Digest: October 2026 Featured news that matters in medical writing and communications
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 has published the updated combined ICH E14/S7B Questions & Answers (R1), providing further clarification on the clinical and nonclinical evaluation of QT/QTc prolongation and proarrhythmic risk.
ICH made training materials available for ICH M11 to support stakeholders involved in clinical trial protocol development and review. There are 10 modules. Visit the ICH Training Library and scroll to the ‘Multidisciplinary’ section and then M11 to access the materials.
CTR and CTIS
Work is ongoing to prepare for the go-live of a new safety module for the submission and management of Annual Safety Reports (ASRs) in CTIS. Users will be informed of the date of the go-live in due course. After the go-live, a two-month transition period will follow.
EMA News
EMA has published an article entitled “Two trials or not two trials? That should not be the question” in Nature Reviews Drug Discovery (authors Arlett P, et al.); available at https://www.nature.com/articles/s41573-026-01537-w. The article was written in response to recent discussions, including the FDA draft guidance on pivotal clinical trials, and emphasizes that regulatory decisions should focus on the strength and relevance of the available evidence rather than a fixed number of trials.
EMA adopted and published ICH M13B Guideline on bioequivalence for immediate-release solid oral dosage forms – additional strengths biowaiver. It provides recommendations on obtaining waivers of bioequivalence (BE) studies for one or more additional strengths of a drug product in an application where in vivo BE has been demonstrated for at least one of the strengths; the guideline will come into effect on 17 March 2027.
Real-World Data
The HMA-EMA Real-World Data (RWD) Catalogues provide a centralized global repository of real-world data sources and studies. A new feature allows to upload a visual study summary upon study completion, helping users quickly understand key findings and enhancing the visibility, accessibility, and impact of research outcomes.
The PHUSE Working Group: Real World Evidence published Real-World Data Reliability and Integrity: Ensuring Real-World Data is Fit for Use for Regulatory Submissions. This white paper outlines key fitness-for-use requirements for RWD in regulatory settings. It provides an overview of applicable regulatory expectations, considerations for assessing data providers, and technical requirements for tools used to ensure that RWD is relevant, reliable, and suitable for regulatory decision-making.
US FDA Drugs & Biologics News
The US FDA issued a direct final rule replacing references to ‘animal tests’ and ‘animal studies’ with the broader terms ‘nonclinical tests’ and ‘nonclinical studies’ in FDA regulations, reflecting evolving approaches to drug development and safety assessment. The rule also introduces definitions for key nonclinical terms and harmonizes terminology across safety and reporting requirements. In parallel, the FDA has published a companion proposed rule that would make related amendments should the direct final rule be withdrawn following significant adverse comments. Comments must be submitted by 7 December 2026.
Data Transparency
The PHUSE Working Group: Data Transparency published the White Paper Protecting Commercially Confidential Information (CCI) While Complying with the European Union Clinical Trials Regulation 536/2014. The document outlines practical approaches for sponsors to identify and safeguard sensitive commercial information within clinical trial documentation submitted with Clinical Trial Applications (CTAs), while ensuring compliance with EU transparency and public disclosure requirements (see https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Data+Transparency/WP-119.pdf).
EU COMBINE
The EU COMBINE project was launched in June 2023 to address challenges encountered by sponsors when conducting combined studies that require application of Regulation (EU) 536/2014 (clinical trials on medicinal products for human use) together with Regulation (EU) 2017/745 (on medical devices) or 2017/746 (on in vitro diagnostic medical devices). As part of COMBINE Project 2, a Sponsors’ Guide on safety reporting in combined studies was published. Topics include definitions, investigator and sponsor responsibilities, reporting pathways, management of potential double reporting, urgent safety measures, and protocol content requirements.
MedDRA
The Medical Dictionary for Regulatory Activities (MedDRA) version 29.1 is available. This update only includes changes at the Preferred Term and Lowest Level Term levels. No new Standardised MedDRA Queries (SMQs) were introduced.
Medical Devices
The EU Medical Device Coordination Group (MDCG) released the following guidance document: MDCG 2020-16 Rev.5 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (including clarification of the rationale and revision of examples for Rule 7).
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