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
- The World Health Organisation (WHO) has designated a Dutch University Digital Ethics Centre as their Collaborating Centre on Artificial Intelligence (AI) for health governance. WHO announces new collaborating centre on AI for health governance
EU
- The European Medicines Agency (EMA) has published a draft reflection paper on a tailored clinical approach in biosimilar development and assessment in the EU. The aim is to reduce the amount of clinical data required thus simplifying the development and evaluation process. Reflection paper on a tailored clinical approach in biosimilar development
- The European medicines agencies network has published its:
- Strategy up to 2028 European medicines agencies network strategy | European Medicines Agency (EMA)
- Clinical evidence vision by 2030 EUROPEAN MEDICINES AGENCY – Clinical evidence vision for 2030
UK
- On 9 April 2025, the WHO confirmed the successful redesignation of Medicines and Health products Regulatory Agency’s (MHRA’s) Science and Research group as one of its Collaborating Centres for the Standardisation and Evaluation of Biologicals for the next four years. World Health Organization confirms MHRA to continue playing vital role in ensuring the quality of global biological medicines – GOV.UK
- In March 2025, the seven new Centres of Excellence for Regulatory Science and Innovation (CERSIs) met in London together with sponsors and key representatives. The CERSIs leads described their progresses since the launch earlier in the year and discussions centred around five topics:
- AI and medical technology (safe development and integration of AI-powered tools within the wider healthcare system)
- In silico trials (explore new approaches while maintaining safety)
- Pharmacogenomics and diagnostics (shift healthcare from sickness to prevention)
- Cell and gene therapies (share laboratory approaches for advanced therapies)
- Modernising manufacture (use of new digital tools in production).
- MHRA showcases next phase of regulatory science to bring innovative treatments to patients sooner – GOV.UK
USA
- The Food and Drug Administration (FDA) is to phase out animal testing for several drug classes. FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs | FDA
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.
- Annex 2 addresses the GCP considerations that arise from using diverse design elements and data sources, including decentralised clinical trials and Real World Data. One of the challenges is the continual evolvement of the clinical trial environment. ICH E6(R3) Guideline for good clinical practice – Annex 2_Step 2b and ICH Official web site : ICH
Updated Draft ICH Guidelines and supporting documents
- M13B ‘Bioequivalence for Immediate-Release Solid Oral Dosage Form’ Providing recommendations for obtaining waivers of bioequivalence studies. M13B Final Draft Guideline
- M11 ‘Clinical electronic Structured Harmonised Protocol (CeSHarP)’ Introducing a protocol template and technical specification, for uniform protocols that use harmonised data exchange format, acceptable to the regulatory authorities. ICH M11 guideline, clinical study protocol template and technical specifications – Scientific guideline | European Medicines Agency (EMA)
- ‘ICH eCTD (electronic Common Technical Document) v4.0 Implementation Guide Package’ and Q&A document v1.9 are available. ICH Official web site : ICH
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
- WHO ‘Guidance for best practices for clinical trials’ Guidance for best practices for clinical trials
- May 2025 – WHO Member States will submit a proposed draft Pandemic Agreement for consideration by the World Health Assembly. WHO Member States conclude negotiations and make significant progress on draft pandemic agreement
EU
- April 2025 – Catalogues of Real World Data Sources and Studies Homepage | HMA-EMA Catalogues of real-world data sources and studies
- April 2025 – Guidance on Good Manufacturing Practice and Good Distribution Practice – updated Q&A document Guidance on good manufacturing practice and good distribution practice: Questions and answers | European Medicines Agency (EMA)
- EMA ‘Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials’ becomes effective on 01 July 2025. Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials
- European Commission (EC) resources on rare diseases:
UK
- April 2025 – Guidance on the MHRA’s national assessment procedure for marketing authorisation applications. National assessment procedure for medicines – GOV.UK
- February 2025 – MHRA Guidance on ‘Digital mental health technology: qualification and classification’. Digital mental health technology: qualification and classification – GOV.UK
USA
- March 2025 – FDA published two case studies and a user guide for the design and conduct of rare disease drug development programmes. Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) | FDA
- February 2025 – FDA Information Sheet ‘Institutional Review Boards (IRB) Frequently Asked Questions’ Institutional Review Boards Frequently Asked Questions | FDA and ‘IRB Written Procedures’ Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs
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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