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