Digest: January 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

On 16 December 2025, the Australian regulator, the Therapeutic Goods Administration (TGA), adopted ICH E6(R3) Guideline for Good Clinical Practice: Principles and Annex 1 (effective date: 13 January 2026). There will be a 12-month transition period to allow stakeholders time to meet the updated requirements (https://www.tga.gov.au/resources/resources/international-scientific-guidelines-adopted-australia/ich-e6r3-guideline-good-clinical-practice).

 

CTR & CTIS

The ACT EU Trial Map has been enhanced with improved search capabilities in national EU/EEA languages, making it faster and easier for healthcare professionals and patients to access information (https://ec.europa.eu/newsroom/ema/newsletter-archives/70161).

 

EMA News

EMA published a Guidance for Stepwise PIPs (sPIPs). In exceptional cases, crucial information to define key elements of the planned measure is not yet available at the time of initial Pediatric Investigation Plan (PIP) application. The stepwise PIP (sPIP) consists of only a partial development program, containing a minimum set of data (including condition, preliminary outline of planned studies based on available evidence, and PIP completion date), conditional on the development of a full PIP once the crucial information has become available. Refer to https://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/guidance-stepwise-pips-en.pdf.

 

EMA adopted and published ICH M11 Guideline on Clinical Electronic Structured Harmonized Protocol (CeSHarP), M11 CeSHarP Template, and M11 CeSHarP Technical Specification.

 

US FDA Drugs & Biologics News

The US FDA issued the following final guidance documents:

• Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices, which provides guidance to clinical investigators to comply with safety reporting requirements for investigational new drug (IND) application studies and investigational device exemption (IDE) studies.
• Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies, which provides guidance to sponsor and sponsor-investigators to comply with safety reporting for IND and bioavailability/bioequivalence studies.
• Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs, which recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of a representative population in their clinical trials.

 

Medical Devices

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

• MDCG 2025-9 Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746, which provides guidance for manufacturers, expert panels and notified bodies, facilitating a streamlined pathway for CE marking and market access of breakthrough devices.
• MDCG 2025-10 Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices, which provides guidance on the post-market surveillance (PMS) system and PMS plan.
• MDCG 2025-7 rev.1 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 (including addition of references to EU regulations and MDCG guidance documents, and updated timelines).

 

The European Commission adopted a proposal to reduce and simplify the rules on medical and in vitro diagnostic devices. The key elements of the revision are summarised in a factsheet and in a questions and answers document (https://health.ec.europa.eu/medical-devices-sector/new-regulations_en).

 

CIOMS Glossary of ICH Terms & Definitions

The updated CIOMS Glossary of ICH terms and definitions, Version 9, is now free for download on the CIOMS website. New additions include definitions from the ICH guidelines E20, E22, E2B(R3), E2D(R1), M11, M14, and Q3E. Refer to https://cioms.ch/publications/product/glossary-of-ich-terms-and-definitions/#description.

 

Real-World Data

The US FDA issued an updated version of Use of real-world evidence to support regulatory decision-making for medical devices. This guidance clarifies the evaluation of quality of real-world data for generating real-world evidence that can be used in regulatory decision-making for medical devices (refer to https://www.fda.gov/media/190201/download). The strength of submitted real-world evidence will be considered on an application-by-application basis, without requiring identifiable individual patient data (https://www.fda.gov/news-events/press-announcements/fda-eliminates-major-barrier-using-real-world-evidence-drug-and-device-application-reviews).

 

THANK YOU FOR READING!

Stay tuned for more medical writing news!