish: Closer attention to guidelines on submission of electronic applications for marketing authorisations<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">Our guidelines on submission of electronic applications to the Danish Health
and Medicines Authority have been available on our website for some time, but we
wish to draw attention to them once again. </span></div>
<div style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">
</span></div>
<div style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">As we have received a number of incorrect submissions, we kindly request
applicants to read through the guidelines once more: </span></div>
<div style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">
</span></div>
<div sizcache="23" sizset="66" style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">Guidelines
on submission of electronic applications </span></div>
<div style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">
</span></div>
<div style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">Briefly stated, we remind applicants that we distinguish between
"applications" and "submissions" in that one application consists of one or
several submissions.</span></div>
<div style="text-align: justify;">
<br /></div>
<div style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">To find more information use the below mentioned weblink</span></div>
<div style="text-align: justify;">
<br /></div>
<div style="text-align: justify;">
<a href="http://laegemiddelstyrelsen.dk/en/topics/authorisation-and-supervision/licensing-of-medicines/news/closer-attention-to-guidelines-on-submis--orisations"><span style="font-family: Arial, Helvetica, sans-serif;"><strong>http://laegemiddelstyrelsen.dk/en/topics/authorisation-and-supervision/licensing-of-medicines/news/closer-attention-to-guidelines-on-submis--orisations</strong></span></a></div>
</div>Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-78205076981160425212012-08-03T08:10:00.005-07:002012-08-03T08:10:51.509-07:00Accenture acquiring Octagon Research Solutions<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;"><span style="color: black;"><span style="color: #778888; font-family: "Arial","sans-serif"; mso-fareast-font-family: "Times New Roman";"><span style="color: black;">Accenture (NYSE: ACN)
has entered into an agreement to acquire Octagon Research Solutions, Inc., a
provider of clinical and regulatory information management solutions and
software for the pharmaceutical industry. Terms of the transaction were not
disclosed.</span> </span><span style="color: #778888; font-family: "Arial","sans-serif"; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></span></span></div>
<div style="text-align: justify;">
<span style="color: black; font-family: Arial, Helvetica, sans-serif;">
</span></div>
<div class="MsoNormal" style="line-height: 12pt; margin: 0in 0in 0pt; text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;"><span style="color: black;"><span style="color: #778888; font-family: "Arial","sans-serif"; mso-fareast-font-family: "Times New Roman";">The acquisition will
enhance Accenture's ability to help its pharmaceutical clients achieve more
efficient global regulatory submissions that will enable them to get medicines
to market more quickly, safely and at a lower cost. Accenture's capabilities
will be expanded to include comprehensive clinical and regulatory services -
from clinical data collection to regulatory submissions management. Accenture
also will extend its business process outsourcing (BPO) services portfolio
targeting the pharmaceutical industry.</span><span style="color: #778888; font-family: "Arial","sans-serif"; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></span></span></div>
<div style="text-align: justify;">
<span style="color: black; font-family: Arial, Helvetica, sans-serif;">
</span></div>
<div class="MsoNormal" style="line-height: 12pt; margin: 0in 0in 7.5pt; text-align: justify;">
<span style="color: #778888; font-family: "Arial","sans-serif"; mso-fareast-font-family: "Times New Roman";"><span style="color: black; font-family: Arial, Helvetica, sans-serif;">Octagon's 380-member staff has deep experience
in clinical data services and regulatory submissions, with 400 original
applications completed, and the company is the fifth largest user of the U.S.
