Pharmaceutical regulation

The life sciences sector encompasses companies in the fields of pharmaceuticals, biotechnology and medical technology that focus on the research, development and commercialisation of a wide range of products that have a medical application. Such products include pharmaceuticals (ie everything from over-the-counter painkillers to advanced therapies for treating diseases such as cancer or HIV), medical devices (eg plasters, syringes, heart stents, pacemakers, etc) and diagnostics. This subtopic provides an overview of pharmaceutical regulation in the EU.

In the EU, a large amount of the regulation originates from directives or regulations and is supplemented by guidance issued by the European Commission and by the European Medicines Agency (EMA), the decentralised agency of the EU responsible for the scientific evaluation, supervision and safety monitoring of medicines.

Regulation of medicinal products

Article 1(2) of Directive 2001/83/EC, the Pharmaceutical Code defines a medicinal product as a substance that is either:

•
presented as preventing or treating disease, or
•
used to correct or modify a physiological function by pharmacological, immunological or metabolic action, or to make a medical diagnosis

Practice Note: Introduction to the regulation of medicinal products—EU provides an

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

TAKE A FREE TRIAL

Latest EU Law News

EFPIA leads healthcare associations in challenging ECHA's PFAS restriction assessment approach

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and eight other healthcare associations have raised concerns that the European Chemicals Agency (ECHA) will not conduct individual sector assessments for medicines as part of its proposed universal restriction on PFAS chemicals. While the healthcare sector remains within the restriction's scope, ECHA indicated that 'other medical applications' covering medicinal products and manufacturing will not be individually assessed during preparation of final opinions by the Risk Assessment Committee and Socio-Economic Analysis Committee. The associations argue this approach prevents the European Commission from understanding public and animal health impacts and urge ECHA to ensure dedicated assessment of the healthcare sector within the PFAS restriction process.

European Commission adopts delegated regulation on EMIR active account requirements

The European Commission has adopted a delegated regulation supplementing article Article 7a of the European Market Infrastructure Regulation (Regulation (EU) No 648/2012) (EMIR) (as introduced by Regulation (EU 2024/2987) (EMIR 3)) containing regulatory technical standards (RTS) for active account requirements. The delegated regulation implements EMIR 3 provisions intended to reduce financial stability risks from EU exposure to third-country central counterparties by requiring certain counterparties to maintain operational active accounts at EU CCPs. The rules establish operational conditions including IT connectivity and stress testing requirements, representativeness obligations for euro and Polish zloty interest rate derivatives, and six-monthly reporting requirements to competent authorities.

Commission publishes updated clinical trials guidance package

The European Commission's Directorate-General for Health and Food Safety has published a comprehensive package of updated clinical trials guidance documents, all endorsed by the Clinical Trials Coordination and Advisory Group (CTAG) on 15 October 2025. The package includes new recommendations on criteria for selecting a reporting Member State under Article 85(2)(c) of the Clinical Trials Regulation, establishing a workshare criterion when proposed reporting Member States decline the role, which occurs in approximately 30% of applications. The Commission has updated its recommendation paper on decentralised elements in clinical trials (Version 02), superseding the December 2022 version, with revised national provision overviews and guidance on informed consent, investigational medicinal product delivery, and remote monitoring. A new recommendation paper addresses frequent issues identified during Part I and Part II assessments, based on feedback from national competent authorities and ethics committees, covering investigational medicinal product dossiers, protocols, and safety reporting. The package also includes revised guidance on auxiliary medicinal products, effective 1 December 2025 for new applications, featuring an updated classification system distinguishing between authorised, modified authorised, and unauthorised auxiliary medicinal products with corresponding application and safety reporting requirements.

Commission opens consultation on draft EU design IP procedures regulation

The European Commission has published a draft delegated regulation establishing rules for EU design-related intellectual property procedures managed by the European Union Intellectual Property Office. The regulation supplements Regulation (EC) No 6/2002 and replaces the existing Commission Implementing Regulation (EC) No 2245/2002, as required by Regulation 2024/2822 to align Regulation (EC) No 6/2002 with Articles 290 and 291 of the Treaty on the Functioning of the EU. The Commission plans to adopt the regulation in the first quarter of 2026. The consultation period runs from 29 October 2025 to 26 November 2025.