FDA : Affordable Care Act (ACA 6004) - Updates

FDA has updated Affordable Care Act (ACA 6004) submission web page.

Please find more information by clicking the below mentioned weblink

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm292040.htm?source=govdelivery

Exalon: Spanish Medicines Agency updates national electronic submission guidance

The new version puts more emphasize on the possibility to switch dossier formats. The general schedule only allows to switch from paper -> NeeS -> eCTD or directly from paper -> eCTD but not backwards. Exceptions may be allowed in very rare cases that need to be duly justified (e.g. change of ownership etc.).

To find more information please find below mentioned Exalon weblink

http://www.exalon.com/ectd-news/news-details/article/spanish-medicines-agency-updates-national-electronic-submission-guidance.html

Exalon: EMA issues new version of the Post-authorization procedural advice for users of the Centralized Procedure

The European Medicines Agency (EMA or the Agency) has released a further update of their "Post-authorization procedural advice for users of the centralized procedure", document EMEA-H-19984/03.

The current revision 23 contains only two notable updates:

   1. Question 1.8 dealing with the fees applicable for Type IA/IAIN variations: The Agency will now issue an invoice upon receipt of the Type IA/IAIN variation and fees must be paid within 45 calendar days of the date of the said notification. Previously the invoice was issued by the Agency on the date of the notification of the review outcome to the applicant.

   2. Question 18.4 dealing with changes in contact persons mentioned in the application form: This question contains now explicit detailed explanations how to deal with a change to the contact person at the MAH address (section 2.4.1 of the application form) or with a change to the person/company authorised for communication between the MAH and the Agency (sections 2.4.2 and 2.4.3 of the application form).

To find more information please use the below mentioned Exalon weblink 

http://www.exalon.com/ectd-news/news-details/article/ema-issues-new-version-of-the-post-authorization-procedural-advice-for-users-of-the-centralized-proc.html

Ask Cato: PDUFA V: A Funny Sounding Name for a Very Important Bill

Can you say PDUFA (pŭ-dōō-fŭ)?  The United States Senate can.  A very partisan Senate showed uncharacteristically bipartisan support for the Prescription Drug and User Fee Act (PDUFA) V, voting on 24 May 2012 to reauthorize PDUFA by a 96 to 1 vote.  This reauthorization allows for a 6% increase in fees paid by drug and medical device manufacturers to fund the FDA’s approval process.  PDUFA IV expires on 30 September 2012, and PDUFA V, if passed by the House and signed into law, will allow the FDA to collect user fees for the review of human drug and device applications for fiscal years 2013 through 2017.

PDUFA was first passed in 1992.  It mandated that manufacturers of new drugs pay a fee upon submitting a New Drug Application (NDA).  The increase in revenue to the FDA from these fees was used to decrease the time between a NDA submission and a FDA decision.  Indeed, review times did decrease, and PFUFA II was passed in 1997, III in 2002, and IV in 2007.  Each reauthorization of PDUFA implemented fees to modernize and accelerate processes for drug and medical device approval.

To find more information please use the below mentioned weblink 

http://www.ask-cato.com/2012/05/pdufa-v-a-funny-sounding-name-for-a-very-important-bill/?utm_source=rss&utm_medium=rss&utm_campaign=pdufa-v-a-funny-sounding-name-for-a-very-important-bill

 

 

EMA has released XEVMPD controlled vocabularies for organizations (version 4.0) and Substances (version 5.0).

To find more information and download the updated sheet please use the below mentioned weblinks 

Extended EudraVigilance Product report message (XEVMPD) organisations, version 4.0

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/03/WC500123647.xls

Extended EudraVigilance Product report message (XEVMPD) substances, version 5.0

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/03/WC500123652.xls

RAPS: EMA Releases Guidance on Electronic Submission of Veterinary Applications

The European Medicines Agency (EMA) released a new question and answer guidance document on 22 May to assist sponsors with submitting their veterinary dossiers in an electronic format.

The document, Electronic submission of veterinary dossiers: Questions and answers, provides answers to a number of common questions.

Sponsors submitting via the centralized application procedure are encouraged—but not required—to submit their veterinary dossiers to EMA, though sponsors who have submitted electronic dossiers to EMA in the past are required to keep it updated electronically.

