Our colleagues have published the outcome of a survey of European Federation of Pharmaceutical Industries and Associations (EFPIA), The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and The European Association for Bioindustries (EuropaBio) members. The survey was conducted last year to assess industry experiences submitting national GMO applications after the implementation of the clinical trials regulation (CTR) on January 31, 2022. The outcome of the survey helps identify some areas of the CTR and GMO submissions where additional regulatory harmonisation is required in the EU and where other areas of procedural and regulatory improvement are highlighted.
