The European Commission recently launched a targeted stakeholders consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of the Eudralex Volume 4. EIPG has reviewed the document and, following feedback from its members, has submitted its comments to the EMA.
News from EIPG
- Content and format of ANDA submissions June 13, 2019
- Quality requirements for drug-device combinations June 8, 2019
- Developing drugs for treatment of nonalcoholic steatohepatitis June 8, 2019
- Enhancing the diversity of clinical trial popoulations June 8, 2019
- Development of therapeutic protein biosimilars May 22, 2019