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The European Bolar exemption is a legal provision that allows pharmaceutical companies to conduct research and testing on patented drugs without being considered as infringing the patent. This exemption is particularly relevant for the development of generic and biosimilar medicines.

The Joint Scientific Consultation framework is a core component of European Union Regulation (EU) 2021/2282 on health technology assessment, through which health technology developers can discuss planned evidence generation with a subgroup of the Member State Coordination Group on Health Technology Assessment and receive non-binding scientific recommendations intended to inform a later Joint Clinical Assessment.

The European Union (EU) operates a set of research and innovation (R&I) programmes that provide indirect but substantial incentives for the development of innovative medicines.

EURIPID is a voluntary, not-for-profit collaboration of national authorities responsible for pricing and reimbursement that share standardised information on official prices of publicly reimbursed medicines.

Following the European Council’s publication of its position on the proposed update to the European pharmaceutical legislation in June 2025, further discussions are ongoing with publication expected during 2026

Europe’s pharmaceutical regulatory system unites national authorities and the European Medicines Agency to ensure that only safe, effective, and high-quality medicines reach patients through coordinated approval and monitoring processes.

The Heads of Medicines Agencies (HMA) is a collaborative network comprising the heads of National Competent Authorities (NCAs) responsible for regulating medicinal products for human and veterinary use within the European Economic Area (EEA).

The European Union is currently undertaking a significant revision of its pharmaceutical legislation with the overarching goals of ensuring timely and equitable access to safe, effective, and affordable medicines for all patients across the EU, enhancing the security of the supply of medicines, maintaining an environment conducive to pharmaceutical research and development, improving the environmental sustainability of medicines, and addressing antimicrobial resistance.

The Joint Clinical Assessment (JCA) is the European Union’s centralised evaluation of comparative clinical effects and safety for selected health technologies. It started to apply on 12 January 2025 under the EU Health Technology Assessment framework to address widespread duplication of national clinical assessments, improve methodological consistency across Member States, and provide a single clinical evidence base to support more efficient national decision-making.

Each European Union (EU) member state maintains its own national authority for oversight of medicines’ safety and efficacy. These bodies collaborate with the European Medicines Agency (EMA), which leads assessments and coordinates procedures across the EU. This Briefing summarises the respective roles of national and European regulators.

Parallel scientific advice between the European Medicines Agency (EMA) and health technology assessment (HTA) bodies is a voluntary process that allows medicine developers to obtain coordinated, non-binding feedback on evidence-generation plans. It is intended to align regulatory benefit–risk requirements with HTA expectations for relative effectiveness and, where relevant, economic evaluation.

A multilayered framework of intellectual property rights and regulatory protections exists across the EU to support the investment required for pharmaceutical research and development.

The Simultaneous National Scientific Advice (SNSA) pilot project is an initiative by the European Union (EU) Innovation Network aimed at enhancing the efficiency and consistency of scientific advice for pharmaceutical development. It enables developers to obtain coordinated national scientific advice from multiple National Competent Authorities (NCAs) concurrently, streamlining the advisory process and fostering alignment among regulatory bodies.

The European Union is currently refining its pharmaceutical legislation, with proposals from the European Commission now in advanced stages of debate between the European Parliament and the Council. As of October 2025, the core requirements have not been finalised and remain under trilogue negotiation.

National Competent Authorities (NCAs) in the European Union (EU) work closely with the European Medicines Agency (EMA) to regulate the development, authorisation, and post-marketing surveillance of medicinal products. Their shared objective is to maintain high standards of quality, safety, and efficacy. This cooperation underpins the EU’s legal framework for medicines and applies across the product lifecycle, from initial development through to monitoring of products already on the market.