This week's edition of Life Sciences weekly highlights includes news that UK has laid its first major piece of medical device legislation down to reform post-market surveillance requirements with the draft statutory instrument Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, meanwhile MedTech Europe has written an open letter to the European Commissioner demanding urgent reforms of the EU medical devices regulations and responded to the EU Parliament’s joint motion for a resolution to urgently revise the medical device regulations. Also included, is news that the UK government has responded to the proposals to amend the statutory scheme to control the cost of branded health service medicines, the UK introduced global-first draft legislation for the regulation of innovative products manufactured at the point where a patient receives care, the European Commission Implementing Regulation (EU) 2024/2699 of 18 October 2024 to help implement the HTA Regulation has been published in the Official Journal of the EU and will enter into force on 10 November 2024, and the UK ACMD has responded with support for increasing the THC content of hemp products to 0.3% and reducing licensing fees, among other news.

This week's edition of Life Sciences weekly highlights includes news that the Court of Justice of the European Union has handed down two judgments clarifying the application of Regulation (EC) 1924/2006 to food supplement advertising and health claims. Further developments include, a joint call for evidence by the MHRA and the Regulatory Innovation Office (RIO) on the use of AI in medicines development and safety, alongside the launch of a £20 million funding programme to establish new Centres of Excellence for Regulatory Science and Innovation (CERSIs) and the MHRA has updated its Good Clinical Practice inspection guidance with enhanced requirements relating to electronic health records and computerised systems used in clinical trials. Also featured is a guideline by the EMA on required studies to test for drug interactions with other drugs or food in the gastrointestinal tract is open for consultation and confirmation that the ICO will transition to the Information Commission on 30 September 2026 while continuing to operate under the ICO name.

This week's edition of Life Sciences weekly highlights includes analysis by Freshfields Bruckhaus Deringer of the UK government’s response to the findings of the Whitehead Review into equity in medical devices and a Law360 analysis of a group claim filing in the UK against Grindr, a dating app, for mishandling users’ sensitive personal data (eg HIV status). Also included, is news that the European Parliament approved the European Health Data Space agreement to improve access to health data electronically, the EMA published recommendations to facilitate the availability and supply of critical human medicines, the European pharmaceutical industry issued a statement on the proposed AI regulation in relation to a medicinal product’s lifecycle, and news that the Advertising Standards Authority (ASA) identified through its AI tool an offending ad by an unlicensed product that made medicinal or medical claims about the treatment of menopause symptoms and it ruled that a TV ad misleadingly implied that Flarin was better for treating joint pain than other ibuprofen products, among other news.

This week's edition of Life Sciences weekly highlights includes news analysis of the Prescription Medicines Code of Practice Authority (PMCPA) consultation to update the 2021 ABPI Code and the PMCPA Constitution and Procedure by Jayne Packham Consultancy and news of the Commission’s proposal to amend the MDR and IVDR regarding transitional arrangements for certain high-risk IVDs, a gradual roll-out of EUDAMED and information obligation in case of interruption of supply. Also included is news that the EMA has launched a new submission management system, IRIS, that will exclusively impact centrally authorised products (CAPs) and the Commission has launched the 2024 small and medium-sized enterprises (SME) Fund to provide SMEs with financial support to protect their IP rights.

This week's edition of Life Sciences weekly highlights includes Law360 discussion of the Unified Patent Court ruling that Amgen’s patent covering Repatha, a cholesterol drug, was not valid in the EU and News Analysis by Covington & Burling LLP about the European Commission’s publication of the NIS 2 draft Implementing Regulation in June that regulates the security of digital network and information systems such as critical healthcare systems and devices. Also included, is news that the Re-elected European Commission President, Ursula von der Leyen, proposed two legislative priorities, a European Biotech Act in 2025 and a Critical Medicines Act, as part of the Commission’s five-year plan, the Court of Justice held that the Commission did not give the public sufficiently wide access to the purchase agreements for coronavirus (COVID-19) vaccines, the EU pharmaceutical industry have released a detailed position paper on the European Health Data Space (EHDS), MedTech Europe has urged the Commission urgently to further amend the medical devices regulations which it feels have proven not fit for purpose as it stands, meanwhile, Q&A guidance was released on the most recent legislative amendments to the medical devices regulations, a PRO-MaP initiative launched to enhance the methodological reporting and transparency in scientific publications and the FDA will establish a Rare Disease Innovation Hub dedicated to significant unmet needs, among other news.

