GMP News - Blood / Biologics and ATMP

18.02.13

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.

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18.02.13

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.

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18.02.13

Plasma-derived Medicinal Products

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.

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