News Archive

FDA issues new draft for electronic submissions of Postmarketing Safety Reports

04.07.2014
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The U.S. FDA has released a new draft guidance, dated June 2014 Providing Submissions in Electronic Format - Postmarketing Safety Reports This new draft revises and supersedes the...[more]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

01.07.2014
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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

18.06.2014
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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]

Romanian ANMDM joins CESP - Update from June 12, 2014

12.06.2014
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The Romanian National Agency for Medicines and Medical Devices (ANMDM) has joined the Common European Submission Platform (CESP) system as announced on June 02 by CESP.

According...[more]

EMA updates dossier requirements for centrally authorised human medicinal products

30.05.2014

The European Medicines Agency has released a further update of the "Dossier requirements for centrally authorised products". As part of the update the new revision 8,...[more]

FDA ESG provides new WebTrader Hosted Solution as alternative to the ESG

30.05.2014
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The US FDA has recently notified users of the Electronic Submissions Gateway (ESG) of a new capability which will be available starting June 01, 2014 - The WebTrader Hosted...[more]

French ANSM launches step III of it's CESP pilot phase

15.05.2014
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The French drug regulatory agency ANSM has recently announced to lauch step III of it's CESP pilot program. As communicated earlier the ANSM took a stepwise approach to accept...[more]

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