20th February 2026 Update

Advertising

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) has published its decisions following investigations into complaints about advertising for licensed medicines for January 2026. See here for further information.

Artificial Intelligence (AI)

EU

• The European AI Office has convened its first meeting of the signatory taskforce for the General-Purpose AI Code of Practice to facilitate coherent application of the Code. See here for further information.

UK

• The UK’s largest public research funder, UKRI has published its first AI Research and Innovation Strategic Framework. See UKRI press release and Strategic Framework for further information and press release from the Department of Science Innovation and Technology (DSIT).

Clinical Trials

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on Clinical Trials Regulations: transitional arrangements. See here for further information.
• The MHRA has published updated guidance on Clinical trials for medicines: modifying a clinical trial approval. See here for further information.
• The PATHWAYS puberty blocker clinical trial has been paused after concerns around safety and wellbeing of the trial participants. See MHRA press release, HRA press release, and Department of Health and Social Care (DHSC) press release for further information.

Competition Law

EU

• The European Commission has closed its investigation into alleged anticompetitive behaviour of Edwards Lifesciences. The closure follows the withdrawal of Edwards so called anti-copycatting policy. See European Commission press release for further information.
• The Romanian High Court has made a referral to the Court of Justice of the European Union (CJEU) requesting clarification of when joint lobbying activities of immunoglobulin suppliers amounts to a breach of EU competition laws. The Romania Competition Authority had imposed fines of €71 million on the suppliers for allegedly working together to pressure the government not to apply a clawback tax. The suppliers appealed the decision and the Romanian High Court has requested clarification from the CJEU of the legal standard and burden of proof required to determine when there has been a violation of competition laws. The case raises important questions for the wider pharmaceutical industry who often engage in collective lobbying activities to raise issues with public authorities. See Case C-793/25 for further information but note that full details of the specific questions referred by the Romanian Court are not yet publicly available.

Cybersecurity

UK

• The UK government has launched its “Lock the Door” campaign aimed at providing practical cybersecurity guidance to help businesses defend against online threats. See DSIT press release for further information.

Data Privacy

EU

• The European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) have adopted a joint opinion on the Digital Omnibus Regulation proposal and have identified that some of the proposals raise significant concerns, including the definition of personal data. See the joint EDPB and EDPS press release for further information.
• The EDPB has identified challenges to the full implementation of the right to erasure and has adopted a report on its Coordinated Enforcement Framework action on the right to be forgotten. See here for further information.
• The EDPB has published its work programme for 2026-2027. The programme reaffirms the commitment of the EDPB to simplify GDPR compliance for organisations. See here for further information.
• In a landmark ruling published on 10 February 2026 (Case C-97/23P) the CJEU has confirmed that binding decisions of the EDPB can be directly challenged before the EU courts. See here for further information.

UK

• The Information Commissioner’s Office (ICO) has won its appeal against the decision of the Upper Tribunal on DSG Retail Limited (DSG). The Court of Appeal ruling confirms that DSG were required to take appropriate security measures to protect personal data from unauthorised access and the decision reinstates the interpretation of the legal responsibility of organisations to keep personal data secure. See Judgement in DSG Retail Limited v The Information Commissioner for further information.

Intellectual Property

UK

• The Intellectual Property Office (IPO) has shared its roadmap for launching its OneIPO patents service, which will upgrade existing services. See IPO press release for further information.

Manufacturing

EU

• The European Medicines Agency (EMA) has published a concept paper for consultation on the revision of the guidelines on Good Manufacturing Practice for medicinal products – Annex 15 – Qualification and Validation. The consultation is open until 9 April 2026. See here for further information including how to contribute to the consultation.
• The EMA has published a concept paper for consultation on the revision of the guidelines on Good Manufacturing Practice for medicinal products – Annex 6 – Manufacture of Medicinal Glass. The consultation is open until 11 April 2026. See here for further information including how to contribute to the consultation.

Market Access

UK

• National Institute for Health and Care Excellence (NICE) has issued new guidance for type 2 diabetes treatment, which will see millions of people able to access an SGLT-2 inhibitor for the first time. See NICE press release for further information.
• The MHRA has published guidance on the Integrated Scientific Advice service from the MHRA and NICE. The service provides pharmaceutical companies with coordinated scientific advice on evidence requirements for market authorisation and health technology assessment, through a single process. See here and here for further information.

Medical Devices

UK

• The MHRA has launched a consultation on indefinite recognition of CE-marked medical devices. The consultation is open until 10 April 2026. See here and here for further information including how to contribute to the consultation.
• The MHRA has published guidance on timelines for acceptance of CE marked medical devices in Great Britain. See here for further information.

Pharmacovigilance

EU

• The EMA has published a concept paper for consultation on the revision of the guideline on veterinary good pharmacovigilance practices Module: Signal Management (EMA/522332/2021). The consultation is open until 15 March 2026. See here for further information including how to contribute to the consultation.

UK

• On 12^th February 2026 amendments to the EU Commission Implementing Regulation (CIR) 520/2012 came into effect. The MHRA has now published guidance to clarify expectations on the application of the further pharmacovigilance provisions set out in CIR 520/2012 for UK authorised products. See here for further information.

Pricing

UK

• The DHSC has proposed a 2026 repayment rate of 16.5% for the statutory scheme for branded medicines, representing a significant decrease from the 2025 rates. The proposal is designed to maintain broad equivalence with the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG). The DHSC has opened a consultation on its proposals which is open until 21 April 2026. See here for further information, including how to contribute to the consultation.

Regulatory

EU

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) in association with AESGP and Medicines for Europe has published a comprehensive overview of electronic Product Information (ePI) pilot projects conducted across 31 countries. The report shows the progress made in implementing ePI and the importance of sharing best practice. See EFPIA press release for further information.

Research and Development

UK

• The Association of the British Pharmaceutical Industry (ABPI) and the National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs) have published a major review examining the UK’s capabilities in developing human-relevant pre-clinical models for medicine development. See ABPI press release for further information.

Supply Chain

EU

• The European Commission has adopted an ICT supply chain security toolkit, aimed at mitigating cybersecurity risks of ICT supply chains. See European Commission press release for further information.

Training

UK

• The MHRA has published details of two training webinars (Clinical Trials Regulations: Countdown to Implementation – 12 March 2026 and Aligned Decisions: faster patient access webinar – 25 March 2026). See here for further information including details of how to register for both events.

Urban Wastewater Treatment Directive

EU

• The General Court has dismissed EFPIA’s action for annulment of the Urban Wastewater Treatment Directive on the grounds of lack of legal standing. EFPIA confirms it will continue to challenge the Directive on the grounds that the current proposals are not in accordance with core EU principles. See EFPIA press release for further information.