Food and Drug Administration's (FDA) electronic submission gateway. Octagon is
a recognized provider for the FDA in establishing clinical data conversion and
training standards and has deep knowledge of regulatory affairs combined with
well established relationships developed by partnering with regulatory
authorities. Octagon will be fully integrated into Accenture's Life Sciences
industry group.</span></span></div>
<div class="MsoNormal" style="line-height: 12pt; margin: 0in 0in 7.5pt; text-align: justify;">
<br /></div>
<div class="MsoNormal" style="line-height: 12pt; margin: 0in 0in 7.5pt; text-align: justify;">
<span style="color: black;"><span style="color: #778888; font-family: "Arial","sans-serif"; mso-fareast-font-family: "Times New Roman";"><span style="color: black;">To find more information please use the below mentioned web link</span> </span></span></div>
<span style="font-family: "Calibri","sans-serif"; line-height: 115%; mso-ansi-language: EN-US; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-language: AR-SA; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin;"><a href="http://newsroom.accenture.com/news/accenture-to-expand-clinical-and-regulatory-information-management-services-and-software-capabilities-with-agreement-to-acquire-octagon-research-solutions.htm"><span style="color: #4f4f4f; font-family: Arial, Helvetica, sans-serif;"><strong>http://newsroom.accenture.com/news/accenture-to-expand-clinical-and-regulatory-information-management-services-and-software-capabilities-with-agreement-to-acquire-octagon-research-solutions.htm</strong></span></a></span></div>Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-59842171176904943632012-08-03T08:08:00.004-07:002012-08-03T08:08:33.859-07:00CSC: “As Advertised” - FDA Module 1 Continued – By Joel Finkle, Senior Strategist, Regulatory Services Delivery<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="text-align: justify;">
<span lang="EN" style="color: #747678; font-family: "Arial","sans-serif"; mso-ansi-language: EN;"><span style="color: black; font-family: Arial, Helvetica, sans-serif;">Picking up where we
left off </span><a href="http://www.csc.com/health_services/blog/74101/86381-what_was_the_part_in_the_middle_fda_s_module_1_v2_applications_submissions_and_sequences" target="_blank"><span style="color: black; font-family: Arial, Helvetica, sans-serif;">last time on the FDA Module 1 changes</span></a><span style="font-family: Arial, Helvetica, sans-serif;"><span style="color: black;"> the other big news is
that the Office of Prescription Drug Promotion (OPDP), formerly Division of
Drug Marketing, Advertising and Communications – DDMAC, is finally getting with
the 21st century: promotional and marketing materials can now be electronically
submitted in the eCTD. Currently, much of the promotional materials can be sent
electronically, but only on hard media such as CDs, not through the gateway,
and not in eCTD format.<o:p></o:p></span></span></span></div>
<div style="text-align: justify;">
<span style="color: black; font-family: Arial, Helvetica, sans-serif;">
</span></div>
<div style="line-height: 18pt; text-align: justify;">
<strong><span lang="EN" style="color: #747678; font-family: "Arial","sans-serif"; mso-ansi-language: EN;"><span style="font-family: Arial, Helvetica, sans-serif;"><span style="color: black;">Promotional
Materials</span></span></span></strong></div>
<div style="line-height: 18pt; text-align: justify;">
<strong><span lang="EN" style="color: #747678; font-family: "Arial","sans-serif"; mso-ansi-language: EN;"><span style="color: black;"></span></span></strong><b><span lang="EN" style="color: #747678; font-family: "Arial","sans-serif"; mso-ansi-language: EN;"><br /><span style="color: black; font-family: Arial, Helvetica, sans-serif;">
</span></span></b><span lang="EN" style="color: #747678; font-family: "Arial","sans-serif"; mso-ansi-language: EN;"><span style="font-family: Arial, Helvetica, sans-serif;"><span style="color: black;">Section 1.15 of the US NDA covers
Promotional Materials. There’s a list of subcategories in 1.15.1 related to
correspondence, and 1.15.2.1 is the promotional material itself. Rather than
creating dozens of XML elements in the DTD for these categories, FDA has added
some new metadata. There is a promotional-material-audience-type containing a
code indicating “Consumer” or “Professional” for all of 1.15, and
promotional-materials-doc-type and promotional-material-type for 1.15.2. The
doc-type indicates the type of submission, e.g. “Promotional 2253” or
“Presubmission Accelerated Launch” no more 3-letter codes on the 2253 form. The
material-type indicates the type of material (website, print ad, sales-aid,
etc.) and that XML element has sub-sections to indicate the Clean, Annotated,
Annotated Labeling or Annotated References versions of those materials.<o:p></o:p></span></span></span></div>
