Advanced therapeutics

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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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.

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