Digest: March 2026 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 M15 Guideline on General Principles for Model-informed Drug Development, which provides recommendations for planning, model evaluation, and documentation of evidence derived from Model-Informed Drug Development, reached Step 4 on 29 January 2026.
ICH developed a mock example to show the potential structure and presentation of information in the revised Modules 2.3 and 3 of the Common Technical Document – Quality. It clarifies how the concepts and organisation proposed in the draft M4Q(R2) Guideline may be applied in practice (https://ich.org/page/ich-m4qr2-mock-ups).
CTR & CTIS
The Clinical Trials Coordination Group (CTCG), an HMA working group of experts from national regulatory agencies on the classification, assessment and oversight of clinical trials, published the 2026-2027 workplan that includes several key topics to strengthen the clinical trial review system in the EU/EEA. Refer to https://www.hma.eu/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/CTCG/CTCG_workplan_2026-2027_Adopted.pdf.
EMA News
EMA published Review of the stepwise paediatric investigation plan (sPIP) pilot: Outcomes and future perspectives. Between 2023 and 2025, EMA received 27 eligibility requests and 8 sPIPs were adopted, mainly in rare diseases and oncology. The sPIP pilot has demonstrated feasibility and utility in regulatory practice, offering a structured and flexible approach to support pediatric drug development. Refer to https://www.ema.europa.eu/en/documents/report/review-stepwise-paediatric-investigation-plan-spip-pilot-outcomes-future-perspectives_en.pdf.
EMA and Head of Medicines Agencies (HMA) published the Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk. For more information, refer to https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/good-pharmacovigilance-practices-gvp.
European Clinical Trials Information Network
The European Clinical Trials Information Network developed a website to help patients discover clinical trials across Europe. Viewers can search for a specific condition or location and learn more about diseases and cutting-edge therapies and innovative treatments (https://clinicaltrials.eu). The service is not affiliated with the European Commission, the EMA, or the official CTIS system.
US FDA News
FDA has published an article entitled “One Pivotal Trial, the New Default Option for FDA Approval — Ending the Two-Trial Dogma” in NEJM (authors Vinay Prasad and Martin A. Makary); available at https://www.nejm.org/doi/full/10.1056/NEJMsb2517623. RAPS regulatory focus article reports on how experts have reacted to FDA’s announcement of single pivotal trials for most drugs (https://www.raps.org/news-and-articles/news-articles/2026/).
Medical Devices
The US FDA issued the final guidance document Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions, which provides recommendations on design, labeling, and documentation to be included in premarket submissions for medical devices with cybersecurity risks. It supersedes the guidance document ‘Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions’ that was issued in June 2025.
The International Medical Device Regulators Forum (IMDRF) published 2 new documents to harmonize adverse event terminology (https://www.imdrf.org/documents/considerations-selection-imdrf-adverse-event-terminology-guide-industry-partners-and-healthcare-providers) and support regulatory reliance across regulatory agencies (https://www.imdrf.org/documents/playbook-medical-device-regulatory-reliance-programs).
Real-World Data
Recordings, slides, and transcript are available of an US FDA Town Hall held in February 2026, where the final guidance document Use of real-world evidence to support regulatory decision-making for medical devices (issued in December 2025) was discussed (https://www.fda.gov/medical-devices/medical-devices-news-and-events/town-hall-use-real-world-evidence-support-regulatory-decision-making-medical-devices-final-guidance).
CIOMS Glossary of ICH Terms & Definitions
The updated CIOMS Cumulative Glossary with a focus on Pharmacovigilance, Version 2.4 is now free for download on the CIOMS website. New additions include terms and definitions from the recent CIOMS Working Group XIV report on artificial intelligence in pharmacovigilance. Refer to https://cioms.ch/publications/product/cioms-cumulative-pharmacovigilance-glossary.
Good Lay Protocol Synopsis Practice
The Good Lay Summary Practice (GLSP) initiative in collaboration with other leading experts developed practical recommendations for crafting the Lay Protocol Synopsis (LPS). The public consultation of the draft Good Lay Protocol Synopsis Practice document is extended until the 7th of April, 2026 (https://glsp.network/good-lay-protocol-synopsis-practice).
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