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 ICH Q1 draft guideline on Stability Testing of Drug Substances and Drug Products reached Step 2b of the ICH process and entered the public consultation period. The ICH Q1 draft guideline combines and modernizes the content of ICH Q1A-F and Q5C into 1 comprehensive stability guideline.
CTR & CTIS
The Clinical Trial Regulation (CTR) (EU) No 536/2014 Questions & Answers Version 7.1 has been published. Changes include updates to Annex II (https://health.ec.europa.eu/document/download/bd165522-8acf-433a-9ab1-d7dceae58112_en?filename=regulation5362014_qa_en.pdf).
The World Health Organization (WHO) designated CTIS as a primary registry, meaning it adheres to specific criteria for content, data quality and validity, accessibility, unique identification, technical capacity, and administration. WHO’s primary registries meet the ICMJE standards, which is a prerequisite for clinical trials to be published in general medical journal articles (https://www.ema.europa.eu/en/news/clinical-trials-information-system-designated-who-primary-registry).
EMA News
The EMA revised the Procedural advice on paediatric applications – Guidance for applicants (EMA/672643/2017 Rev.12), including a revision of section 5.2.3 on clarification dialogues before re-submission (during clock-stop), refer to https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedural-advice-paediatric-applications_en.pdf.
The EMA revised“Anonymisation of personal data and assessment of commercially confidential information during the preparation and redaction of risk management plans (body and Annexes 4 and 6).” This document provides guidance to applicants/marketing authorization holders on anonymization or deletion of personal data and commercially confidential information when drafting risk management plans (RMPs), and on redaction of approved RMPs (body + Annexes 4 and 6) for publication. It also includes EMA recommendations for the most frequent issues regarding the redacted RMP (https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-anonymisation-protected-personal-data-assessment-commercially-confidential-information-during-preparation-rmps-main-body-annexes-4-6_en.pdf).
CONSORT & SPIRIT
Updated CONSORT and SPIRIT (2025) statements for improving the completeness and transparency of protocols and reports of randomized trials have been published. The CONSORT checklist (for reporting randomized trials) was changed substantially, including 7 new items, 3 revised items, 1 deleted item, and several integrated items from key CONSORT extensions. The SPIRIT checklist (for protocols of randomized trials) includes 2 new items, 5 revised items, 5 deleted/merged items, and integrated items from other relevant reporting guidelines. The respective explanation and elaboration documents were also updated. For details, refer to https://www.consort-spirit.org/.
ICMJE Recommendations
The ICMJE updated the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals: removal of list of journals following ICMJE recommendations (Sections I.B and III.L.1), addition of link to ICMJE predatory journals editorial (Section II.C.1.a), timely responsiveness of journals to authors (Section II.C.2.b), diversity and inclusion in publishing images (Section II.C.2.e), update to 2024 Declaration of Helsinki (Section II.E), corrections of errors (Section III.A), scientific misconduct (Section III.B), reference citations (Section IV.A.3.g) (https://www.icmje.org/icmje-recommendations.pdf).
Real-World Data
EMA published a Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence for regulatory purposes. The scope of this paper is the design, conduct, and statistical analysis of non-interventional studies using RWD to generate RWE for regulatory purposes (https://www.ema.europa.eu/en/documents/other/reflection-paper-use-real-world-data-non-interventional-studies-generate-real-world-evidence-regulatory-purposes_en.pdf).
Medical Devices
The European Association of Medical Devices Notified Bodies (Team NB) released the following position papers:
· Version 2.0 of European Artificial Intelligence Act, providing their perspective on the implementation and application of the EU AI Act (https://www.team-nb.org/team-nb-position-paper-on-european-artificial-intelligence-regulation-v2/).
· Version 3.0 of Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of the MDR (EU) 2017/745, clarifying information to be submitted in the technical documentation. The most common reasons for delays in review by NB are incomplete submissions and lack of cohesive structure of technical documentation (https://www.team-nb.org/team-nb-position-paper-on-best-practice-guidance-for-the-submission-of-technical-documentation-under-annex-ii-and-iii-of-medical-device-regulation-eu-2017-745-v3/).
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