Pharmaceutical legislation

CPME WG on Pharmaceuticals – Chairperson: Prof. Dr Wolf-Dieter LUDWIG (DE)

The revision of the legal framework governing medicinal products for human use in the EU should aim at improving standards to ensure a high level of public health protection and the quality, safety and efficacy of authorised medicines. The updated legislation should also ensure access to affordable medicines for patients and address unmet medical needs. Given that the public co-creates and is a major investor in health technologies, the EU should play a more active role in defining directions for health innovation to create a system that is aligned with medical and societal needs, rather than leaving it to be driven mainly by commercial interests.

The revision of Regulation 726/2004 and Directive 2001/83/EU provides a not to be missed opportunity to restore the balance in the pharmaceutical sector in the interest of patients and healthcare systems.

According to CPME, to achieve these goals, the revision should give priority to availability and affordability of medicines, more resilient supply chains, fit for purpose incentives to address unmet medical needs and safety and quality of medicines.

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Oct 2023 CPME 2023/101
CPME proposed amendments to the EU pharmaceutical legislation
Proposed amendments to the Commission’s Proposals for the Directive on the Union code relating to medicinal products for human use and the Regulation lying down Union procedures for the authorization and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency

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