EU Approves the Most Extensive Pharmaceutical Legislation Reform in 20 Years

The European Parliament and the Council of the European Union have reached a final political agreement on the comprehensive reform of the EU pharmaceutical legislation. According to the European Medicines Agency (EMA), this marks the most significant overhaul of the European pharmaceutical industry’s regulatory framework in over two decades. The new rules are expected to enter into force in 2026.

Essence and Main Goals of the Reform

The approved package of documents aims to modernize the development, authorization, and market launch processes for human medicines. The reform covers the entire lifecycle of medicines — from research support to post-marketing safety monitoring.

The key priorities of the new legislation are:

• Stimulating innovation: adapting the regulatory framework for the accelerated introduction of advanced developments;
• Combating global threats: addressing the issue of antimicrobial resistance (AMR);
• Treatment accessibility: improving patient access to necessary medicines and systematically combating drug shortages;
• Environmental care: implementing requirements for the environmental sustainability of production and environmental risk assessment;
• Special categories: updating the rules for developing orphan drugs and paediatric medicines.

Reducing Administrative Burden and Digitalisation

The new reform aims to significantly reduce the administrative burden on businesses by eliminating procedural complexities that have accumulated through numerous legislative amendments over the years.

This is expected to increase the sustainability of the European regulatory network, allow for more efficient use of resources for scientific assessment, and ensure flexibility in evaluating complex innovative products. A crucial tool in achieving this efficiency will be the large-scale digitalisation of regulatory processes.

As part of the reform, the foundational documents regulating the circulation of medicines (Regulation (EC) No 726/2004 and Directive 2001/83/EC) will be replaced, and targeted amendments will be made to the rules for clinical trials and advanced therapy medicinal products (ATMPs).

Roadmap and Transition Period

The political agreements on the reform were finalized on December 11, 2025 (earlier, in April 2023, the European Commission first proposed the reform draft, the European Parliament adopted its position in April 2024, and the Council of the EU in June 2025).

The further implementation schedule is as follows:

• 2026: Official entry into force of the adopted acts and publication of the final texts of the new laws;
• 2026–2028 (Transition Period): Updating the national laws of EU Member States. During this period, the European Commission, EMA, and national authorities will develop detailed guidelines for businesses and adapt their IT systems;
• 2028: The new pharmaceutical legislation will become fully applicable across the European Union.

The Role of the European Medicines Agency (EMA)

To ensure a smooth transition, the EMA, together with the European Commission, will develop detailed instructions for applicants and marketing authorisation holders. The EMA Management Board has already approved the governance structure for implementing the reform, identifying six main activity areas (workstreams):

1. Centralised procedure and committees;
2. Development support;
3. Environmental risks;
4. Quality and manufacturing;
5. Shortages;
6. Regulatory and legal aspects.

The EMA emphasizes its plans to actively involve stakeholders in discussing technical and procedural nuances to ensure the successful adaptation of the European pharmaceutical market to the new realities.

Chronology and Implementation Stages of the Reform