Jurisdiction(s):
United Kingdom

Related legal acts

Key definition

Advanced therapy medicinal product definition

What does Advanced therapy medicinal product mean? In legal and regulatory practice, an advanced therapy medicinal product (ATMP) is a human medicine based on genes, cells or engineered tissues, used to treat, prevent or diagnose disease. The term is defined in EU Regulation (EC) No 1394/2007 (read with Directive 2001/83/EC). In the UK, it forms part of retained EU law under the Human Medicines Regulations 2012 and MHRA guidance; in Ireland, the EU regime and EMA procedures apply. Usage is broadly consistent across England & Wales, Scotland, Northern Ireland and Ireland. There are four categories of ATMP: - gene therapy medicinal products - somatic cell therapy medicinal products - tissue...

Advanced therapy medicinal products: EU and UK regulation, classification, clinical trials, manufacturing and authorisation; pharmacovigilance, traceability, GMOs, hospital exemption, and key reforms including SoHO, HTA and UK point-of-care

Published by a LexisNexis Life Sciences expert

Practice notes

Advances in medicine, biomicrobiology and biotechnology have given rise to a state-of-the-art group of medicinal interventions that deploy gene therapy, somatic cell therapy and engineered tissues to prevent, manage or even cure human disease. The newness, intricacy and variety of these products has required fresh regulatory instruments, both legislative measures and guidance, to strike an appropriate balance between risks and patient benefits. In the EU and the UK, lawmakers classify this group as ‘advanced therapy medicinal products (ATMPs)’ to safeguard the highest standards of public health while recognising their unique challenges, particularly around clinical trials, manufacturing and Pharmacovigilance. Yet oversight of genetically modified organisms (GMOs) used as starting materials for ATMPs remains a national matter and therefore varies from one Member State to the next. These divergences have produced a complicated regulatory environment for ATMPs. Oversight of tissues and cells is likewise presently handled at national level, although such inconsistencies are expected to continue only until 2027, when a revised EU regulation is anticipated to take effect. This Practice Note examines what constitutes an ATMP and how it is regulated, and considers where exceptions apply across clinical trials, manufacturing obligations, pharmacovigilance requirements, and related EU and UK processes today to...

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Alexander Roussanov

Arnold & Porter

Alexander Roussanov, a former senior legal adviser in the Legal Department of the European Medicines Agency (EMA), focuses his practice on a broad range of issues related to the life-cycle of medicinal products and medical devices. His experience includes product classification, authorization and conduct of clinical trials for medicinal products and clinical investigations for medical devices, marketing authorization for medicinal products and CE marking of medical devices, pharmacovigilance and device vigilance, marketing and promotion activities, privacy and data protection counseling, and interactions with health care professionals. He is well-versed in certain EMA-specific regulations, including those surrounding advanced therapy medicinal products, marketing authorization procedures, referral procedures, GxP inspections, the Agency's freedom of information policy and clinical data transparency. In addition, he has represented the EMA in litigation in the Court of Justice of the European Union. He has extensive practical experience counseling...

Heba Jalil

Arnold & Porter

Heba Jalil is an associate in the London Life Sciences practice group. She has acted for pharmaceutical companies in relation to a range of litigation and regulatory matters, including public inquiries regarding medicinal products and product liability litigation before the UK courts.Ms. Jalil assists with commercial transactions involved in the development and commercialisation of medicinal products, with particular experience in drafting and negotiating supply and distribution agreements. ...

Web page updated on 21/05/2026

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