Data protection essentials

HRA launches strategy to boost UK life sciences and streamline research

The Health Research Authority (HRA) has launched a new three-year strategy, to support the UK government’s health and economic growth missions. The strategy aims to make the UK the easiest place to conduct trusted health and social care research by enhancing digital infrastructure, embedding productivity, reducing regulatory burden, and building public trust. It aligns with the 10 Year Health Plan’s ambitions to accelerate clinical trials, increase research access, and improve NHS sustainability.

Life Sciences weekly highlights—10 July 2025

This week's edition of Life Sciences weekly highlights includes news that the Commission launched a new strategy to make Europe a global leader in life sciences by 2030, the government has published its 10 Year Health Plan for England, with ambitions to accelerate clinical trials, increase research access, and improve NHS sustainability, and key life sciences bodies have responded to the plan, including the Health Research Authority, which has also launched a new three-year strategy to support the government’s 10 Year Health Plan for England. Also included, is news that the EMA published its third annual report on its Real-World Evidence framework, covering February 2024–February 2025, the MHRA launched a consultation on the International Council for Harmonisation (ICH) E21 guideline regarding the inclusion of pregnant and breastfeeding individuals in clinical trials, the Commission adopted Implementing Decision (EU) 2025/1324, amending the 2019 framework regarding medical device expert panel rules and establishing a new expert panel for paediatrics and rare diseases, as well as news that the EFPIA published a position paper responding to the EU Critical Medicines Act, the DHSC announced plans for new legislation requiring healthcare providers to contribute to a single patient record system, and the ASA has found an Instagram post promoting weight loss medication in breach of the CAP Code for promoting prescription-only medicines (POMs) to the public, in a ruling that forms part of a wider body of work on POMs used for weight loss, among other stories.

Commission fines Alchem for role in drug ingredient price-fixing cartel

The European Commission has found Achem guilty of participating in a drug ingredient cartel for more than a decade after the drugmaker previously chose not to settle in an investigation. It has fined alchem 489,000 Euros after finding that the company had illegally fixed the price of an API known as N-Butylbromide Scopolamine/Hyoscine (‘SNBB'), an important input material to produce the abdominal antispasmodic drug Buscopan and its generic versions. In addition, Alchem exchanged commercially sensitive information. This has been the first cartel that the Commission sanctioned in the pharmaceutical sector and in relation to an active pharmaceutical ingredient. The Commission cooperated and coordinated certain investigative activities with the Swiss and Australian competition authorities.

Commission consults on updates to EudraLex Volume 4 GMP guidelines

The European Commission has launched a consultation on proposed updates to EudraLex Volume 4: Good Manufacturing Practice (GMP) guidelines. Feedback is invited on the draft revision of Chapter 4 (Documentation), Annex 11 (Computerised Systems), and the draft introduction of a new Annex 22 (Artificial Intelligence). In light of the rapid advancement of digital technologies and the implementation of AI systems in pharmaceutical manufacturing, the update of the GMP guidelines is considered necessary to ensure they continue to provide clear, practical and relevant guidance for manufacturers and national competent authorities. Annex 22 introduces requirements for the selection, validation, and oversight of AI models used in critical GMP applications, with emphasis on data integrity, explainability, and human-in-the-loop controls. The use of dynamic models and generative AI, including large language models (LLMs), is excluded from critical GMP use. Responses are sought by 7 October 2025.