European Commission Publishes Proposals To Revise Current EU Pharmaceutical Legislative Framework

Yesterday, the European Commission published two legislative proposals concerning the regulation of medicinal products in the European Union. The proposals seek to consolidate existing legislation into two instruments, a revised and amplified version of Directive 2001/83, the Community code on medicinal products, and a revised and amplified version of Regulation 726/2004, the European Medicines Agency (EMA) Regulation. The proposals include a draft regulation laying down EU procedures for the authorisation and supervision of medicinal products for human use and creation of rules governing the EMA and a draft directive relating to medicinal products for human use. The European Commission also proposed a Council Recommendation on antimicrobial resistance.