European Commission Proposal of April 26, 2023 laying down Union procedures for the authorisation and supervision of medical products

Patient access to medicinal products across the EU and security of supply are growing concerns. There is also a growing problem of shortages of medicinal products for many EU/EEA countries. Consequences of such shortages include decreased quality of treatment received by patients and increased burden on health systems and on healthcare professionals, who need to identify and provide alternative treatments. While the pharmaceutical legislation creates regulatory incentives for innovation and regulatory tools to support timely authorisation of innovative and promising therapies, these products do not always reach the patient, and patients in the EU have differing levels of access.

The proposal of a new regulation European Commission has the following objectives:

General objectives:

– guarantee a high level of public health by ensuring the quality, safety and efficacy of medicinal products for EU patients;

– harmonise the internal market for the supervision and control of medicinal products and the rights and duties incumbent upon the competent authorities of the Member States.

Specific objectives;

– make sure all patients across the EU have timely and equitable access to safe, effective, and affordable medicines; – enhance security of supply and ensure medicines are always available to patients, regardless of where they live in the EU;

– offer an attractive innovation-and competitiveness friendly environment for research, development, and production of medicines in Europe;

– make medicines more environmentally sustainable.

This proposal of April 26th,2023 still has to be approved by the European Parliament and the Council. Amendments still can be made.

Nevertheless, the proposal shows above all, how the European Commission wants to tackle the problem of shortages of medicines in the EU.

The European Commission wants to focus on notification of possible shortages by market players and the use of generic drugs.

You can find the European Commission's proposal here

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