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.
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News from EIPG
- European Council’s conclusions on the European Innovation Agenda and research infrastructures
- EMA’s new Quality Innovation Expert Group (QIG)
- ICMRA report on best practices against antimicrobial resistance
- New steps towards the activation of the Unified Patent Court
- Comments to the draft ICH guidelines Q2(R2) and ICH Q14
- A concept paper on the revision of Annex 11
- What happens after IP loss of protection