This week's edition of Life Sciences weekly highlights is a relatively light news cycle that includes an analysis of the Tobacco and Vapes Act 2026 and its implications for retailers, manufacturers, distributors and enforcement authorities, including new offences, reasonable steps defences and compliance obligations. Also included is news that the European Commission has published a revised version of Annex 19 of the EU Guidelines for Good Manufacturing Practice (GMP), introducing updated requirements for reference and retention samples for parallel imported, distributed and traded medicinal products, as well as news that the European Parliament has adopted a resolution calling for the temporary suspension of the Extended Producer Responsibility (EPR) provisions under the revised Urban Wastewater Treatment Directive (UWWTD) and requested a new impact assessment of their impact on the pharmaceutical and cosmetics sectors. Further developments includes the European Commission publishing implementing decisions and revised MDCG guidance on harmonising labelling requirements for medical devices and in vitro diagnostic medical devices, with a transition period for manufacturers to implement the updated standard, among other stories.

This week's edition of Life Sciences weekly highlights includes analyses by Freshfields LLP on the UK Law Commission’s project to review the current UK product liability regime and AstraZeneca lost an argument that it should not have to pay £1.3m of legal costs for a series of interim injunctions. Also included, is news that the European Commission has published new Variations Guidelines to support the implementation of the new Regulation (EC) No 1234/2008 as amended (the Variations Regulation) that came into force in January 2025, Medicines for Europe published an open letter criticising the Council for attempts to dilute the Critical Medicines Act and calling for key reforms, the EMA updated pharmacovigilance requirements and ended the EudraVigilance pilot phase, the European Commission together with the HMA and EMA have jointly announced two new 5–year targets for clinical trials, MHRA launched a pilot scheme for Route B substantial modifications to clinical trials, the Association of British HealthTech Industries published an industry report that calls for the urgent need to better prioritise and fund in vitro diagnostics, and the Patient Safety Commissioner published an Impact Paper reviewing the first three years of the PSC; among other stories.

This week's edition of Life Sciences weekly highlights includes a Law 360 analysis on the Court of Appeal dismissing Salts Healthcare Ltd’s renewed attempts to find Pelican Healthcare Ltd liable for infringing one of its patents over an ostomy bag and an analysis by Hepworth Browne of the UK Supreme Court’s ruling in Emotional Perception AI Ltd v Comptroller-General of Patents, in which the court reshaped the foundations of UK patent law by reorientating the assessment of exclusions to patentability. Also included, is news that the Court of Appeal dismissed the appeals in a biotechnology patent dispute regarding the production of microbial oil for nutritional products, the EU General Court issued orders in challenges concerning the revised Urban Wastewater Treatment Directive (UWWTD) on the grounds of admissibility, not addressing the substantive question of the legality of the Extended Producer Responsibility (EPR) scheme, the MHRA and NICE have jointly published guidance on the Integrated Scientific Advice service, EFPIA published a report assessing the economic and societal contribution of industry-sponsored clinical trials in Europe as well as a comparative analysis of biopharmaceutical strategies across ten countries, and news that the UK Research and Innovation announced its first AI strategy, the Department for Science, Innovation and Technology (DSIT) announced £150m for three UK Research and Innovation programmes, as well as MHRA updates reporting a rise in clinical investigations, the launch of a fee waiver pilot for small firms, a statement on the paused PATHWAYS clinical trial, and enforcement action involving the seizure of unlicensed weight loss medicines, among other stories.

