Health Canada to Use US FDA’s Electronic Submission Gateway (ESG) for eCTD Submissions

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.

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.

Michael Fauntleroy, Program Manager of FDA’s Electronic Submissions Gateway, noted during a presentation for the GDUFA Conference in Silver Spring, MD on 13^th 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.

Find link to a summary of the plan and goals from a Canadian government website.

http://actionplan.gc.ca/en/page/rcc-ccr/common-electronic-submissions-gateway-esg-work-plan

New Swissmedic Technical Validation Form

Swissmedic released a new technical validation form to use for Swiss eCTDs submission

For more information

http://www.swissmedic.ch/zulassungen/00933/00937/01399/index.html?lang=en

EMA – Revised Implementation Guide for EU Module 1, eCTD/NeeS validation Criteria

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)

You find further information and a link to the Implementation Guide on EMA’s esubmission webpage at

http://esubmission.emea.europa.eu/

For more information on the EU Module 1 v2.0 follow the link below

http://esubmission.emea.europa.eu/eumodule1/index.htm

The eCTD Summit: Automated Review Increases Vulnerability to Rejection

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.

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.
With the human element gone from the process, there is no flexibility, no margin for error.

The Agency recently updated to eCTD Validation Criteria Version 2.2, giving them the capability to accept or reject a submission on technical merit without the possibility of human intervention.
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.

For more information

http://theectdsummit.com/?p=2336

CH eCTD Module 1 specification 1.2 released by Swissmedic

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

• eCTD CH Module 1 specification 1.2 ("clean" version and "track change" version)
  
  • Implementation guidance
  • DTD
  • Style sheet
  • Examples
  • Checksum document
• Guidance for Industry on Providing Regulatory Information in eCTD Format v1.4 ("clean" version and "track change" version)
• Q&A v1.6 ("clean" version and "track change" version)
• Validation criteria v1.2
• Release notes for the new validation criteria v1.2

Implementation schedule:
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 . From January 01, 2014 the usage of the new CH Module 1 specification 1.2 will be mandatory for eCTD submissions to Swissmedic. Note that eCTDs that have switched to the new version 1.2 during the transition period cannot be switched back to version 1.1.

Guidance for Industry:
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.

Q&A:
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.

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.

eCTD Validation Criteria:
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.

Swiss eCTD Module 1 specification 1.2:

Numerous changes have been introduced, the key changes are:

• 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.
• Table 1 detailing the possible switch to a subfolder "common" for a Module 1 with a 2^nd galenic form branch for certain documents and the corresponding allowed life cycle operation attributes have been updated completely.
• Clarification regarding country codes for United Kingdom ("uk" allowed), Greece ("el" allowed) and EU Centralized ("ema" or "emea" allowed) has been introduced
• 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.
• Additional directory / file names have been specified for some forms. This resulted in new subsections 1.2.2.21 - 1.2.2.24.
• Appendix 2 with the "Envelope Element Description" has been largely updated

For More information

http://www.swissmedic.ch/zulassungen/00933/00937/index.html?lang=en

EMA: Implementation guide for EU Module 1 Specification, version 2.0 released

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).

According to this implementation guide the new EU Validation Criteria for eCTD and NeeS will come into force on 01 September 2013 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.

Regarding the new EU Module 1 that has been published in 01 March 2013 a transition period for will be established:

1. Starting from 01 July 2013 applicants can submit either eCTDs compliant with EU Module v. 1.4.1 (applying eCTD validation criteria 4.1) or EU Module v. 2.0 (applying eCTD validation criteria 5.0)
2. From 01 September 2013 only eCTDs compliant with EU Module 1 v. 2.0 will be accepted.

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.

Guidance on how to submit information relevant to Croatia:

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.

 

For More Information

 

http://esubmission.emea.europa.eu/index.htm

Meeting of Czech and Slovak colleagues have been devoted to the problem eCTD

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.

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.

To find more information please use the below mentioned weblink

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

Mission3: President Obama Signs PDUFA Reauthorization

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.

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.

