Digest: July 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 ICH E20 draft guideline on “Adaptive Design for Clinical Trials” reached Step 2b of the ICH process and entered the public consultation period. It describes the advantages and challenges of adaptive trial designs, the key principles for planning, conduct, analysis, and interpretation of adaptive trials; the different types of adaptations; and the documentation to be submitted before conduct and after completion of the trial.

 

EMA News

 

EMA published a training presentation SmPC guideline and paediatric aspects, including an overview of pediatric information to be included in the SmPC (https://www.ema.europa.eu/en/documents/presentation/presentation-summary-product-characteristics-guideline-paediatric-aspects_en.ppt).

EMA published an overview of comments received on ICH E6(R3) Guideline for good clinical practice – Annex 2 (https://www.ema.europa.eu/en/documents/comments/overview-comments-received-ich-e6r3-guideline-good-clinical-practice-annex-2-step-2b_en.pdf). ICH E6(R3) Principles and Annex 1 will come into effect on 23 July 2025; Annex 2 will be adopted at a later date.

 

US FDA News

 

The US Food & Drug Administration (FDA) published the following final guidance document:

 

• Conducting Remote Regulatory Assessments – Questions and Answers, including information about fully remote examinations of FDA-regulated establishments and/or its records to evaluate compliance with FDA requirements.

 

The US FDA and National Institutes of Health (NIH) published a joint glossary of clinical research terms related to innovative clinical trial design, including RWD/RWE terms, to increase effective scientific communication and transparency in clinical research (https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2835400).

 

Real-World Data

 

EMA published a third report on their experience in conducting studies with real-world data (RWD) in the period from February 2024 until February 2025, corresponding to Year 3 of DARWIN EU®. The report is available at https://www.ema.europa.eu/en/documents/report/real-world-evidence-framework-support-eu-regulatory-decision-making-3rd-report-experience-gained-regulator-led-studies-february-2024-february-2025_en.pdf.

 

The DARWIN EU® network expanded from 20 to 30 data partners (giving access to data from around 180 million patients from 16 European countries) and is now the main pathway for the generation of real-world evidence (RWE). A total of 59 studies were completed or ongoing: 46 DARWIN EU® studies, 8 framework contract (FWC) studies, and 5 in-house (EMA) studies.

 

Source: Infosheet – Review of real-world data studies (https://www.ema.europa.eu/en/documents/other/infosheet-ema-review-real-world-data-studies-september-2021-february-2025_en.pdf)

 

Medical Devices

 

The EU Medical Device Coordination Group (MDCG) released the following guidance documents:

 

• MDCG 2025-4 Guidance on the safe making available of medical device software (MDSW) apps on online platforms, which describes the obligations and responsibilities of app platform providers offering MDSW apps, to comply with the MDR/IVDR and Digital Services Act (DSA).
• MDCG 2025-5 Questions & Answers regarding performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746, which provides guidance for sponsors of performance studies of IVDs.
• MDCG 2025-6 FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA), which provides information for manufacturers related to the joint application of the AIA and MDR or IVDR. The document will be continuously developed and updated.
• MDCG 2019-11 rev.1 Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (including clarification of scope, addition of new examples, and updates related to the European Health Data Space Regulation).

 

The US FDA published the final guidance document Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, which provides recommendations on design, labeling, and documentation to be included in premarket submissions for medical devices with cybersecurity risks.

 

THANK YOU FOR READING!

 

Stay tuned for more medical writing news!