MEDICAL WRITING NEWS
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
The ACT EU workshop on ICH E6(R3) on 19-20 February 2025 focused on the principles and Annex 1 of the ICH E6(R3) guideline. Recordings and presentations are available at https://www.ema.europa.eu/en/events/act-eu-workshop-ich-e6-r3-principles-annex-1.
TransCelerate and ACRO co-developed frameworks, templates, and tools designed to support implementation of the new data governance section in the ICH E6(R3) guideline. This ICH E6 Asset Library can be found here: https://www.transceleratebiopharmainc.com/assets/ich-e6-asset-library/#DataGovernance.
CTR & CTIS
As of 31 January 2025, the Clinical Trials Regulation (EU) 536/2014 (CTR) became fully applicable with the Clinical Trials Information System (CTIS) supporting submission, assessment and oversight of all trials in the EU (https://www.ema.europa.eu/en/news/clinical-trials-regulation-becomes-fully-applicable).
The Clinical Trials Coordination Group (CTCG) published a Best Practice Guide for sponsors who have missed the transition timeline. Sponsors of ongoing Clinical Trial Directive (CTD) 2001/20/EC clinical trials without CTR approval must submit a complete new clinical trial application for approval in CTIS according to CTR rules (https://www.hma.eu/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/CTCG/2025-CTCG-_End-of-transition-note-for-Sponsors-V.1.pdf).
EudraCT
The EudraCT & EU Clinical Trials Register Frequently Asked Questions document has been revised (version 2.5). The use of the EudraCT database is now limited to the tasks described in question 2 (https://eudract.ema.europa.eu/docs/guidance/EudraCT%20FAQ_for%20publication.pdf).
EMA News
Updated guidance for applicants requesting advice on clinical trial and marketing authorization applications is available on the ACT EU website (https://accelerating-clinical-trials.europa.eu/our-work/consolidated-advice-clinical-trials_en). Developers of medicinal products can request joint scientific advice on their applications for clinical trials and the evidence needed for marketing authorization applications, provided by the CTCG and EMA’s Scientific Advice Working Party (SAWP). Applicants can also ask CTCG for technical and regulatory advice on a clinical trial application before submitting it to CTIS.
The ACT EU Clinical Trials Analytics Workshop developed a patient-friendly map of clinical trials in the EU. Viewers can search for a specific condition or location, and select trials based on recruitment status (https://euclinicaltrials.eu/search-for-clinical-trials/trial-map/?lang=en). The first version of the map is provided in English. Additional EU languages will be added in future releases.
FDA Drugs & Biologics News
The US FDA has published an information sheet entitled: “Institutional Review Boards Frequently Asked Questions.” The sheet is a compilation of answers to questions asked of FDA regarding the protection of human subjects of research. The questions and answers are grouped into sections; note that Section VI deals with the informed consent document content (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions).
Artificial Intelligence/Machine Learning
From 2 February 2025, the first rules of the Artificial Intelligence Act (AI Act), Regulation (EU) 2024/1689 laying down harmonized rules on AI, became applicable. These include the AI system definition, AI literacy, and a very limited number of prohibited AI use cases that pose unacceptable risks. The Commission published guidelines on the AI system definition and on prohibited AI practices. The guidelines and announcement can be found at https://digital-strategy.ec.europa.eu/en/library/commission-publishes-guidelines-ai-system-definition-facilitate-first-ai-acts-rules-application.
Medical Devices
The European Commission and Member States have launched a pilot coordinated assessment for clinical investigations (CI) and performance studies (PS) under Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). The pilot aims to create a harmonized, predictable process across Member States, reducing administrative burden for sponsors and ensuring high transparency and consistency in coordinated assessments (https://health.ec.europa.eu/medical-devices-clinical-investigations-and-performance-studies/pilot-coordinated-assessment-cips_en).
EMA has published an updated Q&A document on implementation of the MDR and IVDR. The update primarily includes additions with respect to the MAH’s compliance with the general safety and performance requirements (GSPRs) of the regulations as part of the Marketing Authorization Application (https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices#medical-device-legislation-13035).
EMA, in collaboration with the European Commission, has established a standard procedure for scientific advice on certain high-risk medical devices. Manufacturers can request advice on their intended clinical development strategy and proposals for clinical investigation (https://www.ema.europa.eu/en/news/ema-establishes-regular-procedure-scientific-advice-certain-high-risk-medical-devices).
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