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EMA Offers Simultaneous Review Of Products For EU And Non-EU Markets

Move Will Reduce Time For Article 58 Opinion On Medicines To Be Also Used In EU

 
• By Vibha Sharma

Companies can have their EU centralized marketing authorization application and submission for an Article 58 opinion (on medicines for use in non-EU countries) reviewed in parallel by the European Medicines Agency. The simultaneous assessment can be helpful when drugs and vaccines are needed for both EU and non-EU populations.

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Parallel Review Possible For Products Seeking EU-Wide Approval & Article 58 Opinion • Source: Shutterstock

The European Medicines Agency is offering companies the possibility to apply for the parallel assessment of medicines or vaccines meant for the EU-wide market as well as for non-EU countries under the so-called Article 58 procedure.

The simultaneous assessment of EU centralized marketing authorization applications (MAAs) and Article 58 submissions, the EMA explained, will help optimize the use of national competent authority resources, prevent assessment discrepancies between the two submissions, and reduce the time

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