REGULATORY UPDATE / MONTHLY

November 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 November Regulatory Update providing you with the key legal and regulatory updates over the last month.

As usual lots of interesting snippets this month and we begin with the Government response to the National Commission's Recommendations on the Regulation of AI in healthcare. Whilst the Government confirmed it would accept all of the recommendations and the response commits to developing an agile approach to AI device regulation, supporting innovation whilst maintaining patient safety and public trust, we must wait a while for further detail.

The Government has agreed to publish draft guidance in December 2026 followed by an implementation roadmap setting out timelines and responsibilities across all 44 recommendations, which will be published in Spring 2027.

Another consultation outcome was also published this month on indefinite recognition of CE marked medical devices in Great Britain. Perhaps not surprisingly, the government has decided to proceed with legislative changes to indefinitely recognise CE marked medical devices certified under EUMDR and EU IVDR.

We have also seen Italy's Data Protection Authority, Garante, issue a hefty fine against IQVIA Italy for unlawful processing of patient health data. Garante found that the data was not anonymous, as claimed by IQVIA. In the context of recent focus on the area of anonymisation and pseudonymisation, it is perhaps not surprising we are seeing significant fines when controllers get this wrong.

Also, on the subject of data privacy, the Council of Europe agreed its negotiating mandate for the proposed Digital Omnibus regulation, which provoked a critical statement from the privacy organisation NOYB, specifically on the position taken in the mandate that ‘legitimate interests’ can serve as a valid legal basis for processing personal data in the context of developing and operating AI systems and models. It is going to be interesting to see how that one plays out.

Sanofi also avoided a fine for alleged anti-competitive disparagement of a competitor vaccine by offering commitments to the European Commission, which were accepted by the Commission as a satisfactory way of addressing their concerns.

This is an area of increased focus and the decision is well worth a read.

We hope you enjoy our November update.

Rebecca

11 November 2026

Advertising

2 ITEMS

The Prescription Medicines Code of Practice Authority (PMCPA) has ruled that CSL Seqirus has breached the ABPI Code of Practice for the Pharmaceutical Industry, (including Clause 2), for failure to disclose substantial payments to a healthcare organisation over a number of years and for failure to have appropriate documentation for the payments.

See CSL Seqirus - Case/0796/11/25 for further information.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published September 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 endorsed a joint statement from the International Coalition of Medicines Regulatory Authorities calling on medicine developers, manufacturers, regulators and national control laboratories to continue to advance and implement alternative methods or approaches to animal testing.

See EMA press release for further information. The MHRA has also endorsed the joint statement. See also MHRA press release here.

Artificial Intelligence (AI)

6 ITEMS

The European Commission has published an update to the ERA Living Guidelines on the responsible use of Generative AI in research.

See European Commission press release for more information, including updated Guidelines.

The European Commission has published an Implementing Decision on the first harmonized standard under the AI Act for high-risk AI systems.

Under the AI Act, providers who implement the standard EN 18286:2026 receive a legal presumption of conformity with the quality management system requirements under article 17 of the AI Act. See European Commission press release for further information.

The European Commission has opened a public consultation regarding the draft implementing regulation that establishes procedural and enforcement rules under the AI Act.

The consultation is open until 9 November 2026. See here for further information, including how to provide feedback.

RESPOND BY 9 NOV 2026

The EU Joint Research Centre has published data showing AI adoption across EU strategic sectors.

The data shows adoption in the pharmaceutical sector grew from 7% to 23% between 2021 and 2025. See press release for further information.

The Government has published its response to the National Commission’s Recommendations on the Regulation of AI in Healthcare and details how the Government intends to take forward the recommendations made by the National Commission.

See here , Guidance and press release for further information.

Alongside the Government Response to the National Commission’s Recommendations on the Regulation of AI in Healthcare, the MHRA has opened applications for Phase 3 of the AI Airlock, which will focus on post-market surveillance and the safe management of AI-enabled medical devices.

See here for further information.

Clinical Trials

3 ITEMS

The EMA has published a reflection paper on methodological aspects in confirmatory platform trials for consultation.

The consultation is open until 31 January 2026. See here for further information, including how to provide feedback on the consultation.

RESPOND BY 31 JAN 2027

The EMA has confirmed that the Accelerating Clinical Trials in the EU advice pilot, which helps sponsor clinical trial applications, will become a permanent initiative from January 2027.

See here for further information.

According to UK Clinical Research Delivery key performance indicators published to the end of September 2026, the Government hit its target for speeding up clinical trials.

See here for further information. See also Health Research Authority press release.

Competition Law

1 ITEM

Sanofi has avoided a fine as the European Commission has accepted commitments offered by Sanofi to resolve possible anti-competitive disparagement of a competing flu vaccine for vulnerable patients. Sanofi is required to publish corrective statements and has agreed not to use certain promotional materials as part of its commitments.

