12th January 2026 Update

Advertising

UK

• The Medicines and Healthcare products Regulatory Authority (MHRA) has published its advertising investigations for December following investigations into complaints about advertising for licensed medicines. See here for further information.

Artificial Intelligence (AI)

EU

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a report of industry perspectives on how AI governance can be successfully integrated into medicinal product research and development. See here for link to the report ‘AI Across the Medicines Lifecycle’
• The European Medicines Agency (EMA) and the Food and Drug Administration (FDA) have jointly identified ten principles for good artificial intelligence practice in the medicines lifecycle. See here for further information.

UK

• The MHRA is seeking evidence on the regulation of AI in healthcare to inform recommendations of the National Commission into the Regulation of AI in Healthcare. The call for evidence is open until 2 February 2026. See here and here for further information including how to contribute to the call for evidence.

Biotech Act

EU

• The European Commission has adopted a proposal for the Biotech Act to establish a framework of measures to strengthen the biotechnology and biomanufacturing sectors. See proposal and European Commission press release for further information. EFPIA has also released a statement on the proposal. See here for further information.

Clinical Trials

UK

• The MHRA has published guidance on the Clinical Trials Regulations enforcement provisions, which explains that the provisions against which an infringement notice or an offence can be raised under the amended Regulations have been extended. See MHRA Guidance
• The MHRA has published guidance on archiving and retention of clinical trial records, including transitional provisions. See here for further information.
• The MHRA has updated its guidance on the common issues with validation and assessment of clinical trial applications and how to avoid them. See here for the updated guidance.
• The MHRA has updated its guidance on other aspects of clinical trials including, collection, verification and reporting of safety events, clinical trials that include an in vitro diagnostic device, labelling, and modifying a clinical trial approval. For further information on recent updates, see the MHRA clinical trials hub here
• The MHRA has published guidance to provide information on how to comply with International Council for Harmonisation (ICH) E6R3 Annotations. See here for further information.

Competition Law

Belgium

• The Belgium Competition Authority has opened proceedings against IQVIA for possible abuse of dominant position in the sector of collection and processing of pharmaceutical data. See here for further information.

Critical Medicines

EU

• On 15 December 2025 the European Parliament Public Health Committee (SANT) adopted its report on the Critical Medicines Act. Parliament’s position is expected to be adopted during January 2026, after which negotiations with EU governments will begin. See European Parliament press release and EFPIA press release for further information.

Data Privacy

EU

• New EU GDPR enforcement rules (Regulation (EU) 2025/2518) were published in the Official Journal in December. These establish procedural rules for cross-border enforcement of GDPR. The Regulation applies from 2 April 2027. See here for further information.

UK

• The Information Commissioner’s Office (ICO) and the Government have signed a Memorandum of Understanding setting out the Government’s commitment to raise data protection standards. See here for further information.
• On 19^th December the European Commission renewed two adequacy decision for the UK. See here for further information.

EU Pharmaceutical Law Reform

EU

• A provisional agreement has been reached on the EU’s pharmaceutical policy framework. See European Parliament press release for further information. Both the European Commission and the EMA welcomed the agreement on the reform. See here and EFPIA has also commented, indicating that it does not consider the proposed legislation will go far enough to drive European competitiveness. See EFPIA press release here

Intellectual Property

UK

• The Intellectual Property Office (IPO) has updated the section of its Manual of Patent Practice regarding Supplementary Protection Certificates for Medicinal Products. See IPO press release for further information.
• The UK government has published updated NHS Intellectual property guidance. See here for further information.

Manufacturing

EU

• The EMA has published a consultation on the revision of Annex 3 of the guidelines on Good Manufacturing Practice for radiopharmaceuticals. See here for further information. The consultation is open until 15 February 2026.

Market Access

UK

• The government has announced that the 2026 payment rate for newer medicines under the Voluntary Scheme for Branded Medicines Pricing and Access (VPAG) will be 14.5 %. See Department of Health and Social Care press release for further information. See also the press release of the Association of the British Pharmaceutical Industry (ABPI) here

Medical Devices

EU

• The European Commission has published its proposal for a regulation to simplify rules on medical devices and in vitro medical devices. See here for further information.

UK

• The MHRA has updated its guidance on clinical investigations for medical devices, which explains when to notify the MHRA of your intention to carry out a clinical investigation for medical devices. See here for further information.
• The MHRA has published the guidance for an in vitro diagnostic roadmap, which sets out timelines and deliverables to support the development of in vitro diagnostic medical devices. See here for further information.
• The MHRA has published guidance for health institutions that manufacture general medical devices under the Health Institution Exemption. See here and here for further information.

Packaging and Labelling

UK

• Following a comprehensive review, the MHRA has announced that warnings on the packaging and patient information leaflets for certain medicines used to treat neuropathic pain, anxiety and insomnia will now carry enhanced warnings. See here for further information.

Quality

EU

• The European Commission has published a draft implementing Regulation laying down certain quality management and procedural requirements for the conformity assessment activities carried out by a notified body under the Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation. See here for further information.

Radiopharmaceuticals

EU

• The EMA has opened a consultation on a draft guideline on quality of radiopharmaceuticals. The consultation is open until 30 April 2026. See here for further information.

Regulatory

EU

• The EMA has opened a consultation on the guideline revision on good pharmacogenomic practice. The consultation is open until 31 March 2026. See here for further information.
• The EMA has opened a consultation on a guideline on general considerations for patient preference studies. The consultation is open until 12 April 2026. See here for further information.
• The EMA has published its Human Medicines Highlights for December including information on approved medicines and new medicines recommended for approval. See here for further information.

Safety

UK

• The MHRA has published its Safety Roundup for December. See here for further information.

Strategy Policy and Trade

UK

• The UK and Singapore have launched a new regulatory innovation corridor to fast track the most promising healthcare innovations. The new collaboration promises a coordinated pathway to allow developers to engage with both regulators at the same time. See here for further information.

Urban Wastewater Treatment Directive (UWWTD)

EU

• Following publication of the European Commission’s Environmental Omnibus package, EFPIA has commented on and expressed disappointment that calls from industry to include the UWTTD have been disregarded. See here for further information.