Introduction The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products. 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.
On 26 October 2018, the European Medicines Agency (EMA), advised marketing authorisation holders to submit type I variations prior to the temporary closure of the EMA. The EMA will relocate from London to Amsterdam and will be closed between 21 December and 2 January 2019.
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