Our Industry Update Newsletter returns for the final update of 2025.
As always, this quarter’s update has been expertly compiled by Christina Hägglund, QA Manager.
PHARMACEUTICAL REGULATIONS
EU Clinical Trial Regulation (CTR) (EU No. 536/2014)
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines
Agency (EMA) have issued a detailed report on clinical trial applications and the characteristics of clinical
trials in the EU/European Economic Area during the 3-year CTR transition period, which ended
30-Jan-2025. EU clinical trials during the 3-year CTR transition period
A new clinical trial map is accessible via Clinical Trials Information System (CTIS) and gives
comprehensive and current information on 10,000 EU clinical trials. Clinical Trials Information System |
European Medicines Agency (EMA)
EU Pharmacovigilance Regulation
Pharmacovigilance (PV) in the EU is regulated by Regulation (EC) No. 726/2004 for EU-authorised
medicinal products and by Directive 2001/83/EC for nationally authorised medicinal products.
The Implementing Regulation (EU) No. 520/2012, which outlines practical details for MAH, national CA
and the EMA has been updated to “Implementing Regulation (EU) No. 2025/1466” and became effective
22-Jul-2025.
Implementing Regulation (EU) No. 2025/1466 aims to harmonise PV activities by Marketing
Authorisation Holders, national Competent Authorities and the EMA. Commission Implementing
Regulation (EU) 2025/1466
Health Technology Assessment (HTA) Regulation
On 05-Sep-2025, the EC issued a Frequently Asked Questions (FAQ) document to clarify HTA Regulation
((EU) 2021/2282). The FAQ will be maintained and updated on a regular basis. b81a42c4-b2ba-47bc-
b807-0c667c8de32e_en
UK Upcoming Clinical Trial Regulation
The new Clinical Trial Regulation comes into effect in the UK on 28-Apr-2026 and is the most significant
update to UK clinical trial regulations in two decades.
The Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority
(HRA) have developed regulations that are shaped by – and will benefit – patients, researchers, health
professionals and industry.
The MHRA has published 10 guidance documents to support sponsors to prepare for the new legislation.
Medicines: clinical trials hub – GOV.UK Additional training material is available on the MHRA inspectorate
blog ‘6-month countdown’. Clinical trials regulations: six-month countdown begins – MHRA Inspectorate
Under the new Regulation, substantial modifications can be granted automatic approval through the
Route B substantial modification process, provided certain eligibility criteria are met. On 01-Oct-2025,
the MHRA launched a 6-month pilot scheme to help sponsors prepare for this. New regulations for
clinical trials – Join our Route B substantial modifications pilot – MHRA Inspectorate
ICH GUIDELINES
ICH E6(R3) – Annex 1, Principles and Annex 2
- On 09-Sep-2025, the US Food and Drug Administration (FDA) published a final guidance for
‘E6(R3) Good Clinical Practice’. E6(R3) Good Clinical Practice (GCP) | FDA - In October 2025, ICH began publishing training material for E6(R3). Module 1, which is in three
parts, is the first such training and is found under ‘E6(R3) Training Materials’. ICH Official web
site : ICH - Accelerating Clinical Trials in the EU (ACT EU) has published a report following a workshop
exploring the major changes of ICH E6(R3) Principles and Annex 1, in particular Sponsor (and
Investigator) Oversight and Data Governance requirements. ACT EU workshop report on ICH E6
R3 - ICH E6(R3) Annex 2 will provide GCP considerations for non-traditional interventional clinical
trials, including trials using Real World Data (RWD) and decentralised designs. There is a delay
in the finalisation and adoption process and the guideline remains at step 3. ICH Official web
site : ICH
ICH E20 Guideline
On 25-Jun-2025, ICH E20 Guideline ‘Adaptive Designs for Clinical Trials’ reached Step 2b and has been
issued for public consultation in the ICH regions:
ICH_E20EWG_Step3_DraftGuideline_2025_0625_0.docx and in the US: download
ICH E14 Guideline
On 04-Sep-2025, ICH M14 Guideline ‘General Principles on Planning, Designing, Analysing and Reporting
of Non-interventional Studies that Utilise Real-World Data for Safety Assessment of Medicines’ reached
Step 4 and has entered the Step 5 implementation phase.
ICH_M14_Step4_Final_Guideline_2025_0905.pdf
ICH E2D(R1) Guideline
On 15-Sep-2025, ICH adopted E2D(R1) Guideline ‘Post-Approval Safety Data: Definitions and Standards
for Management and Reporting of Individual Case Safety Reports’.
ICH_E2D(R1)_Step4_FinalGuideline_2025_0819.pdf
ENHANCED ACCESS TO CLINICAL TRIALS & MEDICINE
World
On 01-Sep-2025, the EMA and World Health Organisation (WHO) published an overview of key
initiatives and interactions following 10 years of collaboration in advancing global access to medicines.
EMA-WHO collaboration and partnership
The Association of the British Pharmaceutical Industry (ABPI) and the Association of Medical Research
Charities (AMRC) have met to discuss the challenges of ensuring diverse and under-represented
populations are included in clinical research. This was a UK meeting, but their proposals apply globally.
abpi_amrc_airc_report_v06.pdf
EU
To overcome geographical barriers, the EU-X-CT initiative looks at the challenges faced by sponsors,
investigators and potential participants seeking to engage in EU cross-border clinical trials. The
recommendations address many of the complex issues relating to accessing clinical trials in a country
other than the participants’ home country. EU-X-CT – Recommendations – Version 1.0 – 17 June 2025.pdf
UK
The UK’s National Institute for Health and Care Research (NIHR) has signed a joint statement with more
than 40 major UK research funders committing to encouraging inclusion of older adults in research.
