eCTD News

FDA issues draft guidance for the submission of manufacturing establishment information

06.01.2017
Flag of USA

The FDA has released a draft guidance "Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information", dated December 2016....[mehr]

South Africa: MCC releases updated Module 1 eCTD specification and validation criteria

02.12.2016
Flag of South Africa

The MCC (Medicines Control Council) of South Afrika has released updated versions of their Module 1 eCTD specification (version 2.1) and corresponding South African validation...[mehr]

EDQM releases updated guidance and roadmap for electronic CEP applications

01.12.2016
Council of Europe

The EDQM has released a new version of the "Guidance for electronic submissionsfor Certificates of Suitability (CEP) applications", PA/PH/CEP (09) 108, 4R and the...[mehr]

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