News Archive

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The U.S. FDA has released a new draft guidance, dated June 2014 Providing Submissions in Electronic Format - Postmarketing Safety Reports This new draft revises and supersedes the...[mehr]

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...[mehr]

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...[mehr]

Romanian ANMDM joins CESP - Update from June 12, 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.


EMA updates dossier requirements for centrally authorised human medicinal products


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,...[mehr]

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

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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...[mehr]

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

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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...[mehr]

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