The political agreement on the reform of the pharmaceutical legislation reached on 11 December 2025 by the EU Council and Parliament comes after more than two years of intense negotiations.
Once finally adopted by the two institutions, the resulting framework will mark the complete restructuring of the European regulatory framework for the development, approval, and commercialisation of medicines after more than 20 years. The reform of the pharmaceutical legislation will comprehensively reshape the incentives for innovation, the regulatory pathways, and the measures for managing shortages, among other key issues, so as to enable the sector to better adapt to technical, societal, and political evolution.
We summarise the key elements of the agreement below. The new regulation and directive will replace the current legal framework for medicines for human use (Directive 2001/83/EC and Regulation 726/2004). It will also incorporate and update Regulation 141/2000 and Regulation 1901/2006 on rare and paediatric medicines, respectively. Targeted amendments will also be introduced to the ATMP Regulation (EU 1394/2007), the Clinical Trials Regulation (EU 536/2014), and the European Medicines Agency’s (EMA) extended mandate regulation (EU 2022/123).
The timeline for adoption and implementation
The new provisions of the pharmaceutical legislation shall enter into force in 2026, after formal adoption by the European Council and Parliament, which is expected early in the year (see the expected timeframe in the EMA’s website).
This should be followed by a two-year transition period (2026-2028), during which EU Member States will be required to update their national legislation, while the EU Commission will adopt the necessary implementing and delegated acts. The European Medicines Agency and the European Medicines Regulatory Network (EMRN) of national competent authorities (NCAs) shall also provide new implementation guidance and adapt their procedures and IT systems.
The new framework for IP protection and data exclusivity
The agreement sets the maximum combined protection for new pharmaceutical products at 11 years, using the 8+1(+1)(+1) formula. Regulatory data protection has been confirmed for 8 years (rather than the 6 years initially proposed by the Commission). An additional year of market protection has been granted (vs the current 2 years).
Several 12-month extensions to market exclusivity may apply to specific product categories. These include medicines for unmet medical needs, such asconditions for which there is no available medicinal treatment, or that bring exceptional therapeutic advancements. They also include new active substances for which comprehensive EU development has been conducted, and products containing a new active substance for which comparative clinical trials and clinical trials have been conducted in several EU Member States, provided that an application for marketing authorisation (MA) is submitted within 90 days of the first submission outside the EU. A 12-month incentive shall also be available for the authorisation of new therapeutic indications that bring significant clinical benefits compared to existing therapies.
Orphan and paediatric medicines
According to the agreement, orphan medicines shall be granted 9 years of market exclusivity. The new class of breakthrough orphan medicinal products shall refer to orphan medicines that address a disease for which there is currently no available medicinal treatment and that satisfy various requirements. These products may be granted up to 11 years of market exclusivity. The European Medicines Agency shall create and manage a new public register of designated orphan medicinal products.
The EU Commission shall no longer be responsible for granting or refusing orphan designations; this role shall be assumed by the EMA’sCHMP committee. The EMA will also provide early regulatory guidance before the submission of an application for marketing authorisation (MAA) for orphan products.
As for paediatric medicines, the approved package will incorporate paediatric requirements into the core regulatory framework, thereby improving the efficiency of the paediatric assessment process. Compulsory paediatric investigation plans (PIPs) shall also be introduced.
Expansion of the Bolar exemption
The Trilogue agreement supports faster market entry for generics and biosimilars by clarifying and expanding the Bolar exemption. Once finally adopted, according to the new pharmaceutical reform, IP rights and supplementary protection certificates (SPCs) will not be infringed if studies, trials, and activities conducted by the off-patent industry are carried out to obtain MAs or pricing and reimbursement approvals, to conduct HTA assessments, or to submit procurement tender applications.
The new provisions are expected to enable generic and biosimilar manufacturers to carry out all the necessary preparatory activities during the original product’s protection period, so as to be ready for the day-1 launch of their versions at the expiry of patents and SPCs. Companies shall also be entitled to participate in procurement tenders before the end of the market exclusivity period, provided that products can only be sold after expiration of the exclusivity.
Regulatory simplification and efficiency
Another main objective of the reform is to reduce the administrative burden and accelerate patient access by simplifying regulatory procedures. The EMA’s extended mandate will be revised. Its new governance structure shall oversee six areas of activity, i.e., centralised procedure and committees, support to product development, environmental risks, quality and manufacturing, shortages, and regulatory and legal aspects.
