16th March 2026 Update

Advertising

UK

• Prescription Medicines Code of Practice Authority (PMCPA) has added two new on-demand webinars to its learning management system covering the recently published package deals and social media guidance. As well as providing an overview of the new guidance the webinars also address questions that have been received by the PMCPA since the guidance was published. See here for further information, including how to access.

Artificial Intelligence (AI)

EU

• The European Commission has published the second draft of the Code of Practice on Marking and Labelling of AI-generated content. See here for further information.

Global

• The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has published a position paper exploring how the pharmaceutical industry may use AI applications in pharmaceutical manufacturing and control. See here for further information.

UK

• The Information Commissioner’s Office (ICO) has published a report in its tech futures series on agentic AI (autonomous systems that act with a high degree of autonomy and proactive decision-making, with limited human supervision). See here for further information.
• The Medicines and Healthcare products Regulatory Agency (MHRA) has published a new article in its blog series, looking at how regulation plays a vital role in setting standards and protecting patients in relation to emerging technologies, such as AI. See Regulation as an Enabler of Innovation for further information.
• The UK government has announced it is creating a new lab to support transformational AI breakthroughs. See here for further information.

Clinical Trials

EU

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a new study conducted by Frontier Economics looking at the economics behind EU targets for clinical trials. See EFPIA press release for further information.
• The European Medicines Agency (EMA) has opened a public consultation on draft guidance on the conduct of clinical trials during public health emergencies. The consultation is open until 30 April 2026. See here for further information.

UK

• The MHRA has published updated guidance on good clinical practice for clinical trials. See here for further information.

Competition Law

EU

• The European Union and the UK have signed the EU-UK Competition Cooperation Agreement, which sets out a framework for cooperation on competition matters. See European Commission press release for further information.

UK

• The Competition and Markets Authority (CMA) has published responses to the Department of Business and Trade working paper on options for reform of noncompete clauses in employment contracts. See here for further information.

Cyber Security

EU

• The European Commission has published for feedback draft guidance to assist companies meeting the obligations of the Cyber Resilience Act (CRA). The consultation is open until 31 March 2026. The CRA came into force in December 2024 and the main obligations under the Act will apply from December 2027. See draft guidance here and European Commission press release here.

Data Privacy

EU

• The European Parliament has published a study analysing the Digital Omnibus Regulation proposal, identifying interlinks and possible overlaps between different legal acts in the field of digital legislation. See here for further information.

UK

• The ICO has opened a consultation on the draft updated guidance on the research, archiving and statistics provisions. The consultation is open until 27 April 2026. See here for further information.

EU Pharma Law Reform

EU

• The Council of the European Union has published the provisional text of the agreement on the reform of the EU pharmaceutical legislation and the new Directive and Regulation. See here for further information.

Joint Working

UK

• The Association of the British Pharmaceutical Industry (ABPI) has published an article on managing conflicts of interest in NHS-industry partnerships. See here for further information.

Manufacturing

UK

• The UK Space Agency, the MHRA, Regulatory Innovation Office and the Civil Aviation Authority have announced they are working collaboratively to set out a pathway for space-manufactured Medicines. UK companies could benefit from a package of measures to support rapid growth of in orbit manufacturing. See press release and joint statement for further information.

Market Access

UK

• National Institute for Health and Care Excellence (NICE) published its first quality standard on rare diseases to coincide with Rare Disease Day on 28 February. See here for further information.
• From April 2026, the UK government is increasing NICE’s cost effectiveness threshold. The Department of Health and Social care (DHSC) has now published the government response to the earlier consultation which sought views on the proposed amendment to the NICE regulations. See here for further information.

Pricing

UK

• The DHSC has published the minutes of VPAG operational review meeting held between the government, NHS England and the ABPI in December 2025. The August 2025 minutes are delayed but will be published in due course. See here for further information. See also ABPI press release.

Rare Diseases

UK

• The DHSC has published the new England Rare Diseases Action Plan 2026. The plan sets out the vision for addressing health inequalities and improving the lives of those living with rare diseases. See here for further information. The ABPI has also published its response to the Plan. See ABPI press release for further information.

Regulatory

EU

• The EMA has published its Human Medicines Highlights for March 2026, setting out information on new medicines recommended for approval and new information on approved medicines. See here for further information.

Research and Development

EU

• The EMA has published a guideline for consultation on the clinical investigation of medicinal products for the treatment of cystic fibrosis. The consultation is open until 31 August 2026. See here for further information, including how to contribute to the consultation.

Safety

UK

• The MHRA has published its safety roundup for February 2026. See here for further information.

Supply Chain

UK

• The MHRA has published new guidance on strengthening supply chain cyber security and is inviting current and former suppliers to join Risk Ledger and complete a security profile to strengthen supply chain cyber security. See here for further information.

Urban Wastewater Treatment Directive (UWWTD)

EU

• EFPIA and other bodies representing the cosmetics and pharmaceutical sectors have called on the Ministers of Economy to request that the European Commission pauses the implementation of the Extended Producer Responsibility scheme under the UWWTD. They are urging Ministers to conduct proper and robust science-based studies to appropriately assess the real evidence impact on the concerned sectors with a view to revising the Directive. See EFPIA press release for further information.