EMA Publishes Updated Guidance on Premarketing, Postmarketing Procedures
The European Medicines Agency (EMA) has released updated guidance on procedural advice for its post-authorization and pre-authorization procedural advice, providing regulatory professionals with comprehensive and integrated lists of the answers to most questions regarding the authorization procedure.
EMA's 26 April guidances cover questions and answers applicable to the pre- and post-submission timeframes, and are frequently updated.
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European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure