The European Commission has announced on 26 April 2023 its proposals for the revision of the pharmaceutical legislation. The package is comprehensive of a Directive, a Regulation and a Council Recommendation on antibiotic resistance; it will now undergo scrutiny by the EU Parliament and Council before adoption and entry into force. The objective of the EU Commission is to create a Single Market for medicines in the EU. Among major proposals, pharmaceutical companies should benefit of a 2 years extension of the market protection in case they launch a new product in all Member States at the same time. Incentives are also planned for medicines for rare diseases, unmet medical needs, comparative clinical trials, or new therapeutic indications. The standard period of regulatory protection would be 8 years, extending up to 12 years with the incentives (13 for rare diseases).
Simplification of the regulatory framework should reduce the maximum time to evaluate a dossier to 180 days, thanks also to electronic submissions. New procedures are planned to speed up approval of generics and biosimilars. Renewal of marketing authorisations should be abolished in many cases. Shortages and repurposing of medicines already on the market are also addressed. The EU Commission also supports a higher sustainability of pharmaceutical products in line with the objectives of the European Green Deal, to be tackled by stricter environmental risk assessment and measures to fight antimicrobial resistance.
Source: European Commission