News Archive

CDER to issue 3rd Acknowledgement for Successful eCTD Submissions

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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...[more]

South African MCC releases updated eCTD Q&A

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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...[more]

Lithuanian SMC switches to e-dossier only starting 01 May 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...[more]

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

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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:


Mandatory usage of Central Repository; updated EMA Dossier Requirements

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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...[more]

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

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

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

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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...[more]

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