EMEA and PMDA Update at DIA

EMEA and PMDA provided an update on eCTD status at the traditional "Update on Regulatory Authority Experience" session.

Tim Buxton was the speaker from EMEA. He provided the following statistics on eCTDs received between July and December 2007:

• Centralised Procedure: 14 new applications, 80 variations
• National Procedures (as reported by national compentent authorities): 659 new applications, 611 variations

Tim also mentioned that seven EU authorities already accept eCTD only without paper.

Next, Tim discussed the new EU M1 guidance, which incorporates 24 change requests. Tim stressed that this guidance is mandatory by December 31, 2008, and that this is a hard deadline because the most significant change, which is related to pediatric information, is needed immediately (in the short term, put this in the "Other" slot in M1). He also mentioned that the new tracking table for MRP/DCP goes into the same slot as the cover letter.

To access the new M1 specification, see http://esubmission.emea.europa.eu/eumodule1/docs/EU%20M1%201.2.1/EU%20%20M1%201.3/EU%20M1%20Specification%20v1.3%20FINAL%20.zip

To access the underlying CTD Guidance "Volume 2B Notice to Applicants: Medicinal products for human use: Presentation and format of the dossier: Common Technical Document (CTD), see http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/b/update_200805/ctd_05-2008.pdf

Tim discussed the (relatively) new XML application. The EMEA has been disappointed that sponsors are not using it more extensively, and would like to encourage sponsors to begin using it as soon as practical.

Tim was asked about the intention of developing a submission gateway. The EMEA already has a gateway for ISCRs, similar to the FDA's. They plan on developing a gateway for eCTD, but are not able to announce a date at this point.

Yasuhiro Araki spoke next, representing PMDA. He presented the eCTD review process in detail. PMDA is ready and able to accept eCTDs and has developed tools and processes in support of eCTD, but as of May 2008 has received only 9 original applications (17 sequences) and 71 reference applications (100 sequences). Reference applications are essentially review aids with paper being the official copy.

Japan still needs paper for M1 and M2 - the main reason for thisis the use of external experts in the review process.

Some news from the regulators

I attended a session at the DIA annual meeting where the regulators spoke about the status of eCTD in their regions. I'll give some updates from EU and Japan in my next post; today's post focuses on FDA updates.

Gary Gensinger gave the US eSubmission update. The most interesting point that Gary made was in the "myth busting" department. Gary told us "There is no advantage to submitting in paper over electronic. In fact, it's the opposite - you are likely to get more questions." This stands to reason if you put yourself in the reviewer's shoes. For eCTD, the reviewer finds all of the documents organized in a well understood structure, can search for documents using a full text index, and can access documents instantly. For paper, the reviewer must determine which volume he or she needs, retrieve it from a document room, and deal with the delay if someone else has already checked it out.

Gary listed the advantages of eCTD as seen by FDA as:

• Supporting a better, more comprehensive review


• Providing for a more efficient and effective review process


• Promoting standardization


• Promoting operational efficiency

Gary was enthusiastic about the gateway, especially combined with the eCTD format. He mentioned that with an eNDA, a submission took two to three days to reach reviewers, but an eCTD submitted through the gateway reaches reviewers in as little as an hour. The agency persective dovetailed nicely with what I have been hearing from sponsors. For example, Monte Levinson of Zymogenetics, as part of the excellent presentation "IND in eCTD Format: eCTD on a Shoestring", mentioned that use of the gateway is a key part of his company's motivation for moving to eCTD, and that cutting days off the schedule for printing, binding, and delivery is seen as a huge benefit in his organization. Other sponsors were interested to learn that the gateway can be used even if submissions are outsourced provided the right authorizations are filed.

In another session, Joe Montgomery of the FDA addressed recent problems some applicants experienced with the gateway. It turns out that submissions of > 70 GB sometimes time out - FDA expects this problem to be fixed soon.

Up and Running!

To all who have had a look at this blog and were interested, but disappointed to see that there were no recent posts - we started the blog some time ago but experienced some delays in posting to search engines. We're up and running now, and I will be blogging in the near future about updated guidance issued by FDA and EMEA, some interesting news from the recent DIA annual meeting in Boston, and much more!