News about GMP/cGMP


EC: Final Annex 2 for Manufacturing Biological Products

The European Commission has now published the final version of Annex 2 "Manufacture of Biological active substances and Medicinal Products for Human Use". It is in operation since 26 June 2018.

Annex 2 is no longer applicable to Advanced Therapy Medicinal Products to which now applies the Commission guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products. The separate guideline on ATMPs is listed under Part IV of Eudralex Volume 4 and entered into force on 22 May 2018.


European Commission