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.
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A new evaluation route that the European Medicines Agency launched last year came at the right time for Takeda’s dengue vaccine candidate.
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.
Switzerland’s medicines agency has cleared Ferring’s carbetocin for preventing uterine haemorrhage under the Marketing Authorization for Global Health Products (MAGHP) procedure, which is intended to accelerate the approval of new products in low- and middle-income countries.