This week's edition of Life Sciences weekly highlights includes news that the Artificial Intelligence Board and MDCG published a joint guidance clarifying the interaction between the Medical Devices Regulations and the EU AI Act, MDCG further issued a comprehensive guidance document, addressing performance studies of in vitro diagnostics medical devices, and further endorsed an important revision of the existing guidance for the classification of medical device software under the Medical Devices Regulations, the MHRA announced its position as the first country to join the HealthAI Global Regulatory Network, a new international platform for healthcare AI regulation, further announced the opening of applications for the second round of its AI Airlock regulatory sandbox programme and published its final MHRA Business Plan for the 2025–2026 period. Also included, is news that Medicines for Europe presented five trade policy recommendations to the European Commission, ICH published draft guideline on adaptive design in clinical trials, the EMA published a revised version of its Anti-Fraud Strategy 2021 and the life sciences industry commented on the UK's Modern Industrial Strategy 2025, among other stories.

This week's edition of Life Sciences weekly highlights includes a key Patents Court decision in Laboratorios Leon Farma SA v Comptroller-General of Patents clarifying the application of the SPC Regulation in relation to prior marketing authorisations, as well as an important Tribunal decision addressing the disclosure of clinical trial-related information under data protection law. Further news included is that the MHRA and NICE announced an aligned joint pathway for licensing and value assessment decisions to expedite new medicine authorisations alongside the launch of a new Integrated Scientific Advice service to align evidence requirements for both, the DHSC outlined NHS structural reform including the elimination of NHS England to create integrated health organisations and the EMA has introduced new tools under its priority medicines (PRIME) scheme to support the development of medicines for unmet medical needs. Additional developments include that the ICH has published an updated quality risk management guidance briefing pack, an ABPI report proposes how NHS data can be used to improve recruitment in clinical trials and recent ASA rulings sanctioned several social media advertisements for food supplements that implied those supplements could prevent, treat or cure symptoms of the menopause, among other stories.

This week's edition of Life Sciences weekly highlights includes news that the ABPI and the Prescription Medicines Code of Practice Authority (PMCPA) published the 2024 ABPI Code of Practice which will come into effect on 1 October 2024 replacing the 2021 Code which govern the advertising of prescription-only medicines and interactions between the pharmaceutical industry and the healthcare sector. Also included is news that the MHRA opened applications for AI developers to join its AI Airlock regulatory sandbox for medical devices, a blog by the Chief Executive of the HRA discusses the role of AI in clinical research including its use in its regulatory process, a NICE review concluded that the new severity modifier introduced in 2022 to enhance the evaluation of medicines for severe diseases is functioning as intended, the European Commission released evaluations of the Innovative Medicines Initiative 2 (IMI2) programme and the Innovative Health Initiative (IHI) confirming their added value to enhancing health research, and news that the Advertising Standards Authority (ASA) decided that Shop TJC’s teleshopping ad made misleading medical claims about a blue and red light therapy electric toothbrush and Huel and The Skinny Food Co breached the CAP Code for making nutrition health claims and general health claims in their ads, among other news.

This week's edition of Life Sciences weekly highlights includes analysis of the criteria for classifying an AI model with ‘systemic risk’ under the EU AI act. Also included, is news that the European Commission opened a feedback period on a draft implementing regulation on electronic instructions for use for certain medical devices, the MHRA published the first part of the government response to the consultation on assimilated EU law for medical devices and updated its guidance for manufacturers and wholesalers following the Windsor Framework agreement, as well as news that the Commission opened two consultations on evaluation of the Cosmetic Products Regulation and of plant variety rights legislation, the HRA implemented guidance updates to reflect the National Institute for Health and Care Research's (NIHR) transition from the Clinical Research Network (CRN), and the EMA released three-year work plans for its Oncology Working Party and Infectious Diseases Working Party, among other stories.