20th April 2026 Update

Advertising

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) has published March decisions made by it following investigations into complaints about advertising for licensed medicines. See here for further information.

Artificial Intelligence (AI)

EU

• The European Parliament has adopted its position on the Digital omnibus AI regulation proposal. Negotiations with the Council on the final form of the law will now begin. See here for further information.

UK

• The MHRA has published the latest edition in its blog series, looking how emerging technologies, like AI are transforming healthcare. See MHRA blog here.

Animal Testing

EU

• The European Medicines Agency (EMA) has issued a draft qualification opinion for a new methodology in preclinical research, which reduces the number of animals used in medicines development. The draft qualification opinion is open for consultation until 12 May 2026. See here for further information including how to contribute to the consultation.

UK

• The MHRA has issued guidance on its approach to assessment of applications for medicines that use alternative methods to replace animals in science. The approach supports the government’s long-term strategy to reduce use of animals in drug development. See press release and guidance for further information.

Clinical Trials

UK

• The MHRA has published guidance on compliance with ICH E6 good clinical practice (GCP) in the United Kingdom, which provides information on how GCP principles are implemented and enforced in UK clinical trial legislation. See here for further information.
• The MHRA has published guidance on quality and risk proportionality in UK clinical trials. See here for further information.
• The Health Research Authority (HRA) has published a blog article on the new obligations under the Clinical Trial Regulations relating to research transparency. The article also covers transitional arrangements. The new Clinical Trial Regulations come into force in the UK on 28 April 2026. See blog article for further information.
• The HRA has launched a new modification tool to help sponsors and researchers prepare for the new Clinical Trials Regulations. See here for further information.
• The MHRA Clinical Trials Regulations webinar recordings with information about plans for implementing the new Clinical Trials Regulations have been published to view. See here for further information.

Data Privacy

EU

• The European Data Protection Board (EDPB) has published a one-stop shop case digest on the legal basis of ‘legitimate interest’. See here for further information.
• The EDPB has published a report summarising a stakeholder event held in December 2025 regarding anonymisation and pseudonymisation. The report outlines the complexities of anonymisation and pseudonymisation and captures stakeholder insights on the subject. See here for further information.

UK

• The Information Commissioner’s Office (ICO) has published a report on automated decisions in the recruitment process, setting out the ICO expectations and guidance. See here for further information.
• The ICO has updated its guidance on compatibility and reuse of personal information. See here for further information.
• The ICO has updated its guidance on recognised legitimate interest. See here for further information.

Environmental

UK

• The MHRA has published guidance on environmental risk assessments for medicinal products in the UK. See here for further information.

Intellectual Property

UK

• The Intellectual Property Office (IPO) has launched its new digital patent service to apply for, manage or renew UK patents. See here for further information. The IPO has also issued statutory guidance for the use of the One IPO digital services and provided guidance on the One IPO digital transformation programme.
• The IPO has published a set of fact sheets to assist organisations on preparing UK patent applications and file abroad. See here for further information.
• The IPO has published guidance on applying for a patent, search and examination and adding inventors. See here for further information.
• The Manual of Patent Practice has been updated, including the section on supplementary protection certificates for medicinal products. See here for guidance and information on recent updates and here for information on the recently updated section on supplementary protection certificates.

Manufacturing

EU

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published an article in response to the European Chemicals Agency Risk Assessment Committee and the Socio-Economic Analysis Committee draft Opinion regarding the proposed restriction on PFAS (synthetic ‘forever chemicals’), arguing that the proposed restriction on PFAS does not take into account medicines or their manufacturing processes. The opinion is currently open to consultation until 25 May 2026. See here for EFPIA article and here for information on the consultation and how to respond.

Market Access

UK

• National Institute for Health and Care Excellence (NICE) and the MHRA have launched a new aligned pathway to help bring NICE’s decision-making process forward to run alongside the MHRA’s. The aligned pathway launched on 1 April 2026. See NICE blog and updated MHRA guidance for further information.
• Changes to NICE’s cost-effectiveness thresholds have now taken effect. See here for further information.

Medical Devices

UK

• The MHRA has expanded the AI Airlock programme, the regulatory sandbox for artificial intelligence as a medical device, with additional funding of £1.2 million over the next three years. See here for further information.
• The UK MHRA and US Food and Drug Administration (FDA) are strengthening cooperation on medical device regulation to support faster access to innovative technologies for patients in both countries. See here for further information.
• The Department of Health and Social Care (DHSC) has published an explanatory memorandum setting out the government’s summary of a proposal for a regulation on simplifying and reducing the burden of rules on medical devices and in vitro diagnostic devices. See here for further information.
• The MHRA has published a series of guidance on clinical investigations for medical devices including medical devices that need a clinical investigation, clinical investigations: statistical considerations, clinical investigations: investigators’ responsibilities, clinical investigations: biological safety assessments, clinical investigations for electrically powered devices, approving clinical investigations, clinical investigations: compiling a submission, clinical investigations in Great Britain, and clinical investigations in Northern Ireland

Medicines Shortages

UK

• The Association of the British Pharmaceutical Industry (ABPI) has published a blog article on medicines shortages setting out the issue and how it is working to avoid medicines shortages. See here for further information.
• The DHSC has published guidance on medicine supply management, providing information on the systems and processes the DHSC and NHS use for responding to medicines shortages. See here for further information.

Policy, Strategy and Trade

EU

• EFPIA has issued a statement on the conclusions of the EU-India Free Trade Agreement negotiations, recognising that the agreement presents opportunities, but that meaningful further engagement is necessary on areas such as the protection of regulatory data. See here for further information.

UK

• The government and the UK life sciences industry have launched a joint taskforce to drive innovation in the UK’s commercial environment for medicines. See here for further information.
• The UK and US have agreed the full text of the landmark arrangement on pharmaceutical trade and pricing. See here for further information. See also full details of the agreed arrangement

Rare Diseases

UK

• The ABPI has published a report on the economic value of improving treatment for rare diseases. See ABPI press release for more information, including link to the report.

Regulatory

EU

• The EMA has published its Human Medicines Highlights for April, including new medicines recommended for approval and new information on approved medicines. See here for further information.

UK

• The DHSC has opened a call for evidence on the UK’s legislative framework for substances of human origin. See DHSC press release for more information, including the call for evidence document and how to respond. The call for evidence is open until 17 June 2026.

Safety

UK

• The MHRA has published its safety round-up for March 2026. See here for further information.