Digest: August 2025 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
The revised guideline for good clinical practice (GCP) ICH E6(R3) principles and Annex 1 came into effect in the EU on 23 July 2025.
In follow-up to the publication of the ICH E20 draft Guideline “Adaptive Designs for Clinical Trials” in June 2025, the EWG has also prepared a Step 2 informational presentation (https://www.ich.org/page/efficacy-guidelines#19-1).
CTR & CTIS
Frequently asked questions (FAQ) related to clinical trials submitted under the EU CTR reaching the European Medicines Agency (EMA) through different channels were addressed by the Clinical Trials Coordination Group (CTCG) in collaboration with the European Medicines Agency Clinical Trials Systems and Clinical Trials Transformation workstreams. This living resource will provide clear and concise answers to common questions, supporting sponsors in the efficient conduct of clinical trials across Europe and is available at https://www.hma.eu/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/CTCG/2025_07_CTCG_FAQ_V1.0.pdf.
EMA News
EMA revised the Procedural advice on paediatric applications (Rev. 13), together with the templates for the scientific document for paediatric investigation plan or product-specific waiver and for the key elements form. The use of the new templates is mandatory by 08 September 2025 (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-medicines-applications-procedures).
EMA revised the Q&As on the External Guidance on the Implementation of Policy 0070 (Rev. 4), which addresses key questions related to the clinical data publication (CDP) process, anonymization (PPD)/Anonymization Report, and CCI, and provides a compilation of, and references to, relevant guidance, recommendations and supportive documentation to facilitate the submission of documents in the context of CDP (https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-qas-external-guidance-policy-0070-clinical-data-publication-cdp_en.pdf).
US FDA Drugs & Biologics News
The US Food & Drug Administration (FDA) published the following final guidance document: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products, providing recommendations on formal meetings related to the development and review of biosimilar or interchangeable biological products regulated by the CDER or CBER.
FDA’s CDER Center for Clinical Trial Innovation (C3TI) released a white paper encouraging to reduce the collection of certain types of data for drugs with a well-characterized safety profile, referred to as selective safety data collection (SSDC). The white paper describes the ICH E19 guidance on SSDC, discusses oncology and cardiometabolic trials that incorporated SSDC, and explores the potential future use of SSDC (https://www.fda.gov/about-fda/cder-center-clinical-trial-innovation-c3ti/selective-safety-data-collection-ssdc-demonstration-project).
Transparency & Disclosure
The PHUSE data transparency autumn event will take place 16–18 September 2025 from 16:00-18:30(CEST)/10:00-12:30(EDT). This is a virtual event and free to attend – but you must be registered. For more information, refer to https://advance.hub.phuse.global/wiki/spaces/WEL/pages/26804393/Working+Groups+Events.
Artificial Intelligence
The European Commission has published the General Purpose AI Code of Practice. The Code is designed to help industry comply with the AI Act’s rules on general-purpose AI, which will enter into application on 02 August 2025 (https://digital-strategy.ec.europa.eu/en/policies/contents-code-gpai).
Medical Devices
The EU Medical Device Coordination Group (MDCG) released guidance document MDCG 2025-7 MDCG Position Paper: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles.
A new expert panel has been established for pediatrics and rare disease devices. EMA now has 13 expert panels that offer scientific and technical expertise for evaluating medical devices under the Medical Device Regulations and the In Vitro Diagnostic Medical Device Regulations (https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/medical-device-expert-panels).
EUDAMED
The launch of the EUDAMED database is delayed again. The declaration in the EU Official Journal that the module(s) is/are functional is currently planned for Q3 2025 for the first modules. Each module will become mandatory to use 6 months after the declaration of its functionality is published in the EU Official Journal (https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en?filename=md_eudamed_roadmap_en.pdf).
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