17th August 2026 Update

Advertising

UK

• The Prescription Medicines Code of Practice Authority (PMCPA) has ruled that Sanofi has breached the ABPI Code of Practice and brought discredit upon the pharmaceutical industry in two separate cases CASE/0689/08/25 and CASE/0688/08/25. In addition, Sanofi was publicly reprimanded in CASE/0689/08/25. See PMCPA press release and case reports for further information.
  
  
• The PMCPA has ruled that AGB Pharma has breached the ABPI Code of Practice and brought discredit upon the pharmaceutical industry in CASE/0719/09/25. See PMCPA press release here.
  
  
  

Artificial Intelligence (AI)

EU

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•  The AI Omnibus was published in the Official Journal of the European Union on July 24, 2026 and entered into force on 27 July 2026. See European Commission press release for further information.

• From 2nd August 2026, the European Commission and the national authorities will start to enforce the AI Act. New transparency rules will also start to apply from this date. See here for further information.

• The European Commission has updated its FAQs on the transparency obligations under Article 50 of the AI Act. See here for further information.

UK

•  The Medicines and Healthcare products Regulatory Agency (MHRA) launched the London region regulatory sandbox in June 2026. The MHRA is now inviting expressions of interest from AI-enabled medical device manufacturers and NHS provider organisations interested in participating in the Sandbox. See here and here for further information.

Biotech Act

EU

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published its submission to the EU Biotech Act consultation. See here for further information. 

Competition Law

UK

• The Court of Appeal has dismissed the appeals of Auden/Actavis, Allergan and Intas against the Competition Appeal Tribunal’s judgement affirming the Competition and Markets Authority’s (CMA’s) infringement decision. The CMA investigated alleged excessive and unfair pricing, anti-competitive agreements and abusive conduct with respect to hydrocortisone tablets. The appeals relating to penalties have been remitted to the Tribunal for further consideration. See Court of Appeal Judgement, Court of Appeal press summary, CMA update and press release for further information.

   

• The CMA has published the consultation outcome to its general guidance on transparency and disclosure. The updated guidance will take effect from 23 July 2026. See here for response to the consultation and updated guidance.

Cybersecurity

EU

• The European Commission has published new guidance to support businesses’ implementation of the Cyber Resilience Act. See European Commission press release for further information.

   

• On 22 July 2026 the European Union Agency for Cybersecurity (ENISA) signed a contribution agreement with the European Commission to implement the EU Action Plan for the cybersecurity of hospitals and healthcare providers. See here for further information.

• ENISA released updated Procurement Guidelines for Cybersecurity of Hospitals and Healthcare Providers on 22 July 2026. These Guidelines are intended to help medical organisations integrate cyber defences across the entire procurement lifecycle. See here for further information.

UK

• The National Cyber Security Centre has published guidance to help organisations recover from cyberattacks. See here for further information, including the guidance. 

Data Privacy

EU

•  The European Data Protection Board (EDPB) has announced a stakeholder event on the guidelines on the interplay between data protection and competition law. The event will take place on 15 October 2026. For further information and to express interest in participating see here.

Medical Devices

UK

• The MHRA has published Guidance on device qualification and classification of ambient voice technology-enabled products that are medical devices. See here for further information.

  The MHRA has updated its Guidance on device qualification and classification of digital mental health technology. See here for further information.

Packaging

EU

• The EU Packaging and Packaging Waste Regulation (Regulation (EU) 2025/40) (PPWR) becomes generally applicable on 12 August 2026. It applies directly across member states and overhauls sustainability, labelling and chemical safety rules for all packaging entering the EU market. See here for further information. 

Pricing

UK

• The Department for Health and Social Care (DHSC) has published Minutes of the operational review meeting held on 12 August 2025 between the government, NHS England and the ABPI about the 2024 voluntary scheme for branded medicines pricing. See here for further information. 
  
  

Rare Diseases

UK

• The Health Research Authority (HRA) has published its response to the MHRA consultation on the proposed rare disease therapies regulatory framework. See here for further information. 

Regulatory

EU

• The European Medicines Agency (EMA) has published for consultation a concept paper on the update of the Guideline on similar biological medicinal products (CHMP/437/04 Rev.1). The consultation is open until 31 October 2026. See here for further information including how to contribute to the consultation.

   

• The EMA has published for consultation a concept paper on the revision of their guideline on pharmaceutical fixed combination products (EMA/CVMP/83804/2005-Rev.1). The consultation is open until 31 October 2026. See here for further information, including how to contribute to the consultation.

   

• The EMA has published for consultation a concept paper on the development of a reflection paper on the non-clinical requirements for severely debilitating or life-threatening diseases. The consultation is open until 30 September 2026. See here for further information, including how to contribute to the consultation.

   

• The EMA has published its Human Medicines Highlights for August 2026 with information on new medicines recommended for approval and new information on approved medicines. See here for further information.

Safety

UK

• The MHRA has published a Public Assessment Report on the safety review of the available data on the risk of dementia with the use of bladder anticholinergic medicines. See here for further information.

• The MHRA has published its Safety Roundup for July 2026. See here for further information.

   

• The MHRA has published the fifth edition of the MHRA Safety Guidelines for Magnetic Resonance Imaging Equipment in Clinical Use. See here for further information.

Veterinary Medicines

EU

• The EMA has published a draft guideline for consultation on veterinary good pharmacovigilance practices – Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files – Revision 1. The consultation is open until 24 September 2026. See here for further information, including how to contribute to the consultation.