See European Commission press release for further information.

Data Protection

5 ITEMS

On 21 October the Council of the European Union agreed on its negotiating mandate for the proposed Digital Omnibus regulation, which aims to simplify and streamline the EU’s digital, data protection, privacy and cybersecurity rules.

The mandate controversially retains the recognition that ‘legitimate interests’ can serve as a valid legal basis for processing personal data in the context of developing and operating AI systems and models. See Council of the European Union press release, which includes text of the Council mandate, for further information.

The privacy organisation NOYB has published a critical statement regarding the mandate on the legitimate interest legal basis for AI development.

See NOYB statement for further information.

The Italian Data Protection Authority, Garante has fined IQVIA Italy €7 million for unlawful processing of patients' health data.

See European Data Protection Board (EDPB) press release and Garante press release for further information.

The Information Commissioner’s Office (ICO) has opened a call for evidence to examine the data protection risks and regulatory challenges of agentic AI. The call for evidence is open until 20 November 2026.

See here for further information.

RESPOND BY 20 NOV 2026

The HRA has published its response to the ICO consultation on draft guidance about the use of anonymisation and pseudonymisation for research purposes.

See here for further information, including HRA response.

Enforcement

1 ITEM

The MHRA and Police have seized fake weight loss pens worth £2 million.

See MHRA press release for further information.

Medical Devices

5 ITEMS

The European Commission has selected the first medical devices for joint clinical assessment.

See press release and here for further information.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and other organisations representing healthcare professionals, researchers, innovators and industry across Europe have published a statement calling on the European Parliament and Council to ensure there is a single regulatory pathway for AI-enabled medical technologies.

They have requested the Commission's proposal to move the MDR and IVDR from Section A to Section B of Annex1 of the AI Act be preserved. See EFPIA press release and statement for further information.

The MHRA has published resources to help developers use patient-reported outcomes in digital mental health technologies for evidence generation.

See here for further information.

The MHRA has set out the next phase of MedTech and AI regulation to US industry leaders at AdvaMed 2026.

See MHRA press release for further information.

The MHRA has published the consultation outcome on the indefinite recognition of CE marked medical devices in Great Britain. Having considered the responses to the consultation the Government has decided to proceed with legislative changes to indefinitely recognise CE marked medical devices certified under EUMDR and EU IVDR.

See here for further information.

Pharmacovigilance

1 ITEM

The EMA has opened a public consultation on the Adverse Drug Reaction chapter of the Data Quality Framework.

The consultation is open until 14 December 2026. See here for further information, including how to provide feedback.

RESPOND BY 14 DEC 2026

Real World Data and Evidence

1 ITEM

The MHRA has published supporting guidance, publications, and resources on the use of real-world data and real-world evidence in regulatory decision making for medicines and medical devices in the UK.

See here for further information.

Regulatory

2 ITEMS

The European Commission has recognised Singapore’s regulatory framework for active substances as equivalent to EU standards.

See here for further information.

The EMA has published its Human Medicines Highlights for October 2026 with information on new medicines recommended for approval and new information on approved medicines.

See here for further information.

Safety

2 ITEMS

The MHRA has published its Safety Roundup for October 2026.

See here for further information.

The MHRA is set to introduce new and updated patient information for antidepressant medicines following an extensive review.

See MHRA press release and here for further information. See also Public Assessment Report on the review of antidepressants.

Strategy, Policy, Investment and Trade

3 ITEMS

The European Commission has announced a €65 million funding package under the Horizon Europe work programme to protect and sustain critical scientific data and knowledge infrastructures that support life sciences, medicine development and artificial intelligence in biotechnology.

See here for further information.

The European Commission has launched the RAISE (Resource for AI Science in Europe) initiative to mobilise private-sector and philanthropic support for AI-driven scientific research.

See here for further information.

The MHRA has published its strategy to 2030.

See press release and Guidance for further information. See also ABPI response and HRA response.

Urban Wastewater Treatment Directive

1 ITEM

EFPIA has called for a pause in the implementation of the Urban Wastewater Treatment Directive amid growing concerns about the scientific and legal evidence used in the Extended Producer Responsibility Scheme.

See EFPIA press release for further information.

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THE LS LAWCAST

The Regulatory Question Bomb Ep 1 - Weight Loss Jabs, Indirect Promotion and AI Governance

Listen to this episode

Our new monthly lawcast series, The Regulatory Question Bomb, looks in more depth at the key developments from our regulatory updates and provides practical opinion and commentary from our most experienced industry lawyers.

In this first episode, Wendy is joined by Rebecca, who researches and writes our monthly regulatory update. They discuss two stories from last month’s edition: the MHRA’s summer rulings on online pharmacies promoting weight loss injections to the public, and the governance questions raised by AI adoption across the NHS. The episode is relevant to legal, compliance and regulatory professionals who work on medicines promotion or oversee the use of AI in their business.