Reform of the EU pharmaceutical legislation

Information on the upcoming changes introduced by the European Union's (EU) comprehensive overhaul of its pharmaceutical legislation.
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The European Parliament and the Council of the European Union have reached political agreement on the reform of the EU pharmaceutical legislation on 11 December 2025.

The text of the new pharmaceutical legislation and the changes it introduces will be fully detailed in 2026.

The new pharmaceutical legislation represents the most significant overhaul of the regulatory framework in over two decades. It will modernise how medicines are developed, authorised and made available to patients across the EU.

It covers medicines for human use throughout their lifecycle, from development support to safety monitoring. Key areas include support to innovation, the evaluation of medicines and structure of EMA’s scientific committees, paediatric and rare disease medicines, medicine shortages, and environmental sustainability.

The new pharmaceutical legislation is designed to:

  • Adapt the EU regulatory framework to support and foster innovation
  • Improve patient access to medicines
  • Address major public health challenges, including antimicrobial resistance (AMR)

EMA will provide regular updates regarding its implementation activities. Details will be available in the relevant areas of this website.

To find out more about EMA's work, see:

Key benefits

Select the expandable panels below to learn about the key benefits of the new pharmaceutical legislation:

Strategic priorities include:

  • Tackling antimicrobial resistance (AMR)
  • Supporting digitalisation
  • Fostering innovation,
  • Improving the availability of medicines

The European medicines agencies network strategy to 2028 is aligned with these priorities. 

For more information, see:

Reducing complexity for developers by streamlining structures and procedures that have accumulated through multiple legislative updates over the years.

Reducing administrative burden to:

  • strengthen the network's sustainability;
  • make more efficient use of scientific assessment resources;
  • and increase agility in evaluating complex products.

Modernising regulatory processes and improving efficiency by leveraging opportunities for digitalisation.

Implementation timeline

The adopted acts of the new pharmaceutical legislation are expected to enter into force in 2026.

The following two years, until 2028, will serve as a transition period. In this time interval, all EU Member States will need to update their national laws to align with the new rules.

In addition, the European Commission, EMA and EU Member States will provide implementation guidance to stakeholders.

Timeline

  1. December 2025

    Political agreement on new pharmaceutical legislation

  2. 2026

    Adopted acts of the new pharmaceutical legislation enter into force

  3. 2026-2028

    Transition phase

    -EU Member States update their national laws to reflect the new rules
    -European Commission adopts implementing and delegated acts to help implement the new rules
    -EMA and national competent authorities develop implementation guidance and adapt their procedures and IT systems

  4. 2028

    New pharmaceutical legislation becomes applicable

EMA's role

EMA will develop guidance for applicants and marketing authorisation holders, to help them comply with the new legal framework.

We will prepare this guidance in cooperation with the European medicines regulatory network and the European Commission.

EMA's Management Board adopted a governance structure to guide and oversee our implementation of the pharmaceutical legislation. A new group which includes representatives from EMA, its Management Board and the European Commission will oversee this work.

We will keep our stakeholders informed and actively involved in the implementation process on specific technical and procedural aspects. This will ensure the smooth implementation of the new pharmaceutical legislation.

For more information, see:

EMA activity areas on new pharmaceutical legislation

EMA's governance structure for the implementation of the new pharmaceutical legislation will oversee six related activities areas, or workstreams: 

  • Centralised procedure and committees
  • Development support
  • Environmental risks
  • Quality and manufacturing
  • Shortages
  • Regulatory and legal aspects 

EMA will provide details on these activity areas following the adoption of the new legislative text in 2026.

Background

The European Commission first proposed this comprehensive overhaul in April 2023.

The European Parliament adopted its position in April 2024 and the Council of the EU in June 2025. 

The new pharmaceutical legislation revises and replaces the following pieces of legislation:

In addition, the new legislation introduces a series of targeted amendments to the EU regulations: 

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