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
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.
You may also be interested in...
EU Joint Regulatory Assessment Project Bears Fruit In COVID-19
The European Medicines Agency has reported progress with a collaborative project that involves other regulators in its assessments of COVID-19 products, and with the EU Medicines for All initiative for evaluating products for non-EU markets.
Takeda Test Drives EMA’s Parallel Review Route For EU And Non-EU Markets
A new evaluation route that the European Medicines Agency launched last year came at the right time for Takeda’s dengue vaccine candidate.
EMA Explains Procedure For Parallel Review Of Drugs For EU And Non-EU Markets
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.