EMA’s internal organisation shall also be revised, with only two scientific committees for human medicines remaining: the Committee for Human Medicinal Products (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC). The other current committees will be replaced by expert advisory groups.
Streamlined regulatory procedures shall include submission of an MAA in a common electronic format. Once granted, marketing authorisations shall be valid indefinitely unless safety concerns necessitate a time-limited authorisation. The pharmaceutical package shall also include a reduced timeline for the issuing of CHMP scientific opinions and streamlined amendment and variation procedures.
Package leaflets may be made available in paper or electronic format. Member States may opt for an electronic-only format for some or all medicinal products, following a consultation with the interested parties.
The EU Commission may establish regulatory sandboxes, overseen by the relevant competent authorities, to support the development and testing of innovative therapies that do not fit within existing frameworks. Adapted regulatory pathways could also be activated for non-standard categories, such as personalised therapies.
Measures to manage shortages and supply security
The management of medicine shortages was one of the critical issues that the reform of the pharmaceutical legislation aimed to address.
The reached agreement introduces an obligation to supply for marketing authorisation holders (MAHs). Member States may require companies to supply adequate quantities of products covered by regulatory data and market protection in order to meet patient needs. If the products are not launched within the specified timeframe (unless exceptional circumstances that are beyond the company’s control), the MAHs may lose market protection for the interested medicine, allowing earlier generic entry into the market.
MAHs shall also be required to develop and maintain shortage prevention plans for prescription medicines and other products identified by the Commission. These plans shall be regularly updated and shall be subject to regulatory review. MAHs shall also compulsorily notify the competent authorities of any market cessation, withdrawal, temporary suspensions, or disruptions.
The adoption of proactive measures shall be supported by the creation of early warning systems. In particular, both NCAs and the EMA shall monitor expected and actual shortages based on the notifications received. The EMA shall also establish and maintain a list of critical shortages in the EU, so as to better support a coordinated response.
Activation of the Voluntary Solidarity Mechanism for Medicines can be requested by Member States, on a voluntary basis and as a last resort, provided that certain conditions are met. The Mechanism shall be coordinated by the MSSG and supported by the EMA.
The Union List of Critical Medicines
The Union list of critical medicines was first published in December 2023 by the EU Commission, the EMA, and the Heads of Medicines Agencies (HMA). The most recent version dates from December 2025. The current list contains approx. 2,200 substance groups and combinations, covering around 75% of authorised medicinal products in the EU – including both innovative and generic medicines – across a variety of therapeutic areas.
According to the agreement, each Member State shall identify critical medicines, upon consultation with healthcare professionals and patient organisations. The EMA and the Medicine Shortages Steering Group (MSSG) shall jointly develop a common methodology for such identification. The MSSG shall also propose updates to the Union list based on progress in evaluating the vulnerability of supply chains.
Environmental and antimicrobial measures
The introduction of the Transferable Exclusivity Vouchers (TEVs) to support the development of new antimicrobial medicines has been confirmed. The voucher will provide 12 months of additional data protection for the new antimicrobial agent or another centrally authorised medicinal product. TEVs may only be used once for products with annual gross sales of more than € 490 million over the previous four years.
Furthermore, according to the agreement, all antimicrobials shall be prescribed to prevent unnecessary use. Member States may impose further limitations, for example, with regard to the quantities prescribed, the validity of the medical prescription, or the need for a special medical prescription or restricted prescription.
For direct patient dispensing, the pack size of the antimicrobial medicine should correspond to the standard dosage and treatment duration. If the package leaflet is available only in electronic format, an “awareness card” in paper format should be made available to patients. Any new MA application for an antimicrobial agent shall also contain an antimicrobial stewardship plan.
A compulsory Environmental Risk Assessment (ERA) shall be submitted for every new MAA to evaluate the risks posed by the possible release of the product into the environment. The plan shall also identify risk mitigation measures to address pharmaceutical residues in water and soil, paying special attention to the presence of persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent and very mobile (vPvM), and endocrine-active agents. ERAs for antimicrobials shall also evaluate the risk for resistance selection in the environment throughout the entire manufacturing supply chain. An incomplete or insufficiently substantiated ERA may result in refusal of the MA.
Joint procurement of antimicrobials and public funding of R&D
Joint procurement may be requested by different Member States for the purchase of antimicrobials and based on a multi-year subscription, those relevant components should be identified by the Commission and Member States.
Direct public funding for R&D activities received by MAHs, irrespective of legal entities or geographic location, shall be declared for each medicinal product covered by a national or a centralised marketing authorisation.
