In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more
4/23/2024
/ Clinical Trials ,
Data Protection ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
European Parliament ,
Marketing Authorization Application ,
Member State ,
Orphan Drugs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Amendments ,
Proposed Legislation ,
Regulatory Reform ,
Risk Assessment
We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the...more