Digest: October 2025 Featured news that matters in medical writing and communications
The newsletter provides a summary of the recent news or key updates in the field of medical writing and relevant for our business activities. Information is selected from various sources such as the EMWA, AMWA, ICH, EMA, US FDA, and European Commission websites. We hope you find the newsletter informative!
ICH Guidelines
ICH M14 Guideline on General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilise Real-World Data for Safety Assessment of Medicines reached Step 4 of the ICH process. This guideline provides recommendations and a harmonized framework for planning, designing, analyzing, and reporting non-interventional pharmacoepidemiological studies that generate real-world evidence for post-marketing safety submissions. It includes a section on protocol development recommendations. A presentation is available on the ICH website (https://www.ich.org/page/multidisciplinary-guidelines#14-1).
CTR & CTIS
The European Medicines Regulatory Network published a report about clinical trial applications (CTAs) submitted to CTIS during the transition period between 31 January 2022 (CTR entered into effect) and 30 January 2025 (deadline for ongoing trials to transition to CTIS). Between 31 January 2023 (CTIS mandatory for new CTAs), and 30 January 2025, an average of 200 new initial CTAs were submitted every month to CTIS; of which approximately 80 applications were for multinational clinical trials. The full report is available at https://www.ema.europa.eu/en/news/new-targets-clinical-trials-europe.
EMA News
The EMA has published a recording of the Accelerating Clinical Trials in the EU (ACT EU) workshop on ICH E6 R3 principles and Annex 1 that took place back in February 2025. The workshop report is available at https://www.ema.europa.eu/en/events/act-eu-workshop-ich-e6-r3-principles-annex-1.
US FDA Drugs & Biologics News
The US Food & Drug Administration (FDA) announced real-time release of complete response letters (CRLs) and posted a previously unpublished batch of 89. “Going forward, the agency will promptly release newly issued CRLs, and when approving applications will release all CRLs associated with that application. The agency will also publish batches of previously issued CRLs associated with withdrawn or abandoned applications. All CRLs will be redacted to remove confidential commercial information, trade secrets, and personal private information, but will contain company names.” The FDA news release can be found at https://www.fda.gov/news-events/press-announcements/fda-announces-real-time-release-complete-response-letters-posts-previously-unpublished-batch-89.
The US FDA published the following final guidance document E6 (R3) Good Clinical Practice, which is the adoption of the ICH E6 (R3) guideline.
Transparency & Disclosure
Recordings of the 12 presentations held over the 3 days of the PHUSE Data Transparency Autumn Event (16–18 September 2025) are available at https://www.phuse-events.org/attend/frontend/reg/thome.csp?pageID=65236&eventID=101&traceRedir=4.
Medical Devices
The MDCG subgroup (Borderline and Classification Working Group) released an updated manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (version 4) (https://health.ec.europa.eu/latest-updates/update-manual-borderline-and-classification-under-regulations-eu-2017745-and-2017746-september-2025-2025-09-12_en).
EUDAMED
The European Commission is organizing free hybrid workshops to support onboarding to EUDAMED. These workshops provide an overview of the obligations under the Medical Devices Regulations: Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The next one is scheduled on 03 December 2025. Further details are available at https://www.eap-events.eu/ehome/index.php?eventid=200291348&.
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