Recombinant and Human Plasma-derived Factor VIII Products
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or human plasma-derived factor VIII products is made for use in treatment and prevention of bleeding in patients with haemophilia A. The guidance covers clinical investigations to be conducted pre- and post-marketing authorisation. Guidance is also provided for authorised products where a significant change in the manufacturing process has been made.
For further details please see the "Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products".
Related GMP News
22.04.2026What are the GMP Requirements for ATMPs?
25.03.2026What are the GMP Requirements for Biotechnological Products?
18.03.2026Latest FDA Updates: Biosimilar Development Guidance
18.03.2026ECA ATMP Group publishes position paper on specifications considering patient-centricity
11.12.2025Utility of Comparative Efficacy Studies in Biosimilar Development
03.09.2025Standardisation of Monoclonal Antibodies (mAbs) by the EPC