<div style="text-align: justify;">
<span style="color: black; font-family: Arial, Helvetica, sans-serif;">
</span></div>
<div class="MsoNormal" style="margin: 0in 0in 10pt; text-align: justify;">
<span lang="EN" style="mso-ansi-language: EN;"><o:p><span style="color: black; font-family: Arial, Helvetica, sans-serif;"> </span></o:p></span><span lang="EN" style="mso-ansi-language: EN;"><span style="font-family: Calibri;"><span style="color: black; font-family: Arial, Helvetica, sans-serif;">To find more
information use the below mentioned weblink</span> </span></span></div>
<div class="MsoNormal" style="margin: 0in 0in 10pt; text-align: justify;">
<span lang="EN" style="font-family: "Calibri","sans-serif"; font-size: 11pt; line-height: 115%; mso-ansi-language: EN; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-language: AR-SA; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin;"><a href="http://www.csc.com/health_services/blog/74101/87030-as_advertised_fda_module_1_continued"><span style="color: #4f4f4f; font-family: Arial, Helvetica, sans-serif;"><strong>http://www.csc.com/health_services/blog/74101/87030-as_advertised_fda_module_1_continued</strong></span></a></span></div>
</div>Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-74689307074340989372012-07-31T09:00:00.006-07:002012-07-31T09:00:35.589-07:00FDA eSubmission: Transmission Specifications – Guidance Updated<div dir="ltr" style="text-align: left;" trbidi="on">
<span style="font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 11.5pt;">We can find clarification
that USB encryption is optional Rewording information regarding password protection
of data vs. USB drive</span><span style="font-family: "Times New Roman","serif"; font-size: 12pt; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></span><br />
<span style="font-family: Arial, Helvetica, sans-serif;">
</span><br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 10pt; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: "Times New Roman","serif"; font-size: 12pt; mso-fareast-font-family: "Times New Roman";"><span style="font-family: Arial, Helvetica, sans-serif;">To find updated guidance use the
below mentioned weblink <o:p></o:p></span></span></div>
<span style="font-family: Arial, Helvetica, sans-serif;">
</span><br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 10pt; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: "Times New Roman","serif"; font-size: 12pt; mso-fareast-font-family: "Times New Roman";"><a href="http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163567.pdf"><span style="color: blue; font-family: Arial, Helvetica, sans-serif;"><strong>http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163567.pdf</strong></span></a><o:p></o:p></span></div>
</div>Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-58015025970277822712012-07-30T10:25:00.003-07:002012-07-30T10:25:42.061-07:00RAPS: EU Regulators Expand Electronic Submission Program, Recommend Wider Use<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<span style="font-size: small;">After a four-month pilot period, EU regulators are proposing to make
permanent a program that allows applicants and sponsors of marketing
authorization applications to submit their entire dossiers
electronically.</span></div>
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<br /></div>
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<span style="font-size: small;">The European Medicines Agency's (EMA) 27 July statement on continuing
the electronic application form (eAF) pilot program says the testing
phase was "successful," and use of the program will allow sponsors and
applicants to better control the quality and consistency of the data in
their submissions. </span></div>
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<span style="font-size: small;">Applicants will still be allowed to use paper-based forms, through
EMA said it is "recommending" the use of the electronic application
forms, which may be used to apply for initial authorizations, variations
and renewals.</span></div>
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<br /></div>
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<span style="font-size: small;">The <a href="http://www.raps.org/focus-online/news/news-article-view/article/1033/ema-launches-pilot-program-for-electronic-applications.aspx" target="_blank">pilot phase of the program</a>
was first launched on 12 March 2012 by EMA, which said at the time that
the program was a "key step forward in the Agency's drive towards the
use of electronic applications as standard, using the Electronic Common
Technical Document (eCTD) format."</span></div>
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<br /></div>
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<span style="font-size: small;">To find more information please use the below mentioned weblink</span></div>
