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 ICH E6(R3) Guideline for good clinical practice (GCP) reached Step 4 of the ICH process. The revised guideline facilitates innovations in clinical trial design and conduct, an provides guidance to help ensure participant safety and reliability of clinical trial results. A presentation with an overview of new and revised information is available on the ICH website (https://www.ich.org/news/ich-e6r3-introductory-training-presentation-now-available-ich-website).
CTR & CTIS
The Clinical Trial Regulation (CTR) (EU) No 536/2014 Questions & Answers Version 7 has been published. Changes include updates to Annex II & Annex III (for further details, refer to https://health.ec.europa.eu/document/download/bd165522-8acf-433a-9ab1-d7dceae58112_en?filename=regulation5362014_qa_en.pdf).
Note: On 31 January 2025, the CTR became fully applicable. Activities related to the CTR are supported by the Accelerating Clinical Trials in the EU (ACT EU) initiative, which is run by the EMA, Heads of Medicines Agencies, and European Commission.
EMA News
EMA published the ICH E6(R3) guideline for good clinical practice (Step 5). It will come into effect on 23 July 2025 (https://www.ema.europa.eu/en/ich-e6-good-clinical-practice-scientific-guideline).
The ACT EU initiative published their third workplan, covering activities for 2025 and 2026, and the achievements from 2024 (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/accelerating-clinical-trials-eu-act-eu).
European Health Data Space (EHDS)
The Council of the EU adopted the European Health Data Space Regulation. The new EU law will make it possible to exchange and access health data across the EU and to make certain non-identifiable health data available for research and innovation. For more information, refer to https://data.consilium.europa.eu/doc/document/PE-76-2024-INIT/en/pdf.
FDA Drugs & Biologics News
US FDA officials have clarified how sponsors can achieve agency diversity action plan goals within multiregional clinical trials (MRCTs) in an article published in the New England Journal of Medicine (https://www.nejm.org/doi/full/10.1056/NEJMp2409392?query=health-policy).
Clinical Trials.gov
Modernised PRS now includes the ability to create results for interventional and observational studies. In addition, users can enter data in the newly added Baseline Characteristics module (https://register.clinicaltrials.gov/prs/beta/public/release-notes-prod).
Real-World Data
The new PHUSE Real World Data Spring Event will take place on 9-10 April 2025. For more information, visit the website available at https://advance.hub.phuse.global/wiki/spaces/WEL/pages/64290817/Real+World+Data+Spring+Event+2025.
Medical Devices
The EU Medical Device Coordination Group (MDCG) released the following guidance documents:
- MDCG 2024-2 Rev.1 Procedures for the updates of the European Medical Device Nomenclature (EMDN); MDCG 2021-12 Rev.1 FAQ on the EMDN; MDCG 2025-1 EMDN Ad hoc procedure form; MDCG 2025-2 EMDN update submissions from 2024 public consultation and the MDCG nomenclature working group; and MDCG 2025-3 EMDN Version History, which are guidance documents and forms related to the EMDN.
- MDCG 2023-3 Rev.2 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (including updates related to Eudamed).
ICMJE
The International Committee of Medical Journal Editors (ICMJE) published an editorial to raise awareness about predatory publishing practices (https://www.icmje.org/news-and-editorials/predatory-journals-editorial.pdf).
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