The European Commission recently launched a public consultation on a Commission Delegated Act on principles and guidelines on good manufacturing practice for investigational medicinal products and on inspection procedures, pursuant to the first subparagraph of Article 63(1) of Regulation (EU) No 536/2014 and Detailed Commission guidelines on good manufacturing practice for investigational medicinal products for human use, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014. EIPG has reviewed the documents and. following feedback from its members, has submitted its comments on the Commission.
Read the EIPG Feedback on the proposed Commission Delegated Act and GMP Guidelines.