Recombinant and Human Plasma-derived Factor IX Products
In February 2012 the "Guideline on clinical investigation of recombinant and human plasma-derived factor IX products" came into effect. The purpose of this guideline is to provide applicants and regulators with harmonised requirements for applications for marketing authorisation for recombinant or plasma-derived factor IX products. More can be found here.
Recombinant and Human Plasma-derived Factor VIII Products
The purpose of this guideline is to provide applicants and regulators with harmonised requirements for applications for marketing authorisation for recombinant or plasma-derived factor VIII products. Find out more.
Providing guidance for the collection of starting material, the manufacturing and the quality control of plasma-derived medicinal products the "Guideline on plasma-derived medicinal products" became effective in 2012. Read on here.