Our Industry Update Newsletter returns for the second update of 2025.

As always, this quarter’s update has been expertly compiled by Christina Hägglund, QA Manager.

INITIATIVES

World

EU

UK

USA

REGULATION & ICH GUIDELINES

EU – Regulation on the European Health Data Space (EHDS)

The Regulation, which came into force 26 March 2025, is an important milestone in EU’s efforts to build a secure and efficient digital health ecosystem as part of the European data strategy.

The EHDS will provide a comprehensive framework for the access to and use of electronic health data across Member States. Regulation – EU – 2025/327 – EN – EUR-Lex

UK – Medicines for Human Use (Clinical Trials) (Amendment) Regulation 2024

The 12-month implementation period has begun and this Regulation will become effective on 10 April 2026, which is around the same time as UK’s implementation of ICH E6(R3).

The new Regulation represents the biggest overhaul of clinical trial regulations in the UK for 20 years and aim to:

  • Strengthen patient safety
  • Accelerate approvals
  • Enable innovation and help more people benefit from taking part in vital clinical research
  • Ensure the UK remains competitive for the conduct of clinical trials.

Clinical Trials regulations signed into law – GOV.UK

UK – Human Medicines (Amendment) (Modular Manufacture and Point of Care)
Regulations 2025, Statutory Instrument (SI) 2025 87

This regulation will introduce changes for the manufacture of medicines at – or close to – the point of patient care. Point of Care (POC) and Modular Manufacture (MM) are collectively called Decentralised Manufacture (DM).

DM processes allow medicinal products to be made at or close to a patient’s location for administration of the medicine. This new regulation, which comes into effect 23 July 2025, will assist in enabling DM.

Decentralised manufacture hub – GOV.UK

ICH E6(R3) Guideline for Good Clinical Practice

ICH E6(R3) Principles and Annex 1 reached step 4 of the ICH process on 06 January 2025.

In recent months, public consultation across the ICH region for Annex 2 has taken place. The Expert Working Group Annex 2 Sub-group will review all the comments and submit a (Step 3) Expert Draft Guideline to be considered for adoption.

Updated Draft ICH Guidelines and supporting documents

CLINICAL TRIALS INFORMATION SYSTEM (CTIS)

CTIS Becomes a WHO Primary Registry

The WHO has designated CTIS as a primary registry platform for international clinical trials. CTIS has been a registered data provider for WHO since May 2023.

Becoming a primary registry means CTIS adheres to specific criteria for content, data quality and validity, accessibility, unique identification, technical capacity and administration. Clinical Trials Information System designated as WHO primary registry | European Medicines Agency (EMA)

Map of EU Clinical Trials Accessible via CTIS

In March 2025, the Accelerating Clinical Trials in the EU (ACT EU) initiative launched a map of clinical trials to provide patients and healthcare professionals with easy access to information on clinical trials in the EU. Searches via geographic location and medical condition are possible. New clinical trial map launched in the EU | European Medicines Agency (EMA)

CTIS – updated Data Protection Notice

In February 2025, the Data Protection Notice on CTIS was updated to comply with the requirements of the Clinical Trial Regulation (EU) No. 536/2014.

The data protection notice explains essential details of the processing of personal data in CTIS, including the EU Portal and the EU Database. EMA-TDA-006-DPN-CTIS

Guidance Documents

World

EU

UK

USA

You can download a pdf of this update here and sign up to receive our updates via email here.

If you require support or advice with any issues raised by this latest industry and Clinical Trials update, please contact us here.


Thank you for taking the time to read this Industry Update from S-cubed

Prepared by: Christina Hägglund, QA Manager, S-cubed Ltd Email: christina.hagglund@s-cubed.co.uk



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