The European Commission, the European Parliament, and the Council of the European Union, have agreed to a proposal for the EU’s landmark pharma legislation, setting the stage for major reforms.

By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org

Major reforms to EU’s pharmaceutical legislation
Policymakers in the European Union (EU) took a significant step forward this week (December 11, 2025) in advancing major reforms to the EU’s regulatory framework, representing the most significant overhaul of the regulatory framework of pharmaceuticals in the EU in over two decades. The landmark political agreement reached by the European Commission, the European Parliament, and the Council of the European Union, seeks to boost competitiveness, innovation, and security of medicines supply.

The reforms to the EU’s pharmaceutical legislation was first proposed by the European Commission in April 2023. The European Parliament adopted its position in April 2024, and the Council of the European Union in June 2025. The political agreement is now subject to formal approval by the European Parliament and the Council of the European Union.

Regulatory data and market protection
Key for both innovator and generics/biosimilars companies are proposed measures for data protection exclusivity. The proposed measures set a regulatory data protection period (during which other companies cannot access product data) of eight years, with one additional year of market protection (during which generic or biosimilar products cannot be sold) following a marketing authorization. Pharmaceutical companies would be eligible for additional periods of market protection under certain conditions. If the particular product addresses an unmet medical need, an additional 12 months of exclusivity would be granted. Also, an additional 12 months of exclusivity would be granted if the product contains a new active substance and meets a combination of conditions on comparative clinical trials, clinical trials carried out in several EU member states, and the obligation to apply for market authorization within 90 days after the submission of the application for the first marketing authorization outside the Union. In addition, if a company obtains an authorization for one or more new therapeutic indications that bring a significant clinical benefit in comparison with existing therapies, an additional 12 months of exclusivity would be granted. .

In addition, the proposed measures envisage a cap of 11 years on the combined regulatory protection period. Orphan medicinal products addressing a disease with no current available medicinal treatment (“breakthrough orphan medicinal products”) would receive up to 11 years of market exclusivity.

To support earlier market entry of generic and biosimilar medicinal products, the deal clarifies the scope of the “Bolar” exemption (which allows manufacturers to conduct certain activities during the market protection period of the original product). The proposed measures specify that patent rights would not be infringed when necessary studies, trials, and other activities are conducted for the purposes of obtaining marketing authorizations, conducting health technology assessments, obtaining pricing and reimbursement approvals, or submitting procurement tender applications.

Supply chain and drug shortages
The proposed reforms also establish several new rules for marketing authorization holders and public health authorities to cooperate to ensure continuity of supply and availability of critical medicines in the EU. Companies holding marketing authorizations for medicinal products would be required to put in place and update shortage prevention plans for medicinal products identified by the European Commission. Expected and actual drug shortages would be monitored at both national and EU levels, based on notifications from marketing authorization holders. The proposed measures also call for the establishment of an EU list of critical medicines for which supply-chain vulnerability assessments will be required to be carried out by pharmaceutical companies.

Simplifying the drug review process
Under the proposed reforms, the European Medicines Agency (EMA), the EU regulatory body for pharmaceuticals, would put into place several measures to streamline the drug review process. The updated rules would simplify EMA’s internal functioning to enable it to treat market authorization requests more rapidly. Marketing authorization applications would be submitted electronically in a common format. Marketing authorization for a medicinal product would be valid by default for an unlimited period, avoiding the unnecessary administrative burden linked to renewals (the EMA would still have the possibility to limit validity, on safety grounds). Under special conditions, the European Commission may set up regulatory sandboxes, under the direct supervision of the competent authorities, to allow the development and testing of new and innovative therapies that cannot by developed under current rules,. Such a regulatory sandbox would be established at the suggestion of EMA and in consultation with EU member states.

Also, under the proposed measures, EMA would simplify its committee structure from five to two scientific committees, the Committee for Human Medicinal Products and the Pharmacovigilance Risk Assessment Committee. The streamlined structure is intended to facilitate reduced assessment times from 210 to 180 days and free up scientific resources to strengthen pre-authorization support to medicine developers.

The proposed measures also support the creation of adapted frameworks for certain non-standard categories of medicines, such as personalized therapies, and provide further support for pediatric drug development. The proposed measures specify improvements in the efficiency of the process for studying medicines in children, including formalizing a new process for iterative pediatric investigation plans (PIPs) already piloted by EMA.

Enhanced environmental protection and focus on antimicrobial resistance
The proposed legislation also strengthens provisions relating to environmental risk assessment, including special methodologies to evaluate the risk for antimicrobial resistance selection in the environment due to the manufacture of antimicrobials.

Among new measures to promote the prudent use of antimicrobials, the proposed legislation introduces stricter requirements, such as compulsory medical prescriptions for all antimicrobials, specific information requirements to be provided with the package leaflet, and an “awareness card” in paper format in case the leaflet is made available only electronically.

The proposed legislation also includes measures to encourage the development of antimicrobials by introducing a “transferable data exclusivity voucher” for priority antimicrobials, giving the right to 12 additional months of data protection for one authorized product. The 12-month extension may be used once, for the priority antimicrobial or for another centrally authorized medicinal product of the same or different marketing authorization holder. When applying for marketing authorization for antimicrobials, companies would also need to provide an “antimicrobial stewardship plan” and include an evaluation of the risk for antimicrobial resistance as part of the compulsory environmental risk assessment.

Next steps
The provisional agreement is now subject to formal approval by the European Parliament and the Council of the European Union. Once the text of the proposed EU pharmaceutical legislation is formally approved, over the coming months and years (as reported on December 11, 2025), EMA will work together with the European Commission and EU member states to develop relevant guidance for applicants and marketing authorization holders to comply with the new legal framework.

To ensure the smooth implementation of the legislation, EMA says its stakeholders will be kept informed and actively involved in the implementation process on specific technical and procedural aspects of the reform. EMA plans to publish a new web page that will serve as a gateway and central repository of information on implementation of the new legislation. The webpage will be updated as implementation work progresses and guidance for pharmaceutical companies becomes available.