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

 

Exalon: CMDh releases updated guidance documents regarding submission of variations

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. 

The update concerns the corresponding Q/A list (document CMDh/132/2009) which has been released as revision 13, dated June 2012 (available as "clean version" and "track-change version"). Compared with revision 12, the update contains the following changes:

• 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" 
• 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)

To find more information please use the below mentioned weblink    

http://www.exalon.com/ectd-news/news-details/article/cmdh-releases-updated-guidance-documents-regarding-submission-of-variations.html

 

EU validation criteria v4.1 (eCTD) & v3.0 (Nees) – Webinar Slides are available for Reference

The TIGes Harmonization has conducted EU validation webinar on Friday 13 July 2012. 

The slides that were presented at the Webinar are available for reference 

Webinar Slides

http://esubmission.emea.europa.eu/tiges/docs/EU%20eCTD%20and%20NeeS%20Validation%20Criteria%20July%202012.pdf

Webinar Question answer 

http://esubmission.emea.europa.eu/tiges/docs/Questions%20and%20Answers%20from%20the%20TIGes%20Webinar%20Friday%2013%20July%202012_for%20publication.pdf

THE eCTD SUMMIT: Are you Ready for the eCTD Mandate?

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.

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. 

To find more information please use the below mentioned weblink

http://theectdsummit.com/?p=2082

 

Health Denmark: Guidelines for electronic applications

Although guidelines for requirements regarding. 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.

 

Due to Board of Health experience with errors submissions, we want to refer to a rereading of the information here.

 

The full document concerning. Guidelines for electronic applications can be found here.

Short, we must recall that we distinguish between "applications" and "submissions" so that an application may consist of one or more submissions:

To find more information please use the below mentioned weblink

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

 

CSC: What was the part in the middle? FDA's Module 1 v2 - Applications, Submissions and Sequences - By Joel Finkle

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?

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.

To find more information please use the below mentioned weblink

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

EMA: New versions of the Electronic Application Forms for MAA-Human, MAA-Vet, Renewals and Variations has released

EMA: New versions of the Electronic Application Forms for MAA-Human, MAA-Vet, Renewals and Variations has released

http://esubmission.emea.europa.eu/eaf/index.html

EMA eSubmission Gateway: Questions and answers relating to practical and technical aspects of the implementation (Guidance has been updated on 16th July 2012)

EMA eSubmission Gateway: Questions and answers relating to practical and technical aspects of the implementation (Guidance has been updated on 16th July 2012)

http://esubmission.emea.europa.eu/gateway/Q%20&%20A%20for%20EMA%20eSubmission%20Gateway.pdf