News Archive

CDER to issue 3rd Acknowledgement for Successful eCTD Submissions

19.05.2016
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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
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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
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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]

Mandatory usage of Central Repository; updated EMA Dossier Requirements

01.07.2015
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Starting from July 01, 2015 the use of the Common Repository is mandatory for all Human Medicinal Product submissions in the Centralized Procedure. All National Competent...[mehr]

FDA releases final guidance for certain human pharmaceutical product applications; mandates eCTD submissions

19.05.2015
Stars and Stripes

The Food and Drug Administration (FDA) has finally released the final Guidance for Industry "Providing Regulatory Submissions in Electronic Format —Certain Human...[mehr]

EMA releases revision 18 of the Dossier requirements for Centrally Authorised Products

15.05.2015
Flag of EU

The European Medicines Agency (EMA) has released a new revision 18 of the "Dossier requirements for Centrally Authorised Products (CAPs)".

Revision 18, dated 08 May...[mehr]

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