EMA to Release New Module 1 Specification (v1.4) in August

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EMEA has announced that they will be releasing a new M1 eCTD specification in early August. EMEA will be releasing version 1.4, including a new DTD, implementation guide, transition guide, and validation guide.  According to Claire Holmes of EMEA, this new version will accommodate recent updates to guidance on variations.

The new version will be recommended from January 2010, and mandatory from February 2010.

Gary Gensinger of the FDA has also confirmed that a new US module 1 specification is in the works, with no target date announced yet.

As I reported earlier in the week, SwissMedic has released their draft eCTD M1 specification and validation criteria. Stephan Jaermann of SwissMedic has stated that additional documentation – Guidance for Industry and Q&A – will follow soon. The SwissMedic pilot program will continue through October, with implementation to follow. Initially, only MAAs will be accepted, with Variations accepted in a future phase. SwissMedic will still accept paper submissions for the foreseeable future, but all electronic submissions must be in eCTD format (no NeeS).

Addendum: SwissMedic has as of July 17 published Guidance for Industry on Providing Regulatory Information in eCTD Format and Questions and Answers of Swissmedic eCTD Implementation.

Author: GS

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