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<br /></div>
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<a href="http://www.raps.org/focus-online/news/news-article-view/article/1992/eu-regulators-expand-electronic-submission-program-recommend-wider-use.aspx?goback=.gmp_137301.gde_137301_member_140164588"><span style="font-size: small;">http://www.raps.org/focus-online/news/news-article-view/article/1992/eu-regulators-expand-electronic-submission-program-recommend-wider-use.aspx?goback=.gmp_137301.gde_137301_member_140164588</span></a></div>
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<span style="font-size: small;"> </span></div>
</div>Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-85500895369796566312012-07-30T10:24:00.001-07:002012-07-30T10:24:05.949-07:00Exalon: CMDh releases updated guidance documents regarding submission of variations<div dir="ltr" style="text-align: left;" trbidi="on">
<div class="bodytext" style="font-family: Arial,Helvetica,sans-serif;">
<span style="font-size: small;">The Co-ordination Group for Mutual Recognition and
Decentralized Procedures - Human (CMDh) has released some updated
guidance regarding the submission of variations in accordance to
Commission Regulation (EC) 1234/2008. </span></div>
<div class="bodytext" style="font-family: Arial,Helvetica,sans-serif;">
<br /></div>
<div class="bodytext" style="font-family: Arial,Helvetica,sans-serif;">
<span style="font-size: small;">The update concerns the corresponding <b>Q/A list (document CMDh/132/2009)</b> which has been released as revision 13, dated June 2012 <span lang="EN-US" style="color: black;">(available as "<a class="external-link-new-window" href="http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_132_2009_Rev13-Clean_2012_06.pdf" target="_blank" title="Opens external link in new window">clean version</a>" and "<a class="external-link-new-window" href="http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_132_2009_Rev13-Tracked_2012_06.pdf" target="_blank" title="Opens external link in new window">track-change version</a>")</span>. Compared with revision 12, the update contains the following changes:</span></div>
<div class="bodytext" style="font-family: Arial,Helvetica,sans-serif;">
<br /></div>
<ul style="font-family: Arial,Helvetica,sans-serif;">
<li><span style="font-size: small;">New
Question 1.7 dealing with how changes in the SmPC/Labelling/PL should
be identified when submitted with an applicant`s response: If such
comments are made during the variation procedure a new version of the
SmPC/Labelling/PL including all revised wording clearly identified,
preferably using track-changes function should be provided. Note: It is
not acceptable if the highlighted texts only identify the changes made
in part of the variation procedure, e.g. since clock stop. Furthermore,
it should be clear "what changes originate from the initial submission
and what changes are proposed as a response to the received comments.
The highlighted final texts circulated by RMS to CMS at the end of
procedure should clearly identify all changes approved during the
procedure" </span></li>
<li><span style="font-size: small;">The response to Question 4.13 asking whether it is
allowed to submit different class labellings agreed by PhVWP/CMDh as a
grouped application has been transfered to the document "Examples for
acceptable and not acceptable groupings for MRP/DCP products" which has
been updated in parallel (see below) </span></li>
</ul>
<div class="bodytext" style="font-family: Arial,Helvetica,sans-serif;">
<br /></div>
<br /><div class="bodytext" style="font-family: Arial,Helvetica,sans-serif;">
<span style="font-size: small;">To find more information please use the below mentioned weblink </span></div>
<div class="bodytext" style="font-family: Arial,Helvetica,sans-serif;">
<span style="font-size: small;"><br /></span></div>
<div class="bodytext" style="font-family: Arial,Helvetica,sans-serif;">
<span style="font-size: small;"><a href="http://www.exalon.com/ectd-news/news-details/article/cmdh-releases-updated-guidance-documents-regarding-submission-of-variations.html">http://www.exalon.com/ectd-news/news-details/article/cmdh-releases-updated-guidance-documents-regarding-submission-of-variations.html</a></span></div>
<div class="bodytext" style="font-family: Arial,Helvetica,sans-serif;">
<br /></div>
<div class="bodytext" style="font-family: Arial,Helvetica,sans-serif;">
<span style="font-size: small;"> </span></div>
</div>Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-27629253757786528782012-07-30T05:20:00.001-07:002012-07-30T05:20:12.828-07:00EU validation criteria v4.1 (eCTD) & v3.0 (Nees) – Webinar Slides are available for Reference<div dir="ltr" style="text-align: left;" trbidi="on">
