News Archive

Mandatory usage of Central Repository; updated EMA Dossier Requirements

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Starting from July 01, 2015 the use of the Common Repository is mandatory for all Human Medicinal Product submissions in the Centralized Procedure. All National Competent...[more]

FDA releases final guidance for certain human pharmaceutical product applications; mandates eCTD submissions

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The Food and Drug Administration (FDA) has finally released the final Guidance for Industry "Providing Regulatory Submissions in Electronic Format —Certain Human...[more]

EMA releases revision 18 of the Dossier requirements for Centrally Authorised Products

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The European Medicines Agency (EMA) has released a new revision 18 of the "Dossier requirements for Centrally Authorised Products (CAPs)".

Revision 18, dated 08 May...[more]

EMA releases further updates to Procedural Advices for Users of the Centralized Procedure

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The European Medicines Agency has recently been very busy in producing updates to their "procedural advice for users of the centralised procedure". In April two updates,...[more]

CMDh releases updated submission requirements for MRP/DCP and national procedures

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The CMDh has released updated submission requirements (number and format) for applications within MRP, DCP and national procedures. The update concerns new applications and...[more]

National implementation of EU eSubmission roadmap - information from German BfArM and PEI


In line with the EU eSubmission roadmap that was adopted in November 2014, the German drug regulatory agencies BfArM and Paul Ehrlich Institute (PEI) have released corresponding...[more]

FDA revises example submission code using the new Module 1 version 2.3

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The FDA has released some some revised information related to the forthcoming new Module 1 version 2.3 which is targeted to come into effect in Q3 2015. The revision concerns the...[more]

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