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Focus on Regulation

Tag Archives: marketing authorisation

EMA publishes draft Guideline on clinical investigation of haemophilia B medicinal products

Introduction The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products.[1] The purpose of this guideline is to provide applicants and regulators with harmonised requirements for applications for marketing authorisation of haemophilia B medicinal products. In July, a similar guideline was adopted concerning haemophilia A medicinal products.

The European Medicines Agency adopts new guidance on Adaptive Pathways

The European Medicines Agency (“EMA”) has published a new guidance document for companies that wish to participate in the Adaptive Pathways initiative (“New Guidance”). Adaptive Pathways Adaptive Pathways was established as part of the EMA’s objective to improve timely access for patients to new medicinal products. Adaptive Pathways applies to medicinal products with the potential