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EMA Explains Procedure For Parallel Review Of Drugs For EU And Non-EU Markets

 
• By Vibha Sharma

Companies can get the European Medicines Agency’s scientific opinion for their products’ use in EU and non-EU countries at about the same time.

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The EU-M4all procedure aims to facilitate medicines access in non-EU countries • Source: Shutterstock

The European Medicines Agency has issued new guidance for companies interested in applying for the parallel evaluation of their medicines or vaccines meant for the EU-wide market as well as for non-EU countries under the so-called Article 58 procedure.

The parallel assessment would result in the EMA’s human medicines evaluation committee, the CHMP, adopting a scientific opinion in relation...

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