Statement of intent: Integrating older age into health and care research | NIHR
The MAPLE project aims to reduce the exclusion of clinical trial participants with a lower English
language literacy. MAPLE
On 31-Jul-2025, the MHRA described how it will enable earlier access to innovative medical devices that
address unmet clinical needs within the NHS and that show a clear benefit to patients. The policy will
support investment in a new Early Access service, which will provide time-limited conditional access to
promising technologies ahead of full regulatory approval. MHRA outlines intent to speed up patient
access to innovative medical devices – GOV.UK
On 06-Aug-2025, the MHRA and the National Institute for Health and Care Excellence (NICE) described
how their 10 Year Health Plan will lead to faster access to medicines. Patients will receive medicines 3-6
months faster under 10-Year Health Plan, as regulators set out plans – GOV.UK
PUBLICATIONS, ARTICLES AND GUIDANCE
WORLD
- On 07-Oct-2025, WHO launched the Global Clinical Trials Forum (GCTF). The GCTF supports the
implementation of WHO’s Guidance for Best Practices for Clinical Trials. WHO launches the
Global Clinical Trials Forum - The EMA is calling for increased global awareness of antimicrobial resistance: Antimicrobial
resistance | European Medicines Agency (EMA); antimicrobial-resistance-act-now-protect-our-
present-secure-our-future_en.pdf and Podcast Podcast: Inside EMA | European Medicines
Agency (EMA)
EU
- The EMA has published its third annual report on using Real World Evidence (RWE) framework
to support the EU regulatory decision-making process. Real-world evidence framework to
support EU regulatory decision-making - The EMA has issued a draft reflection paper on Patient Experience Data (PED) and has opened
a public consultation, ending 31-Jan-2026. Patient experience data (PED) reflection paper |
European Medicines Agency (EMA)
USA
- In June 2025, the FDA issued final guidance entitled ‘Conducting Remote Regulatory
Assessments [RRAs] – Questions and Answers’. Guidance for Industry: Conducting Remote
Regulatory Assessments – Questions and Answers - On 16-Jul-2025, the FDA released new draft guidance entitled ‘Development of Cancer Drugs
for Use in Novel Combination – Determining the Contribution of the Individual Drugs’ Effects’.
Development of Cancer Drugs for Use in Novel Combination – Determining the Contribution of
the Individual Drugs’ Effects | FDA - On 23-Jul-2025, the FDA’s Center for Drug Evaluation and Research (CDER) released a White
Paper encouraging the adoption of Selective Safety Data Collection (SSDC), referencing the
International Council for Harmonisation E19 Guideline. Selective Safety Data Collection (SSDC)
Demonstration Project | FDA - On 19-Aug-2025, the FDA issued draft guidance ‘Approaches to Assessment of Overall Survival
[OS] in Oncology Clinical Trials’. 2025-15796.pdf - On 22-Aug-2025, the FDA began a daily publication of adverse event (AE) data from the FDA
Adverse Event Reporting System (FAERS). This is part of FDA’s commitment to modernising
safety monitoring, transparency and real-time protection of public health. FDA Begins Real-Time
Reporting of Adverse Event Data | FDA - In September 2025, the FDA issued draft guidance entitled ‘Safety Labeling Changes –
Implementation of Section 505(o)(4) of the FD&C [Federal Food, Drug, and Cosmetic] Act’.
Safety Labeling Changes-Implementation of Section 505(o)(4) of the FD&C Act - On 11-Sep-2025, the FDA issued a draft guidance ‘Development of Non-Opioid Analgesics for
Chronic Pain’. Development of Non-Opioid Analgesics for Chronic Pain | FDA - On 15-Sep-2025, the FDA published an article on the Development and Use of Office of New
Drugs Custom Medical Queries for Safety Analyses of Clinical Trial Data. The Development and
Use of Office of New Drugs Custom Medical Queries for Safety Analyses of Clinical Trial Data –
PubMed
UK
- In September 2025, the HMRA published ‘Standardised Format for Medical Devices Post-Market
Surveillance Report’.
Medical_devices_Standardised_format_for_the_post_market_surveillance_report.pdf
ARTIFICIAL INTELLIGENCE (AI) IN HEALTHCARE
AI in Scientific Research
On 08-Oct-2025, the EC’s Joint Research Centre (JRC) published a report to provide a foundation for
future European policy on AI in science. JRC Publications Repository – The Role of Artificial Intelligence
in Scientific Research
UK Improve on Approval Times
New published data shows that the UK MHRA’s risk-proportionate approach to authorising clinical trial
applications is delivering many decisions ahead of the statutory timelines. Digital innovation, AI and risk-
proportionate oversight mean that lower-risk studies can move ahead without unnecessary delay, while
higher-risk trials still receive the detailed expert review they require. UK clinical trial approval times
twice as fast with AI and reforms – GOV.UK
New UK Commission to Accelerate AI use in the NHS
A new rule book for AI in Healthcare, is due to be published in 2026. A new National Commission has
been set up to provide AI advice for MHRA and aim for the NHS to gain quicker access to the latest AI
tools. New Commission to help accelerate NHS use of AI – GOV.UK
You can download a pdf of this update here and sign up to receive our updates via email 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