News Archive

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The U.S. FDA has released a new draft guidance, dated June 2014 Providing Submissions in Electronic Format - Postmarketing Safety Reports This new draft revises and supersedes the...[more]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

Czech Republic SUKL updates submission requirements for Centralized Procedure submissions

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The Czech National Drug Regulatory Agency SUKL has announced that for eCTD submissions in the EU Centralized Procedure additional copies sent via CDs/DVDs by mail to SUKL are no...[more]

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