To find more information please use the below mentioned weblink

http://mission3.com/company/newsletter/122

CSC: 2015 - the Mayans may have been off by three years – By Joel Finkle, Senior Strategist, Regulatory Services Delivery

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:

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

2) The IDMP ISO standard will be required for product registrations

3) FDA will require all NDAs to be in eCTD format

To find more information please use the below mentioned weblink

http://www.csc.com/health_services/blog/74101/88217-2015_the_mayans_may_have_been_off_by_three_years

CSC: Fourth Time’s the Charm: eCTD 4.0 is coming!

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.

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.

Why can’t we “leaf” it alone?

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).

To find more information please use the below mentioned weblink

http://www.csc.com/health_services/blog/74101/87525-fourth_time_s_the_charm_ectd_4_0_is_coming

FDA releases final version 2.0 of the US eCTD Module 1 specification

The U.S. Food and Drug Administration (FDA) has released the final version 2.0 of the regional US eCTD Module 1 specification files.

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).

To find more information please use the below mentioned weblink

http://www.exalon.com/ectd-news/news-details/article/fda-releases-final-version-20-of-the-us-ectd-module-1-specification.html

Exalon: EU: New draft eCTD guidance for ASMFs released

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.

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.

To find more information please use the below mentioned web link

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

Exalon: EMA releases another update of the CHMP dossier requirements

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:

•The representative for Czech Republic was changed to "Awaiting Nomination"

•The address for the representative of Iceland (Kolbeinn Gudmundsson) has been corrected

•The representative for Portugal did change from Beatriz Silva Lima to Bruno Sepodes. The corresponding address was updated.

•The representative for Slovenia was changed to "Awaiting Nomination"

There are no changes regarding the requirements of CD-ROM copies for the CHMP members.

To find more information please use the below mentioned weblink

http://www.exalon.com/ectd-news/news-details/article/ema-releases-another-update-of-the-chmp-dossier-requirements.html

FDA: New Study Data Exchange Format – Requesting Comments & Holding Meeting

The FDA is requesting comments from industry and the public on the development of standards for study data exchange standards.

In Federal Register notice, FDA mentioned that they are holding a meeting to assess the suitability of the current study data exchange format, 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.

To fine more information please use the below mentioned weblink

https://www.federalregister.gov/articles/2012/08/14/2012-19748/solutions-for-study-data-exchange-standards-meeting-request-for-comments-regulatory-new-drug-review

Breaking Regulatory Update for Life Science Firms – UFA Requirements for eCTDs

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!

Details:

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.

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.

To find more information please use the below mentioned weblink

http://www.expertbriefings.com/events/breaking-regulatory-update-for-life-science-firms-ufa-requirements-for-ectds-sept-12-2012-2-330-pm-edt-azevedo/

Danish: Closer attention to guidelines on submission of electronic applications for marketing authorisations

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.

As we have received a number of incorrect submissions, we kindly request applicants to read through the guidelines once more:

Guidelines on submission of electronic applications

Briefly stated, we remind applicants that we distinguish between "applications" and "submissions" in that one application consists of one or several submissions.

To find more information use the below mentioned weblink

http://laegemiddelstyrelsen.dk/en/topics/authorisation-and-supervision/licensing-of-medicines/news/closer-attention-to-guidelines-on-submis--orisations

Accenture acquiring Octagon Research Solutions

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.

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.

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.

To find more information please use the below mentioned web link

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

CSC: “As Advertised” - FDA Module 1 Continued – By Joel Finkle, Senior Strategist, Regulatory Services Delivery

Picking up where we left off last time on the FDA Module 1 changes 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.

Promotional Materials

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.

 To find more information use the below mentioned weblink

http://www.csc.com/health_services/blog/74101/87030-as_advertised_fda_module_1_continued

FDA eSubmission: Transmission Specifications – Guidance Updated

We can find clarification that USB encryption is optional Rewording information regarding password protection of data vs. USB drive

To find updated guidance use the below mentioned weblink

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163567.pdf

RAPS: EU Regulators Expand Electronic Submission Program, Recommend Wider Use

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.

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.

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.

The pilot phase of the program 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."

To find more information please use the below mentioned weblink

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