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 conducted a survey in 2024 that demonstrates a strong level of implementation and adherence to ICH guidelines by regulatory authorities (https://admin.ich.org/sites/default/files/2024-10/ICHImplementationPublicReport_Final_2024_1001.pdf).
ICH developed an Introductory Training Video about the ICH E8(R1) Guideline on General Considerations for Clinical Studies.
✍ Declaration of Helsinki
The revised Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants was updated and released on 21 October 2024. This new version replaces ‘subjects’ with ‘participants’ throughout.
✍ EMA News
An interim report is available on the European medicines regulatory network’s experience with analyzing patient-level clinical study data submitted voluntarily by marketing authorization applicants and holders. This report offers preliminary insights into the regulatory benefits of including clinical study data in the marketing authorization application dossier. It includes experience gained between September 2022 and December 2023 (https://www.ema.europa.eu/en/documents/report/proof-concept-pilot-using-data-clinical-studies-medicines-evaluation-interim-report_en.pdf).
✍ FDA Drugs & Biologics News
The US FDA issued the following final guidance documents:
- M13 Bioequivalence for Immediate-Release Solid Oral Dosage Forms, which is the adoption of the ICH M13 guideline. The guidance document is supplemented with a Q&A document.
- Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development, which provides a framework on whether and what type of long-term neurologic, sensory, and developmental evaluations could be useful.
- Core Patient-Reported Outcomes in Cancer Clinical Trials, providing recommendations to sponsors for collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design.
- Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers, providing information for all stakeholders on their use in clinical investigations of foods, medical products, tobacco products, and new animal drugs.
✍ FDA-NIH Terminology for Clinical Research
The US FDA and the National Institutes of Health (NIH) developed a draft glossary of clinical research terms related to innovative clinical trial design, including studies using real-world data to generate real-world evidence. The document helps bring clarity to terms that are inconsistently used within the scientific community (https://www.fda.gov/media/178477/download).
✍ Artificial Intelligence/Machine Learning
The US FDA has published a special communication entitled “Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine.” In this publication, the authors review the history of the US FDA regulation of AI; present potential uses of AI in medical product development, clinical research, and clinical care; and present concepts that merit consideration as the regulatory system adapts to AI’s unique challenges (https://jamanetwork.com/journals/jama/fullarticle/2825146).
✍ CIOMS Glossary of ICH Terms & Definitions
The updated CIOMS Glossary of ICH terms and definitions, Version 7, is now free for download on the CIOMS website. New additions include definitions from the ICH guidelines E11A, M13A, and Q4B(R1). Refer to https://cioms.ch/publications/product/glossary-of-ich-terms-and-definitions/#description.
✍ Medical Devices
The EU Medical Device Coordination Group (MDCG) released the following guidance documents:
- MDCG 2022-5 Rev.1 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices Healthcare products are normally regulated as medicinal product or as medical device but not both. Borderline products are those whose regulatory classifications are unclear. The guidance aims to provide clarity.
- MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices, clarifying which products fall within the scope of Regulation 2017/746 (IVDR) as in vitro diagnostic medical devices.
- MDCG 2021-25 rev.1 Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC (including updates to align with the general structure of MDCG guidance documents and with Regulation (EU) 2023/607).
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