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 draft ICH E6(R3) Annex 2 guideline reached Step 2a/b of the ICH process. Annex 2 provides GCP considerations in the context of clinical trials with various design elements and data sources (eg, trials that incorporate decentralized elements, pragmatic elements, and/or real-world data) to ensure they are fit for purpose. Annex 2 should be read in combination with the ICH E6(R3) Principles and Annex 1 document.
✍ CTR & CTIS
Annex I of the Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS), the accompanying Q&A document on the protection of Commercially Confidential Information (CCI) and Personal Data while using CTIS (version 2.2; updated Question 3.2 on dose details disclosure), and quick guide for users on revised CTIS transparency rules and historical trials (v1.8) have been updated (https://accelerating-clinical-trials.europa.eu/our-work/implementation-clinical-trials-regulation_en).
A review by the UK DIA Medical Writing Committee (Koo et al.) of early experience with clinical trial applications under the EU CTR was published in Therapeutic Innovation & Regulatory Science. This paper provides recommendations for preparing documents (eg, clinical study protocol, investigator’s brochure, plain language protocol synopsis) to ensure compliance with the EU CTR and for protecting CCI in documents submitted to CTIS (https://link.springer.com/article/10.1007/s43441-024-00726-2).
✍ EMA News
EMA hosted a webinar to present its plans on the proposed expansion of activities related to Policy 0070. Presentations and video recordings can be found here: https://www.ema.europa.eu/en/events/clinical-data-publication-policy-0070-webinar-step-2.
Heads of Medicines Agencies (HMA) and EMA released a revised HMA/EMA guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application (MAA) dossier to align it with day-to-day practice and to ensure all authorities continue to follow a harmonized approach. The Annex now includes examples of information that may be considered CCI or protected personal data (https://www.hma.eu/fileadmin/dateien/HMA_joint/00-_About_HMA/02-Transparency/2024-12-HMA-EMA-guidance-on-PD-and-CCI-in-the-MMA.pdf).
✍ FDA Drugs & Biologics News
The US FDA issued the following final guidance documents:
- Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development, which provides information to sponsors using circulating tumor DNA as a biomarker in cancer clinical trials.
- E11A Pediatric Population, which is the adoption of the ICH E11A guideline, providing recommendations and a harmonized framework for the use of pediatric extrapolation to support the development and authorization of pediatric medicines.
✍ ClinicalTrials.gov
National Library of Medicine (NLM) published the final report on the ClinicalTrials.gov modernization effort, including an update on the modernized ClinicalTrials.gov public website and Protocol Registration and Results System (PRS) websites, progress on modernization’s strategic goals, received stakeholder input, and future modernization activities (https://www.nlm.nih.gov/od/bor/NLM_BOR_CTG_WG_Modernization_Update_Report_20241031_508.pdf).
✍ Artificial Intelligence/Machine Learning
The Lancet published guidelines on the declaration of the use of AI in journal articles: “Generative AI: ensuring transparency and emphasizing human intelligence and accountability” (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02615-1/abstract).
✍ Medical Devices
The EU Medical Device Coordination Group (MDCG) released the following guidance documents:
- MDCG 2024-15 Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED, outlining expectations for sponsors until EUDAMED is fully operational.
- MDCG 2023-3 Rev.1 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (including new questions and updates to align with Regulation (EU) 2017/746 on IVDR).
The US FDA issued the final guidance document Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions, which recommends including a Predetermined Change Control Plan that describes the planned AI-enabled device software function modifications, associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications in a marketing submission.
✍ EUDAMED
The European Commission published a Q&A document on practical aspects related to implementing the gradual roll-out of EUDAMED pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 (https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf).
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