To find more information please use the below mentioned weblink

http://www.raps.org/focus-online/news/news-article-view/article/1554/ema-releases-guidance-on-electronic-submission-of-veterinary-applications.aspx

Exalon: Swissmedic releases version 1.4 of their national "Q&A of Swissmedic eCTD Implementation

The Swiss national drug regulatory agency Swissmedic has released an updated version of their "Questions & Answers of Swissmedic eCTD Implementation". The Q&A document "aims to address the commonly-asked questions and provide guidance on Swissmedic's plans to implement electronic-only submissions with eCTD". 

The Q&A is intended to be a "living" document, thus Swissmedic encourages applicants, other regulators, consultants and vendors to give feedback. 

The new version of the Q & A document (clean and Marked) avilable in the below mentioned weblink 

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

 

 

Exalon: EMA launches XEVMPD e-learning course to support Article 57(2) compliance and further updates XEVMPD controlled vocabularies

The European Medicines Agency (EMA) has launched the long-awaited XEVMPD e-learning course to support compliance of Marketing Authorisation Holders (MAHs) with Art. 57 (2) of Regulation (EC) No. 726/2004.

The course is comprised of six modules which cover:

1. Introduction to the Eudravigilance system
2. Regulatory background
3. XEVMPD architecture
4. Submission of the XEVPRM with practical examples
5. XEVMPD data entry tool EVWEB
6. XEVPRM operation types

 The XEVMPD e-Learning course is freely accessible via the following methods:

    * Streaming (via YouTube)
    * Downloading the videos (announced to be available during this week)
    * Podcast via iTunes or RSS (announced to be available during this week)

To find more information please use the below mentioned weblink 

http://www.exalon.com/ectd-news/news-details/article/ema-launches-xevmpd-e-learning-course-to-support-article-572-compliance-and-further-updates-xevmpd.html

THE eCTD SUMMIT: How the FDA uses REVIEW and VALIDATE

Each center, division, and reviewer uses GlobalSubmit REVIEW™ and VALIDATE™ differently.

Besides loading and validating submissions, VALIDATE is used to reject submissions for technical reasons. If VALIDATE reports a high error, your submission could be rejected. This rejection could take up to five days to be reported. When an original or supplement is rejected, your PDUFA time clock will not start.

Some divisions in the FDA have what is called an integrity reviewer. The integrity reviewer uses the VALIDATE report with REVIEW to ensure the submission is reviewable. This reviewer checks for many deficiencies, including but not limited to, broken hyperlinks, missing content, and STF files that are provided.

To find more information please use the below mentioned weblink

THE eCTD SUMMIT: How the FDA uses REVIEW and VALIDATE

 

CSC: Beyond EVMPD - IDMP! - Joel Finkle

As we've been telling you, the EU requires that all marketed products must be registered with the Eudravigilance Medical Product Dictionary (EVMPD) in the new Extended format (XEVMPD, or rather XEVPRM for the Extended Eudravigilance Product Report Message). However, the EU recognizes that this is a stopgap measure. There's another standard called IDMP, for Identification of Medical Products, that's just on the horizon. IDMP was developed at Health Level Seven (HL7), and shares some components with Structured Product Labeling (SPL), which was also developed by HL7 -- namely the Common Product Model. It completed balloting as of April 23, 2012, as a Final Draft Standard, with the anticipation that it will be finalized by the end of the year – the development of an Implementation Guide being a major development still to be completed. The expectation is that it will be implemented in 2015 -- that should be a much more comfortable time for implementation than the EU gave for XEVMPD, but it will still be challenging.

To find more information please use the below mentioned weblink 

http://www.csc.com/health_services/blog/74101/83494-beyond_evmpd_idmp

European Medicines Agency launches new e-learning course for Article 57 (2) requirements on submission of information on medicines (XEVMPD on-line e-learning)

The European Medicines Agency has launched an e-learning course for marketing authorisation holders to support compliance with Article 57(2) on the submission of information on medicines, one of the key measures of the new pharmacovigilance legislation. 

The course is comprised of six modules which cover: 

• an introduction to the Eudravigilance system;
• the regulatory background;
• the architecture of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD);
• submission of the eXtended EudraVigilance Product Report Message (XEVPRM) with practical examples, and;
• the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) data entry tool also known as EVWEB. 

To find more information please use the below mentioned weblinks

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/04/news_detail_001489.jsp&mid=WC0b01ac058004d5c1

http://eudravigilance.ema.europa.eu/human/training7.asp