Digest: February 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 made training materials available for ICH E6(R3) Module 4 Informed Consent. There are 2 parts in this module. Module 4.1 focusses on who is involved in the informed consent process and the key elements of the informed consent materials and the informed consent discussion. Module 4.2 gives the key considerations of an informed consent process and also provides some practical considerations for obtaining and documenting informed consent. Visit the ICH Training Library and scroll to the ‘E’ section and then E6(R3) to access the materials.
CTR & CTIS
Clinical Trials Highlights newsletter included a reminder for sponsors:
- to ensure information in CTIS, especially the start of recruitment date, is accurate and up to date.
- to submit clinical trial results, including a layperson summary, in CTIS within 1 year of the end of the trial for adult clinical trials and within 6 months for pediatric trials (legal obligation under Article 37(4) of the Clinical Trials Regulation).
More information is available at https://euclinicaltrials.eu/ctis-for-sponsors/.
EMA News
The US FDA and EMA have jointly identified principles for good artificial intelligence (AI) practice in drug development. A common set of 10 guiding principles will inform, enhance, and promote the use of AI for generating evidence across all phases of the drug product life cycle (https://www.ema.europa.eu/en/documents/other/guiding-principles-good-ai-practice-drug-development_en.pdf).
EMA has allowed optional submission of new Marketing Authorisation Applications (MAAs) for Centrally Authorised Products using eCTD v4.0, while eCTD v3.2.2 remains accepted during the transition. Applicants must contact EMA before submitting in v4.0 and ensure compliance with EU technical requirements; this update introduces improved metadata, lifecycle management, and global interoperability. For the new EU eCTD v4.0, an additional practical guidance has been published.
US FDA Drugs & Biologics News
The US FDA has issued a list of guidance topics that the Center for Biologics Evaluation and Research (CBER) is considering for development during 2026. The list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CBER has already issued Level 1 draft guidances that may be finalized following review of public comments. The list is available at https://www.fda.gov/media/120341/download.
Medical Devices
The US FDA issued the following final guidance documents:
- Clinical Decision Support Software, which updates prior guidance, and clarifies how the agency interprets the statutory criteria that determine whether CDS software is regulated as a medical device under the Federal Food, Drug, and Cosmetic Act. The document provides numerous examples to illustrate the distinction between non-device CDS and device software functions.
- General Wellness: Policy for Low Risk Devices, which provides clarity regarding the agency’s interpretation of the compliance policy for low risk products that promote a healthy lifestyle (general wellness products).
World Health Organization (WHO)
The US has officially withdrawn from the World Health Organization (WHO). The WHO statement on notification of withdrawal of the United States can be read here: https://www.who.int/news/item/24-01-2026-who-statement-on-notification-of-withdrawal-of-the-united-states.
THANK YOU FOR READING!
Stay tuned for more medical writing news!