Advanced therapeutics

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Advanced therapy medicinal products

The development of medicine, biomicrobiology and biotechnology has led to the emergence of a category of medicinal product that use gene therapy, somatic cell therapy and engineered tissues for preventing, treating or even curing human diseases. The novelty, complexity and diversity of such products has demanded new regulatory tools to allow an appropriate balancing of the risks and the benefits for the patients. EU and UK legislation regulates this category of products as ‘advanced therapy medicinal products (ATMPs)’ in order to ensure the highest level of protection of public health and to take into account their specific challenges, in particular with regard to clinical trials, manufacturing and pharmacovigilance.

There are three categories of ATMPs that are based on genes, cells (including stem cells), and tissues, respectively. ATMPs are a type of what is known as regenerative medicine (which refers to methods to replace or regenerate human cells, tissues or organs in order to restore or establish normal function and includes cell therapies, tissue engineering, gene therapy and biomedical engineering as well as more traditional treatments

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Latest Life Sciences News

MHRA  launches world-first framework for decentralised manufacture of personalised medicines

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that the application date for groundbreaking new UK legislation has arrived from 23 July 2025. The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, SI 87/2025 will provide the world's first regulatory framework that allows breakthrough personalised medicines such as cancer and immunotherapy (ie CAR-T) treatments to be prepared in small or individual batches. It aims to transform the manufacture of innovative medicines at the point of patient care.

Commission publishes template for public summary of training content for GPAI models

The European Commission has published an Explanatory Notice and Template to guide providers of general-purpose AI (GPAI) models in meeting their obligation under Article 53(1)(d) of the EU AI Act (Regulation (EU) 2024/1689) to publicly disclose a sufficiently detailed summary of the data used to train their models. This requirement applies from 2 August 2025 and aims to promote transparency, support rights enforcement, and balance commercial confidentiality with public interest.

Life Sciences weekly highlights—24 July 2025

This week's edition of Life Sciences weekly highlights includes news that the UK government has published its final response to a consultation on new medical device legislation that would improve routes to market and it released its Life Sciences Sector Plan, outlining significant regulatory changes through 2035. Also included is an analysis by Freshfields LLP that considers the three chapters of the final General-Purpose AI Code of Practice, an MLex analysis of the European Commission’s guidelines on the EU AI Act’s rules for general-purpose AI models and a Law360 story on the Court of Appeal’s refusal to revive AstraZeneca’s patent for its billion-dollar diabetes drug enabling generic competition. Further stories this week include that the EU pharmaceutical industry (EFPIA) expressed concerns and a proposal  in response to the Commission’s release of its Multiannual Financial Framework package for 2028–34 that totalled nearly €2trn, the EFPIA also submitted its General Data Protection Regulation Code of Conduct on Clinical Trials and Pharmacovigilance for final assessment, groundbreaking new UK legislation applies from 23 July 2025 providing the world's first regulatory framework that transforms the decentralised manufacture of innovative medicines at the point of patient care, the Home Office and DHSC published a joint response to a report on barriers to Schedule 1 controlled drugs research, Commission Implementing Regulation (EU) 2025/1467 which establishes the EU SoHO Platform to register and exchange information concerning the donation and supply of substances of human origin (ie blood, tissues and cells) published in the Official Journal,  and the Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 introduces flexibilities concerning how medicines are prepared, assembled, dispensed, sold, and supplied within pharmacy services, among other stories.

High Court discharges super-injunction in Afghan data breach case (MoD v Global Media and Entertainment Ltd)

Public Law analysis: The High Court discharged a super-injunction in the case of Ministry of Defence v Global Media and Entertainment Ltd, marking a significant moment in the intersection of privacy, national security, and open justice. This judgment (the Judgment) rebalances the competing interests of state secrecy and the public’s right to know, with the Judgment emphasising the need for democratic accountability in the handling of sensitive government errors. The Judgment (which was made public together with the earlier judgments in the case) serves as a crucial reminder of the limits of secrecy in the face of evolving evidence and the fundamental importance of freedom of expression. Written by Dan Tench, partner, and Rosie Coles, associate, at CMS.

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