What changed in the EU framework for medicines
EU rules on medicines and the strategies of the European medicines regulatory network change: an overhaul of the EU pharmaceutical legislation was agreed in December 2025, the network drew lessons from its response to COVID-19, and multi-year strategies set the network's direction, from the European Medicines Agency's road map to 2015 to the joint network strategy to 2028.
The overhaul of the pharmaceutical legislation
On 11 December 2025 the European Commission, the European Parliament and the Council of the European Union reached a political agreement on a comprehensive reform of the EU pharmaceutical legislation. The European Medicines Agency (EMA) calls it the most significant overhaul of the regulatory framework in over two decades and a once-in-a-generation opportunity to reshape medicines regulation in the EU. The new legislation will modernise how medicines are developed, authorised and made available to patients across the EU. It is expected to simplify structures and procedures introduced over the years by the existing pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC) and by the legislation on medicines for children and for rare diseases (Regulation 1901/2006 and Regulation 141/2000 respectively), and it amends the advanced therapy medicinal products Regulation 1394/2007. The reform affects the following key areas.
A simpler regulatory environment
- The agency will simplify its committee structure from five scientific committees for human medicines to two, the Committee for Human Medicinal Products (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC). The leaner structure will be complemented by stronger support for the two committees through the best available expertise, and the committees will benefit from increased patient and healthcare professional representation.
- The streamlined structure facilitates a shorter assessment time, 180 days instead of 210, and frees up scientific resources to strengthen pre-authorisation support to medicine developers.
- A marketing authorisation will be valid by default for an unlimited period, avoiding the unnecessary administrative burden of renewals unless the agency's scientific committees require them on safety grounds.
- Applicants will be required to submit marketing authorisation applications in electronic and structured formats and to make approved product information available in electronic form (ePI).
Support for innovation
- The agency may offer extended scientific advice together with health technology assessment bodies or medical device expert panels, and strengthened PRIME support.
- The Commission may establish, at the agency's suggestion and in consultation with member states, a regulatory sandbox to test, under the direct supervision of the competent authorities, adapted requirements for innovative medicines that cannot be developed under current rules.
- Adapted frameworks are to be created for certain non-standard categories of medicines, such as personalised therapies, that can provide a major contribution to patient access or patient care.
- The process for studying medicines in children is to become more efficient, including by formalising a new process for iterative paediatric investigation plans (PIPs) that the agency has already piloted.
Supply of medicines and shortages
- Companies will have stronger obligations to ensure the continuous supply of medicines.
- Companies will be obliged to notify shortages and withdrawals in advance and to have shortage prevention plans in place for prescription medicines.
- The agency and the national competent authorities will monitor expected and actual shortages, based on notifications from marketing authorisation holders.
- An EU list of critical medicines will be established, and supply chain vulnerability assessments will be carried out for the medicines on it.
Environmental protection and antimicrobial resistance
- Environmental protection is enhanced through environmental risk assessment, including special methodologies to evaluate the risk of antimicrobial resistance selection in the environment due to the manufacture of antimicrobials.
- Measures for the prudent use of antimicrobials include compulsory medical prescriptions for all antimicrobials, specific information requirements for the package leaflet, an awareness card and an antimicrobial stewardship plan to be submitted by applicants.
Formal approval and implementation
When it was reached, the political agreement remained subject to formal approval by the European Parliament and the Council. Once the text is formally approved, the agency will work with the Commission and the member states over the following months and years to develop guidance that helps applicants and marketing authorisation holders comply with the new legal framework. The agency's stakeholders will be kept informed and actively involved in implementing the specific technical and procedural aspects of the reform. The agency plans to publish a new web page as a gateway and central repository of information on implementing the new legislation, to be updated as implementation work progresses and guidance for pharmaceutical companies becomes available.
Lessons from the COVID-19 response
A joint report of the agency and the Heads of Medicines Agencies (HMA), updated on 1 December 2023, reviews the European medicines regulatory network's response to COVID-19 and highlights the main lessons for any future health crises. The network was at the forefront of the fight against COVID-19 through its crucial role in evaluating and monitoring medicines, including vaccines. The review highlights some of the unprecedented challenges that had to be addressed and the activities and areas that enabled the effective response to the emergency, and it recommends the improvements that are needed.
Accelerated procedures for evaluating COVID-19 vaccines and therapeutics, and scientific recommendations on the use of certain medicines, enabled the public health response through safe and effective prevention and treatment options. Collaboration between EU and international partners was crucial to ensure that regulators around the world adopted a coordinated approach to COVID-19 treatments and vaccines. The network pooled its resources to address the increased workload and new tasks such as managing medicine shortages, generating evidence on COVID-19 medicines in the real-world setting, and regularly providing reliable, science-based information to the public. The EU safety monitoring and risk management system was strengthened to collect and monitor the high volume of data from the mass vaccination campaigns, which allowed the network to identify, assess and manage safety issues promptly. Throughout the crisis, medicines for other diseases affecting Europeans continued to be evaluated and supervised without delays.
