News Archive

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...[more]

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...[more]

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...[more]

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...[more]

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...[more]

Mandatory usage of Central Repository; updated EMA Dossier Requirements

01.07.2015
Flag of EU

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

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...[more]

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