7th July 2025 Update

Advertising

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) has published its May 2025 decisions following investigations into complaints about advertising for licensed medicines. See here for further information on the decisions.

Artificial Intelligence (AI)

EU

• The European Parliament Committee has published recommendations and a draft Directive on AI and algorithmic management in the workplace. See recommendations to the Commission here

Global

• Six leading international organisations representing patients, healthcare professionals and the pharmaceutical industry have adopted a new ethical principle on the responsible use of health data and technology, including the use of artificial intelligence in healthcare. See IFPMA press release for further information and consensus framework here

UK

• The United Kingdom has become the first country in the world to join a new global network of health regulators focused on the safe, effective use of artificial intelligence (AI) in healthcare. See MHRA press release for further information.

• The MHRA has now opened phase 2 of the AI Airlock, the regulatory sandbox for AI as a medical device and sent out a call for applications. See MHRA press release here . For further information on eligibility and how to apply, see here. For background information on the AI Airlock, including new guidance on the AI Airlock background, see here

Clinical Trials

EU

• The European Medicines Agency (EMA) has opened a consultation on ICH E20 guideline on adaptive design for clinical trials step 2b. The consultation is open until 30 November 2025. For further information on the consultation see here

UK

• The MHRA has published new guidance to support sponsors after the implementation of the new Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 which come into force on 28 April 2026. The guidance is available on a central hub – see here and includes guidance on i) Clinical trials for medicines: apply for approval in the UK ; ii) clinical trials for medicines: expert advice; iii) clinical trials for medicines: labelling ; iv) clinical trials for medicines: notifiable trials ; v) clinical trials for medicines: modifying a clinical trial approval ; vi) clinical trials for medicines: ending a clinical trial ; vii) clinical trials regulations: transitional arrangements; viii) clinical trials for medicines: collection, verification and reporting of safety events; ix) clinical trials: non-investigational medicinal products

Data Privacy

EU

• The Council of the European Union and the European Parliament have announced an agreement on the law regarding cross-border GDPR enforcement. The final text is still to be published but see Council’s announcement and parliament’s announcement for further information.

• The European Commission has officially extended the UK adequacy decision to December 2025. See here for further information.

UK

• The Data (Use and Access) Bill has now received Royal Assent when the Bill becomes an Act of Parliament (The Data (Use and Access) Act 2025). See here for further information and the Act

• The Information Commissioner’s Office (ICO) has published guidance on the Data (Use and Access) Act 2025. See here for the guidance and further information. See also Department for Science, Innovation and Technology published guidance on the new Act here

• The ICO has launched a consultation to update guidance on international data transfers and UK GDPR. The consultation is open until 7th August 2025. See here for further information including how to respond to the consultation.

Intellectual Property

UK

• The Intellectual Property Office (IPO) has published new guidance for trade mark applicants following the Supreme Court judgement in SkyKick v Sky. The guidance clarifies what is expected when filing specifications, and outlines changes to examination practices. The changes take effect immediately. See here for further information.

Market Access

EU

• The European Commission is hosting an international conference on 2 July 2025 entitled “EU health technology assessment: Advent of a new era of collaboration”. See here for further information.

Medical Devices

EU

• The European Commission has announced new rules for the simplification of instructions for the use of medical devices in electronic format. See European Commission announcement for further information.

• The EU Directorate – General for Health and Food Safety has published an FAQ on the interplay between The Medical Devices Regulation and In-vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act. See here for further information.

• The EU Directorate – General for Health and Food Safety has published a question and answers document regarding performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746. See here for further information.

• The EU Directorate – General for Health and Food Safety has published an updated guidance on the qualification and classification of software which sets out the criteria for the qualification of software falling within the Medical Devices Regulations. See here for updated guidance.

• The EU Directorate – General for Health and Food Safety has published a guidance on the safe making available of medical device software apps on online platforms. See here for the guidance.

UK

• The new Post-Market Surveillance regulations have come into force requiring medical device manufacturers to proactively monitor the safety and performance of their products once on the market. See MHRA press release for further information. Further information on the Post-Market Surveillance requirements is available here and here

Policy, Strategy and Trade

UK

• The MHRA has published its final business plan for 2023-2026, reaffirming its commitment to keeping patients safe and enabling access to high quality and effective medical products through innovation across the UK. See MHRA press release for further information.

• The Association of the British Pharmaceutical Industry (ABPI) has published its response to the UK government’s new Industrial Strategy. See ABPI press release for further information.

Regulatory

EU

• The European Commission has launched the COMBINE Project 1 pilot to explore the coordinated assessment of combined study applications across the clinical trial and medical device regulatory frameworks. The aim is to streamline the authorisation process and reduce the administrative burden for sponsors. See here and here for further information.

• The EMA has published its Human Medicines Highlights for June 2025 with information on new medicines approvals and new medicines recommended for approval. See here for further information.

• The EMA has published a consultation on ICH M4Q – guideline on the Common Technical Document for the registration of pharmaceuticals for human use – Quality – step 2b. The consultation is open until 24 October 2025. See here for further information.

For further information on these developments and how it could affect business, please contact us, we are always happy to provide our insights.

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