The report suggests that more can be done to set up large clinical studies rapidly. For real-world data, it finds a need to gather multiple data sources that can generate useful evidence for regulatory assessments. It acknowledges the need for a larger pool of experts who can be involved in scientific assessments, such as accelerated reviews of promising medicines, when crisis situations arise.
The agency's Management Board adopted the report. By then several of the report's recommendations had been implemented as part of the agency's extended mandate, under which the agency took on an enhanced role in preparedness to be more proactive on public health threats. The HMA and the agency continued to work closely on areas such as resourcing, process improvements and communication. The review of the EU pharmaceutical legislation then under way was to provide a vehicle for other changes to the EU regulatory toolbox, and the recommendations were to be considered in future updates of the network's strategy.
The network's strategies
The road map to 2015
At the end of 2010 the European Medicines Agency published a road map setting out a strategic vision for its operation from 2011 to 2015, around three strategic areas where much of its effort would be spent: addressing public health needs, facilitating access to medicines, and optimising the safe and rational use of medicines. A follow-up document explained how the agency would go about achieving its goals in each area, and recognised that the difficult economic situation would affect the availability of resources and the achievement of the stated goals.
The road map committed the agency to focus on increasing its role as an information provider and on greater collaboration with health technology assessment processes, the bodies responsible for determining cost-effectiveness, such as the UK's National Institute of Clinical Excellence. One regulatory writer notes that regulators generally assess efficacy, and holds that even without a broader remit the health authorities hold information that could be useful to health authorities and other payers in making their decisions, and that this information could be made more readily available without redesigning the whole process.
The road map also committed the agency to improve its focus on the needs of geriatric patients. One regulatory writer takes this commitment as recognition that patients over 65 years are often excluded from clinical trials, for example because they take several medicines, although they form a sizeable portion of the users of many medicines, such as hypertension therapies. The writer holds that changes of this kind, if they occur, will bring regulatory approval closer to real life.
On antibiotic resistance, the road map committed the agency to encourage pharmaceutical companies by reviewing existing options to promote the development of new antibiotics to treat multi-resistant bacteria, including adaptation of clinical guidance documents, consideration of the balance between the amount of prior data needed and enhanced post-marketing surveillance, and use of orphan legislation. One regulatory writer finds the commitment somewhat vague, and holds that its general idea seems to be to reconsider the burden of proof before approval, as with orphan products, while paying close attention to the medicine once it is on the market. The writer finds it unclear whether the reference to orphan legislation also takes in the financial incentives associated with those products, such as access to scientific advice and exclusivity.
The network strategy to 2028
In March 2025 the European Medicines Agency and the Heads of Medicines Agencies published their joint EU medicines agencies' network strategy to 2028, "Seizing opportunities in a changing medicines landscape", following its adoption by the Heads of Medicines Agencies and the agency's Management Board. It is a comprehensive update of the five-year strategy that covered 2021 to 2025, and it is to guide the network in meeting the challenges ahead, including preparing for and responding to public health emergencies and threats such as antimicrobial resistance. Prepared in a post-pandemic setting, it draws on the experience of tackling COVID-19, and it takes into account the then ongoing revision of the EU's pharmaceutical legislation, laying the groundwork for its implementation.
Its six focus areas build on those of the strategy to 2025, with more emphasis on the EU's competitiveness in the development and manufacture of medicines and on the use of artificial intelligence throughout a medicine's lifecycle. The six focus areas are:
- Accessibility, to facilitate pathways for access to medicines through healthcare systems in the EU.
- Leveraging data, digitalisation and artificial intelligence, to improve decision making, optimise processes and increase efficiency.
- Regulatory science, innovation and competitiveness, to create a regulatory and research environment that accelerates the translation of innovation and improves the competitiveness of the EU's healthcare sector.
- Antimicrobial resistance and other health threats, to prepare the EU for potential threats including antimicrobial resistance.
- Availability and supply, to strengthen the availability of medicines to protect public and animal health.
- Sustainability of the network, to ensure that the network has the resources to support its scientific and regulatory decision making, taking full advantage of technological advances.
It introduces the One Health approach as a key aspect, recognising that the health of humans, animals and the wider environment are closely intertwined.
The strategy was developed with experts and stakeholders across the network: a public consultation in late 2024 drew 77 submissions that helped shape it, and in February 2025 the agency and the Heads of Medicines Agencies, in partnership with the Polish EU presidency, held a webinar with stakeholders to further refine and finalise the text. The final strategy is published with an overview of the comments received during the consultation. The agency and the Heads of Medicines Agencies will implement it through their respective multi-annual workplans and at national level, and the network will monitor its implementation, report back and adjust as needed.