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 E21 draft guideline on “Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials” and ICHM4Q(R2) draft guideline on “The Common Technical Document (CTD) for the Registration of Pharmaceuticals for Human Use: Quality” reached Step 2 of the ICH process and entered the public consultation period. The ICH E21draft guideline provides recommendations for appropriate inclusion of pregnant and breastfeeding individuals in clinical trials. The ICH M4Q(R2) draft guideline outlines an updated structure and content of Quality sections in CTD Modules 2 and 3.
EMA News
EMA updated the External guidance on the implementation of the European Medicines Agency Policy 0070on the publication of clinical data for medicinal products for human use (EMA/90915/2016 v 1.5). This document provides guidance to industry on procedural aspects of submission and anonymization of clinical reports, and identification and redaction of commercially confidential information in clinical reports. An overview of updated, amended, or deleted information is available in the summary of changes document (https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/clinical-data-publication/support-industry-clinical-data-publication/external-guidance-implementation-european-medicines-agency-policy-publication-clinical-data-medicinal-products-human-use).
US FDA News
FDA completed their first AI-assisted scientific review pilot and announced an aggressive agency-wide AI rollout timeline. According to the press release, the generative AI tools enable FDA scientists and subject-matter experts to minimize time spent on monotonous, repetitive tasks that typically slow down the review process(https://www.fda.gov/news-events/press-announcements/fda-announces-completion-first-ai-assisted-scientific-review-pilot-and-aggressive-agency-wide-ai).
Artificial Intelligence/Machine Learning
The joint HMA/EMA Network Data Steering Group (NDSG) published the workplan 2025-2028 on Data and AI in medicines regulation (v1.2), to optimize the use of data and artificial intelligence(https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/network-data-steering-group-ndsg).
WHO
WHO published a paper Reporting summary results in clinical trial registries: updated guidance from WHO. The paper describes the current registry policies landscape, and the rationale and new WHO guidance for reporting summary results in clinical trial registries(https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(24)00514-X/fulltext).
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