Coronavirus (COVID-19)

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This subtopic brings together news and other resources regarding the implications of the coronavirus (COVID-19) pandemic for the UK and European life sciences industry.

Regulatory implications for the UK and European life sciences industry

Coronavirus (COVID-19) presents an unprecedented challenge to the global life sciences industry. The UK and EU regulators have provided guidance in response to the crisis, as well as to support research and development (R&D) designed to contain the impact of the pandemic.

For a discussion of the key regulatory implications

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Latest Life Sciences News

MHRA launches consultation to evaluate the Medicines and Medical Devices Act 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation seeking stakeholder feedback on the operation and impact of medicines and medical devices legislation. The review, mandated under Part 6, Regulation 48 of the Medicines and Medical Devices Act 2021, examines four key regulations: the Human Medicines Regulations 2012, Medical Devices Regulations 2002, Medicines for Human Use (Clinical Trials) Regulations 2004, and Medicines and Medical Devices (Fees) Regulations. The consultation, running until 19 September 2025, aims to assess whether the legislation effectively protects public health without imposing unnecessary regulatory burdens. Findings will inform a report to be published by the Secretary of State for Health and Social Care.

European Parliament publishes study on AI and civil liability

The European Parliament’s Policy Department for Justice, Civil Liberties and Institutional Affairs has published a study examining the EU’s regulatory approach to civil liability for artificial intelligence (AI) systems. The study, commissioned at the request of the Committee on Legal Affairs, recommends implementing a strict liability regime for high-risk AI systems. It advocates for a single responsible operator model to prevent regulatory fragmentation across EU Member States and emphasises the importance of legal certainty, efficiency and harmonisation in the regulatory framework.

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.

EFRAG launches portal analysing 1st ESRS sustainability statements

The European Financial Reporting Advisory Group (EFRAG) has launched its 'EFRAG 2025 State of Play' portal, providing analysis of the first 656 European Sustainability Reporting Standards (ESRS) statements issued under the Corporate Sustainability Reporting Directive (CSRD). The portal includes a statistics dashboard and report repository showing only 10% of companies identified all ESRS standards as material, while 55% disclosed climate transition plans. The analysis will inform EFRAG's work on ESRS simplification following the European Commission's March 2025 mandate.

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