23rd January 2026 Update

Artificial Intelligence (AI)

EU

• The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have published a set of guiding principles of good AI practice in drug development, aimed at providing guidance on AI use across all phases of the medicine lifecycle. The guidance is also intended to underpin future guidance in specific jurisdictions as well as supporting international collaboration amongst regulators. See here for further information.

Clinical Trials

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) has published a press release highlighting recent data showing a rise in clinical trial applications in the UK between January and November 2025 and highlighting proposed reforms which should make the UK a more competitive place for the conduct of clinical trials.

Code of Practice

UK

• The Prescription Medicines Code of Practice Authority (PMCPA) has published new guidance on package deals, covering classification, governance, written agreements and communication and disclosure of transfers of value. The PMCPA has also advised that companies can direct any questions on the guidance directly to the PMCPA until the end of January and these will be addressed in an on-demand training webinar to be published in February. See here for further information including a link to the guidance.

Competition Law

UK

• The Competition and Markets Authority (CMA) has launched a call for evidence to review its approach to merger efficiencies. See press release for further information. The call for evidence is open until 26 February 2026. See here for information on how to contribute.
• The CMA has announced a review of 33 markets remedies (including the pharmaceuticals market) to assess whether they should be removed or amended. The CMA is consulting on these changes and the consultation is open until 2 March 2026. See here and consultation document for further information.
• The CMA has published guidance on how to collaborate with other businesses on green initiatives while complying with competition law. See here for further information.

Critical Medicines

EU

• Following the European Parliament plenary vote on the Critical Medicines Act – see here, The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued a statement setting out its remaining concerns with elements of the adopted text.

Cybersecurity

EU

• The European Commission has proposed a new cybersecurity package to further strengthen the EU’s cybersecurity resilience and capabilities in the face of growing threats. See European Commission press release for further information.

Data Privacy

EU

• The European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) have published a joint opinion on the European Commission’s proposal for the Digital Omnibus on AI. See here for further information.
• The EDPB has published updated documents related to the EU-US Data Privacy Framework, including a framework FAQ and template complaint form. See here for further information.
• The EDPB has adopted a cooperation procedure for authorising ad hoc contractual clauses and standard contractual clauses. See here for further information.

UK

• The Information Commissioner’s Office (ICO) has published updated guidance on international transfers of personal information. See here for further information.

Environmental

UK

• The CMA has published a short guidance to the CMA’s Green Claims Code, detailing what businesses need to know about responsibility for green claims in supply chains. See here for further information.

Intellectual Property

EU

• EFPIA has called for protection of intellectual property rights in the European Health Data Space and has endorsed Digital Europe’s paper on ‘Safeguarding Intellectual Property and Trade Secrets in the European Health Data Space’. See here for further information.
• The EU Intellectual Property Office (EUIPO) has published an update of recent European case law on infringement and enforcement of intellectual property rights. See here for further information.

Regulatory

EU

• The EMA has opened a consultation on investigation and assessment of cardiovascular safety of anticancer medicinal products. The consultation is open until 31 July 2026. See here for further information, including how to contribute to the consultation.
• The EMA has published a concept paper on the development of a guideline for using owner assessment as efficacy parameter. The consultation is open until 30 April 2026. See here for further information, including how to contribute to the consultation.

UK

• The MHRA has updated its Guidance for the Innovative Licensing and Access Pathway. See updated Guidance here

Strategy Policy and Trade

EU

• The EU has signed a historic trade agreement with Mercosur, which will create one of the largest free trade areas in the World, spanning 31 countries. See European Commission press release. EFPIA has also commented on the trade agreement, stating that whilst the agreement includes some progress for the pharmaceutical sector, it could have gone further. See here for further information.

Transparency

UK

• Following a public consultation, the UK government intends to issue new guidance to enhance transparency in financial relationships between the pharmaceutical/medical device industries and the healthcare sector. See government response and consultation outcome here.