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<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif;">
<span style="font-size: small;"><span class="t102"><span style="line-height: 115%;">The TIGes Harmonization has conducted EU validation webinar on Friday 13
July 2012. </span></span></span></div>
<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif;">
<br /></div>
<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif; line-height: normal;">
<span style="font-size: small;"><span>The slides that were presented at
the Webinar are available for reference </span></span></div>
<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif; line-height: normal;">
<br /></div>
<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif;">
<b><span style="font-size: small;">Webinar Slides</span></b></div>
<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif;">
<br /></div>
<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif;">
<span style="font-size: small;"><span class="t102"><span style="line-height: 115%;"><a href="http://esubmission.emea.europa.eu/tiges/docs/EU%20eCTD%20and%20NeeS%20Validation%20Criteria%20July%202012.pdf">http://esubmission.emea.europa.eu/tiges/docs/EU%20eCTD%20and%20NeeS%20Validation%20Criteria%20July%202012.pdf</a></span></span></span></div>
<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif;">
<br /></div>
<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif;">
<b><span style="font-size: small;">Webinar Question answer </span></b></div>
<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif;">
<br /></div>
<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif;">
<span style="font-size: small;"><span class="t102"><span style="line-height: 115%;"><a href="http://esubmission.emea.europa.eu/tiges/docs/Questions%20and%20Answers%20from%20the%20TIGes%20Webinar%20Friday%2013%20July%202012_for%20publication.pdf">http://esubmission.emea.europa.eu/tiges/docs/Questions%20and%20Answers%20from%20the%20TIGes%20Webinar%20Friday%2013%20July%202012_for%20publication.pdf</a></span></span></span></div>
</div>Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-7970229075962471262012-07-24T23:50:00.002-07:002012-07-24T23:51:41.603-07:00THE eCTD SUMMIT: Are you Ready for the eCTD Mandate?<div dir="ltr" style="text-align: left;" trbidi="on">
<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif; margin: 0in 0in 10pt; text-align: justify;">
<span style="font-size: small;"><span>With
the FDA Safety & Innovation Act now signed into law, life science
companies will need to start thinking strategically about the impact of
the electronic submission mandate and how to quickly and easily comply.
Since most of the larger companies already submit electronically, the
greatest impact will be to the smaller, virtual companies that do not
have substantial IT infrastructure in place, and lack the overall
budgetary flexibility of their larger peers. </span></span></div>
<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif; margin: 0in 0in 10pt; text-align: justify;">
<span style="font-size: small;"><span>One
benefit for these smaller companies is that the FDA will provide 36
months for compliance for those companies that will submit original IND
submissions and amendments after final guidance is provided, instead of
24 months for NDA and BLA submissions. With that being said, the time
is now to prepare and plan for electronic submissions. Companies must
decide the best avenue for compliance whether it is bringing publishing
in-house, outsourcing, or utilizing a combination of the two. </span></span></div>
<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif; margin: 0in 0in 10pt; text-align: justify;">
<span style="font-size: small;"><span>To find more information please use the below mentioned weblink</span></span></div>
<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif; margin: 0in 0in 10pt; text-align: justify;">
<b><a href="http://theectdsummit.com/?p=2082"><span style="font-size: small;"><span>http://theectdsummit.com/?p=2082</span></span></a></b></div>
<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif; margin: 0in 0in 10pt; text-align: justify;">
<span style="font-size: small;"><span> </span></span></div>
<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif; margin: 0in 0in 10pt; text-align: justify;">
<br /></div>
</div>Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-79150707084828213232012-07-24T23:49:00.003-07:002012-07-24T23:49:53.486-07:00Health Denmark: Guidelines for electronic applications<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<span>Although guidelines for requirements regarding.</span> <span>
how to submit electronic applications to the Board of Health, has long
been to find on the site, wants the Board of Health to focus on them
again.</span></div>
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<span> </span> </div>
