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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.
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.
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.
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.
What is the difference between an appeal and a review?What is an appeal?An appeal in insolvency proceedings is no different to an appeal in normal litigation. An appeal will be allowed only if the appeal court is satisfied that the decision of the lower court was 'wrong' or 'unjust because of a
Strike out—making an application to strike out a statement of caseA strike out order can be made either following an application by the parties or on the court's own initiative. This Practice Note deals with the scenario of the order being made following a party's application.Making an application
Contributory negligence in personal injury claimsContributory negligence is a partial defence which can lead to a discount in damages.Other defences may also be relevant. See Practice Notes: Did the claimant consent to the risk of injury? and Was the claimant involved in an illegal activity?If a
Template for regulatory references given by SMCR firms and disclosure requirements[Insert addressee details]Dear [insert name][It is our understanding that [insert name of prospective employee] [was an employee of yours between the dates of [insert dates as appropriate] OR is a current employee of
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