|Author (Corporate)||European Commission: DG Health and Food Safety|
|Series Details||COM (2023) 190|
Communication adopted by the European Commission on 26 April 2023, providing an overview to a proposed reform of the pharmaceutical legislation and proposed Council Recommendation on antimicrobial resistance (AMR).
The European Union's pharmaceutical legislation has for decades sought to set the highest standards of quality, safety and efficacy for the authorisation of medicines while promoting the functioning of the internal market and a competitive pharmaceutical industry. However, continuous transformation alongside health and geopolitical crises led to an understanding that action was required to modernise the existing framework.
In 2020, the European Commission adopted its Pharmaceutical Strategy for Europe, looking to create a future-proof and patient-centred pharmaceutical environment in which the EU industry can innovate , flourish, and reaffirm its position as a global leader. In this context, the Commission set out a revision of the EU's pharmaceutical legislative framework to achieve the following objectives:
The proposed reform drew on extensive consultations of relevant stakeholders. The legislative package includes:
|Subject Categories||Business and Industry, Culture, Education and Research, Health, Internal Markets|
|Subject Tags||Medicines | Medical Devices, Pharmaceuticals, Public Health|
|Keywords||Antimicrobial Resistance, Innovation
|International Organisations||European Union [EU]|