Reform of the EU pharmaceutical legislation

Information on the upcoming changes introduced by the European Union's (EU) comprehensive overhaul of its pharmaceutical legislation.
HumanVeterinaryInnovationMedicines

Polish is available via eTranslation, the European Commission's machine translation service.

Translate to Polish | Important information about machine translation

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 new pharmaceutical legislation (NPL). A new group which includes representatives from EMA, its Management Board and the European Commission will oversee this work.

Find more information on the NPL's governance structure under the 'Governance and activity areas' section on this page.

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:

Governance and activity areas

A governance structure is in place enabling the implementation of the new pharmaceutical legislation (NPL).

EMA, as part of the European medicines regulatory network, works within this governance structure. It ensures:

  • Coordination across activity areas
  • Informed and timely decision-making
  • Collaboration between EMA, the network, the European Commission and EU Members States
  • Strategic alignment between stakeholders

Find an EMA presentation on the implementation of the new pharmaceutical legislation under Related documents below. 

The image below shows an overview of the NPL governance structure:

Image - New pharmaceutical legislation: Governance structure overview

New pharmaceutical legislation governance structure overview

Implementation and stakeholder engagement will build on existing structures.

Execution will leverage established EU network groups, supplemented by ad hoc groups where gaps exist, and rely on current IT governance frameworks for deliverables.

Stakeholder engagement will take place via existing EMA platforms to connect with industry, healthcare professionals, and patients, ensuring coordination with NCAs and the European Commission.

  • New pharmaceutical legislation (NPL) oversight group - strategic direction and decisions
    • EMA programme management - coordination and implementation support
      • Delivery stream 1: Centralised procedures (CP) and committees - sponsors: EMA member, national competent authority (NCA) Management Board (MB) member, civil society MB member
      • Delivery stream 2: Development support - sponsors: EMA member, NCA MB member, civil society MB member
      • Delivery stream  3: Environmental risk assessment (ERA) and 3Rs (for ethical use of animals in medicine testing: replace, reduce, refine) - sponsors: EMA member, NCA MB member
      • Delivery stream 4: Quality and manufacturing - sponsors: EMA member, NCA MB member
      • Delivery stream 5: Shortages - sponsors: EMA member, NCA MB member
      • Delivery stream 6: Other regulatory and legal aspects - sponsors: EMA member, NCA MB member

Implementation and stakeholder engagement will build on existing structures.

Execution will leverage established EU network groups, supplemented by ad hoc groups where gaps exist, and rely on current IT governance frameworks for deliverables.

Stakeholder engagement will take place via existing EMA platforms to connect with industry, healthcare professionals, and patients, ensuring coordination with NCAs and the European Commission.

Oversight group

The NPL oversight group ensures alignment with EU priorities and oversees the implementation of the new pharmaceutical legislation.

It brings together:

  • representatives of the EMA Management Board;
  • representatives of the European Commission;
  • the representatives of the national competent authorities on EMA's Management Board;
  • EMA's senior leadership.

Programme management 

The programme management for NPL implementation supports coordination across the related activity areas, or delivery streams. 

Coordination includes the following:

  • Planning
  • Monitoring
  • Risk management
  • Reporting

Change management is embedded to support engagement, readiness and adoption across EMA and the European medicines regulatory network. 

Delivery streams 

Each of the six delivery streams focuses on implementing a specific area of the NPL. 

Delivery stream leads coordinate subject-matter experts and develop approaches to NPL implementation.

EMA leadership and national competent authority representatives on the EMA's Management Board co-sponsor the delivery streams.

Civil society representatives on EMA's Management Board can also co-sponsor delivery streams where relevant. 

They all work to implement the NPL under the strategic direction of the oversight group. 

For more information on NPL governance, see the 'New pharma legislation' presentation available via the following link: Industry Standing Group (ISG) meeting - Documents.

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: 

Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

26 June 2026

  • 'EMA activity areas on new pharmaceutical legislation' renamed and revamped as 'Governance and activity areas'
  • Content revamp includes a visual on the new pharmaceutical legislation governance structure overview and related information

15 January 2026

Page first published

Share this page