HM1: Update on EU new regulatory legislation − EMA, industry and others


Olga Solomon highlighted the Commission proposals in relation to the reform of the EU pharmaceutical legislation, and notably the package adopted by the Commission in April 2023 which includes a new Regulation and a new Directive as well as an initiative aimed at preventing antimicrobial resistance (AMR). She reminded the session audience that the political objectives of this ambitious reform were to improve access to medicines in the EU, strengthen measures to prevent shortages of medicinal products and secure the supply of critical products, while reinforcing affordability for patients and ensuring environmental sustainability. These measures were prepared keeping in mind that they should not negatively impact the capacity of innovation of the pharmaceutical industry and maintain competitiveness.

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