News Archive

FDA issues draft guidance for the submission of manufacturing establishment information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The FDA has released a draft guidance "Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information", dated December 2016....[mehr]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

CDER to issue 3rd Acknowledgement for Successful eCTD Submissions

19.05.2016
Flag of USA

Beginning May 31, 2016, CDER will begin issuing an acknowledgement to FDA Electronic Submissions Gateway (ESG) users when their NDA, ANDA, BLA, IND or DMF submission has...[mehr]

South African MCC releases updated eCTD Q&A

06.05.2016
Flag of South Africa

The Medicines Control Council (MCC) of South Africa has released an updated version of the "Questions & Answers Implementation of eCTD in South Africa". The new...[mehr]

Lithuanian SMC switches to e-dossier only starting 01 May 2016

02.05.2016
Flag of Lithuania

Starting from the 1st of May, 2016, State Medicines Control Agency (SMCA) switches to e-submission (e-dossier) only. All applications for marketing authorization, renewal, all...[mehr]

New draft version of EU eCTD Module 1 v3.0 released for public consultation

22.07.2015
Flag of EU

A new draft revision of the future version 3.0 for the EU eCTD Module 1 has been released on the CMB eSubmission website. The release consists of the following documents:

Release...[mehr]

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