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.