News Archive

French ANSM updates national Notice to Applicants

La Tricolore

The French drug regulatory agency ANSM has released an updated version of their national Notice to Applicants, dated September 2014.

This guidance describes the submission...[more]

Updates to EMA Dossier requirements

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EMA has released several updates to the Dossier requirements for Centrally Authorised Products (CAPs) during the past weeks.

The latest revision 13, dated 10 September 2014 is...[more]

EMA udpates Pre-Authorisation and Post-Authorisation Q&A documents

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EMA has released updates to their "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure" and the "European Medicines...[more]

Australian TGA releases technical eCTD files and further info to eCTD pilot

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The Australian Therapeutic Goods Administration (TGA) has released more information to their eCTD Module 1 specification:

The eCTD technical files required to publish eCTDs...[more]

Thai FDA releases draft eCTD specification and validation criteria

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The Thai Drug Control Division (TDCD) a Division of the Thai Food and Drug Administration has released information about the Thai eSubmission project on the website of the...[more]

FDA issues new draft for electronic submissions of Postmarketing Safety Reports

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The U.S. FDA has released a new draft guidance, dated June 2014 Providing Submissions in Electronic Format - Postmarketing Safety Reports This new draft revises and supersedes the...[more]

Australian TGA releases eCTD specification and guidance

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The long-awaited eCTD specification for Australia has been released by the Therapeutic Goods Administration (TGA) recently.

Earlier this year, the TGA already announced to have...[more]

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