The European Commission recently launched a targeted stakeholder consultation on draft Guidelines on Good Manufacturing Practice for Advanced Therapy Medicinal Products, pursuant to Article 5 of Regulation 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC, that requires the Commission to draw up guidelines on good manufacturing practice specific to advanced therapy medicinal products. EIPG has reviewed the documents and. following feedback from its members, has submitted its comments to the Commission.
-
-
News from EIPG
- Annex 1 – a focus on its main issues (Webinar)
- How a pandemic has affected the pharma industry (Webinar)
- EIPG publishes updated version of Code of Practice for Qualified Persons
- Consultation on Annex 21: Importation of medicinal products, of the EudraLex Volume 4 (Webinar)
- The role of the body clock in drug development, efficacy and toxicity (Webinar)
- Medicines shortages: root causes and potential solutions
- GMP documentation management: requirements and best practices (Webinar)
