REGULATORY UPDATE / MONTHLY

October 2026

DEVELOPMENTS

TOPICS

OPEN DEADLINES

Every LS Law Monthly Regulatory Update is researched, curated and written by our legal experts. Drawing on hands-on, in-house experience across the life sciences sector, they look beyond what has changed to consider what matters, why it matters and what it could mean in practice.

AUTHOR’S NOTE

Welcome to our LS Law Regulatory Update, covering all the key developments over the past month. Although it has still felt like Summer at times during September, Autumn is definitely upon us and it has been back to business as usual during September, with several announcements catching our eye over the last few weeks.

Firstly, the National Commission into the Regulation of AI in Healthcare has just published a landmark set of recommendations to reform the regulation of software and AI-enabled medical devices. We have also seen the announcement of a call for evidence on the use of AI in medicines development. This is an important initiative and aims to develop a blueprint for regulation, tackling issues of accountability, algorithm bias and data sharing head on.

In recent weeks the European Commission has also announced two new legislative proposals, Firstly, a new Public Procurement Act to replace three 2014 directives with a single, directly applicable EU regulation. Whilst this reduces national fragmentation of course, the downside is that transitioning e-procurement architectures will impose considerable short-term administrative challenges. The European Commission has also announced a proposed European Innovation Act, aimed at ensuring that Europe's most innovative ideas can be developed and financed in Europe. Although the proposal would unlock an estimated €10.2B billion a year in extra financing and fast-tracks R&D procurement cycles to two months, the framework is overly narrow in scope and largely overlooks the foundational role of universities and academic researcher mobility.

Finally, another interesting ruling from the PMCPA on press releases, which provides a useful reminder of what is truly factual information about a medicine (and can be made available to the general public) as opposed to promotional content (which cannot).

We hope you enjoy this latest update.

Rebecca

9 October 2026

Advertising

3 ITEMS

The Prescription Medicines Code of Practice Authority (PMCPA) has ruled that GSK has breached clauses 2 and 5.1 of the Code of Practice for the Pharmaceutical Industry (Code) for failing to provide full and frank disclosure of all relevant information in its submission and communications for Case/0269/08/24.

See GSK – Case/0874/02/26 for further information.

The PMCPA has ruled that Eli Lilly has breached the Code (clauses 2, 3.1 and 5.1) for provision of a press release to the BBC which promoted a prescription only medicine prior to the grant of its marketing authorisation.

See Eli Lilly – Case/0685/08/25 for further information.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published August decisions made by it on advertisements alleged to have breached legislation on advertising medicines.

See here for further information.

Animal Testing

1 ITEM

The European Medicines Agency (EMA) has launched a new voluntary data submission pilot to facilitate the sharing of data generated using new approach methodologies.

See here for further information.

Artificial Intelligence (AI)

5 ITEMS

The Atlantic Council has published a report on accelerating and securing the AI data supply chain for the health and biopharmaceutical sectors.

The report looks at specific challenges facing the industry including regulatory challenges and proposals for policymaking. See here for further information.

The MHRA has published the recommendations from the National Commission into the Regulation of AI in Healthcare, which was established to advise on a future regulatory framework for AI in healthcare.

A government response will follow, setting out how government will take forward the recommendations. See press release and here for further information, including the detailed recommendations. The Health Research Authority (HRA) has welcomed the recommendations. See HRA press release for further information.

The MHRA and the Regulatory Innovation Office have opened a call for evidence on the use of AI in medicines development and safety.

The consultation is open until 22 December 2026. See here for further information including how to respond to the call for evidence.

RESPOND BY 22 DEC 2026

The Department for Science, Innovation and Technology (DSIT) has published an AI Risk Management Toolkit providing guidance to assess and manage risks when designing, procuring and delivering AI products.

See here for further information.

The National Cyber Security Centre (NCSC) has published a blog article on the hidden risk of shadow AI (unapproved AI tools used by staff).

See here for further information.

Clinical Trials

1 ITEM

The MHRA has updated its Guidance on good clinical practice inspections by introducing a new dossier requirement for computerised systems and enhanced electronic health record audit trail standards.

See here for further information.

Competition Law

2 ITEMS

The European Commission has adopted its Guidelines on the application of Article 102 TFEU to abusive exclusionary conduct by dominant companies.

See here for further information.

The Polish Office of Competition and Consumer Protection (UOKiK) has fined four pharmaceutical wholesalers a total of over PLN 900 million (approximately EUR 200 million) for illegally exchanging confidential information over a 10-year period.

See here for further information.

Data Protection

3 ITEMS

The European Data Protection Board (EDPB) has finalised guidelines on the application of the power to impose administrative fines, a major step in further aligning how data protection authorities decide whether an administrative fine should be imposed.

See here for further information.

The government has confirmed that the Information Commissioner’s Office (ICO) will transition to the Information Commission on 30 September 2026.

See ICO press release for further information.

A new UK GDPR Code of Conduct has been published by the Wales Accord on the Sharing of Personal Information (WASPI).

See here for further information.

Freedom of Information

1 ITEM

The ICO has published guidance on the public interest test following the Supreme Court ruling in DBT v ICO [2025] UKSC 27.

See ICO press release for further information including the guidance.

Health Bill

1 ITEM

Five new impact assessments have been published on the Health Bill as well as one fact sheet, these include proposed Health Bill measures for MHRA reforms

See here for further information.

Health Data

1 ITEM

The European Commission opened a public consultation on a draft implementing regulation detailing the technical and functional framework for HealthData@EU, the cross-border infrastructure for secondary use of electronic health data under the European Health Data Space.

The consultation closed on 29 September following its launch earlier in September. Official adoption by the Commission is planned for the end of 2026. See here for further information.

Innovation Act

1 ITEM

The European Commission has adopted a legislative proposal for the European Innovation Act to unify the single market for research and technology to help Europe’s most innovative ideas be developed, scaled up and financed in Europe.

See European Commission press release for further information.

Innovative Medicines

1 ITEM

The MHRA has updated its guidance on pre-submission requirements for innovative medicines applications, including notification expectations and the circumstances when the MHRA may require a pre-submission meeting.

See here for further information.

Intellectual Property

1 ITEM

The Court of Justice of the European Union (CJEU) has been asked to provide a preliminary ruling on the scope and interpretation of the Supplementary Protection Certificate (SPC) Manufacturing Waiver. The Danish Maritime and Commercial High Court has referred four questions to the CJEU in a dispute between pharmaceutical companies Janssen Biotech and others v Samsung Bioepis NL BV and AGC Biologics A/S).

See Case C-371/26 for further information and referred questions.

Labelling

1 ITEM

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and The European Association of Hospital Pharmacists (EAHP) has published new guidance on single unit barcoding of medicines.

The guidance supports the application of barcodes to each dose of medication with the purpose of reducing medication errors. See EFPIA press release for further information.