Digest: May 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 developed a training module to support the M15 Guideline on General Principles for Model-informed Drug Development. The M15 Guideline reached Step 4 on 29 January 2026.

CTR & CTIS

The updated version of the CTCG Frequently asked questions (FAQ) related to Clinical trials submitted under the Regulation EU 536/2014 expands the initial document into a comprehensive guidance covering the full clinical trial lifecycle. New sections were added: clinical trial application fields and documents; labelling of investigational and auxiliary medicinal products; trial conduct and assessment; and end of trials and submission of results (https://www.hma.eu/fileadmin/dateien/CTCG_FAQ_v2_final_clean.pdf).

EMA News

The EMA revised the Procedural advice on paediatric applications (Rev. 15), 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 these new templates is mandatory as of 16 April 2026 (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-medicines-applications-procedures).

The EMA has released Clinical Data Publication. Questions and Answers (Q&As) on the European Medicines Agency policy on the publication of clinical data for medicinal products for human use (Policy 0070) work-share initiative with Health Canada (HC). The work-share process is a voluntary collaborative review shared between EMA and HC for procedures that are common to both agencies. The Q&As provide guidance to applicants regarding the work-share process, eligibility criteria for work-share, and applicants’ responsibilities (https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/clinical-data-publication/support-industry-clinical-data-publication).

US FDA News

The US FDA issued the following final guidance documents:

Bioanalytical Method Validation for Biomarkers, which provides recommendations to sponsors on validating bioanalytical methods used to evaluate biomarker concentrations. This guidance can also inform the development of bioanalytical methods used for the analysis of biomarker concentrations in nonclinical study samples.
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers (Rev. 2), which provides information on expanded access to investigational drugs for treatment use under an investigational new drug application, in a question-and-answer format.

The US FDA announced the successful initiation of 2 proof-of-concept real-time clinical trials (RTCT) and seeks to build on these proofs-of-concept with a broader pilot program for RTCT (https://www.fda.gov/news-events/press-announcements/fda-announces-major-steps-implement-real-time-clinical-trials?utm_medium=email&utm_source=govdelivery).

PHUSE (Participant Data Return)

PHUSE have released the results of their “Participant Data Return Survey”. The survey asked PHUSE member companies to share their practices and perspectives on returning data to clinical trial participants. A blog post summarising the results and next steps can be accessed at https://phuse.global/Communications/PHUSE_Blog/participant-data-return-survey-results.

Real-World Data

The US FDA has published a new set of 73 examples of marketing authorisations using real-world evidence from financial years 2020-2025. The new examples highlight the growing use of real-world data to validate device software functions, including artificial intelligence and machine learning-enabled technologies (https://www.fda.gov/news-events/fda-voices/real-world-evidence-advancing-regulatory-decision-making-medical-devices).

Medical Devices

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

MDCG 2026-1 Summary of EMDN 2025 Submissions and outcome of annual revision; MDCG 2026-2 2025-2026 Annual Revision Change Log; MDCG 2026-3 2026 EMDN Version History; MDCG 2021-12 rev.2 FAQ on the EMDN; Guidance on the Version History, which are guidance documents related to the European Medical Device Nomenclature (EMDN).
Q&A rev.2 Q&A Obligation to inform in case of interruption or discontinuation of supply, including addition of a link to the Article 10a Decision tree diagram.
MDCG 2021-24 rev.1 Guidance on classification of medical devices, including further clarification and concrete examples for various product categories.

The MDCG subgroup (Borderline and Classification Working Group) released an updated manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (version 5) (https://health.ec.europa.eu/document/download/71a87df8-5ca1-4555-b453-b65bdf8de909_en?filename=md_borderline_manual_en.pdf).

EUDAMED

EUDAMED, the IT system established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices, is composed of 6 modules. Starting from 28 May 2026, the use of the first 4 modules is mandatory: Actor registration, UDI/Devices registration, Notified bodies and certificates, and Market Surveillance.

Artificial Intelligence & Privacy

The Belgian Data Protection Authority has published a brochure titled “The Impact of Artificial Intelligence (AI) on Privacy”, the first publication in its “AI & Data Protection” initiative. This information brochure has been prepared to help individuals understand how AI systems may affect their privacy and how to stay in control of their personal data. The publication can be accessed here: https://www.dataprotectionauthority.be/professional/news/2026/04/13/ai-data-protection-series—the-impact-of-artificial-intelligence-on-privacy.

THANK YOU FOR READING!

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