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<span> Due to Board of Health experience with errors submissions, we want to refer to a rereading of the information here.</span></div>
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<span> </span> </div>
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<span> The full document concerning. <a href="http://translate.googleusercontent.com/translate_c?hl=en&prev=/search%3Fq%3Dectd%2B-job%2B-jobs%2B-globalsubmit%26hl%3Den%26sa%3DX%26tbo%3D1%26rlz%3D1T4ADRA_enUS493US493%26biw%3D1920%26bih%3D873%26tbs%3Dqdr:d%26prmd%3Dimvnsl&rurl=translate.google.com&sl=da&u=http://laegemiddelstyrelsen.dk/da/topics/godkendelse-og-kontrol/godkendelse-af-laegemidler/markedsfoeringstilladelse/ansoegning-om-markedsfoeringstilladelse/retningslinjer-for-elektroniske-ansoegninger.aspx&usg=ALkJrhhK0d3Vvpid6V2-k1H75jlywgy0eg">Guidelines for electronic applications can be found here.</a></span> </div>
<div style="font-family: Arial,Helvetica,sans-serif;">
<span>
Short, we must recall that we distinguish between "applications" and
"submissions" so that an application may consist of one or more
submissions:</span></div>
<div style="font-family: Arial,Helvetica,sans-serif;">
<br /></div>
<div style="font-family: Arial,Helvetica,sans-serif;">
<span>To find more information please use the below mentioned weblink</span></div>
<div style="font-family: Arial,Helvetica,sans-serif;">
<br /></div>
<div style="font-family: Arial,Helvetica,sans-serif;">
<b><a href="http://translate.google.com/translate?hl=en&sl=da&u=http://laegemiddelstyrelsen.dk/da/topics/godkendelse-og-kontrol/godkendelse-af-laegemidler/nyheder/opdatering-af-retningslinjer-for-elektro--tilladelse&prev=/search%3Fq%3Dectd%2B-job%2B-jobs%2B-globalsubmit%26hl%3Den%26sa%3DX%26tbo%3D1%26rlz%3D1T4ADRA_enUS493US493%26biw%3D1920%26bih%3D873%26tbs%3Dqdr:d%26prmd%3Dimvnsl&sa=X&ei=WwkPUM_rFsXk0QHU_IGoCA&ved=0CG4Q7gEwAg"><span>http://translate.google.com/translate?hl=en&sl=da&u=http://laegemiddelstyrelsen.dk/da/topics/godkendelse-og-kontrol/godkendelse-af-laegemidler/nyheder/opdatering-af-retningslinjer-for-elektro--tilladelse&prev=/search%3Fq%3Dectd%2B-job%2B-jobs%2B-globalsubmit%26hl%3Den%26sa%3DX%26tbo%3D1%26rlz%3D1T4ADRA_enUS493US493%26biw%3D1920%26bih%3D873%26tbs%3Dqdr:d%26prmd%3Dimvnsl&sa=X&ei=WwkPUM_rFsXk0QHU_IGoCA&ved=0CG4Q7gEwAg</span></a></b></div>
<div style="font-family: Arial,Helvetica,sans-serif;">
<span> </span> </div>
</div>Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0tag:blogger.com,1999:blog-3768695149152354592.post-89760613170121465872012-07-19T09:56:00.003-07:002012-07-19T09:56:39.883-07:00CSC: What was the part in the middle? FDA's Module 1 v2 - Applications, Submissions and Sequences - By Joel Finkle<div dir="ltr" style="text-align: left;" trbidi="on">
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<br />
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<span style="font-size: small;">The question above is the response of Otto, the dimwitted assassin
brilliantly played by Kevin Kline in the movie "A Fish Called Wanda" when
presented with too many choices. While not really applicable to FDA's Module 1
version 2, which is coming regardless, it's the middle part that has caused a
lot of confusion, and it needs to get more complex, while at the same time
become more clear... got it?</span></div>
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<br /></div>
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<span style="font-size: small;">Let's take it from the top: FDA's eCTD submissions have always included
three numbers: An application number (NDA, aNDA, BLA, or IND), a sequence
number (starting at 0000), and a related sequence number. There has always been
confusion about the related sequence number, and despite several FDA
presentations, sequencing has been a common source of errors in filing an eCTD.</span></div>
<div style="font-family: Arial,Helvetica,sans-serif; text-align: justify;">
<br /></div>
<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif; line-height: normal; text-align: justify;">
<span style="font-size: small;"><span>To find more information please use the below
mentioned weblink</span></span></div>
<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif; line-height: normal; text-align: justify;">
<br /></div>
<div class="MsoNormal" style="font-family: Arial,Helvetica,sans-serif; line-height: normal; text-align: justify;">
<b><span style="font-size: small;"><span><a href="http://www.csc.com/health_services/blog/74101/86381-what_was_the_part_in_the_middle_fda_s_module_1_v2_applications_submissions_and_sequences">http://www.csc.com/health_services/blog/74101/86381-what_was_the_part_in_the_middle_fda_s_module_1_v2_applications_submissions_and_sequences</a></span></span></b></div>
</div>Anonymoushttp://www.blogger.com/profile/08833716636252546383noreply@blogger.com0