Digest: December 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

 

Module 1 (Introduction and Foundational Concepts) of the Interpretation and Application of ICH E6(R3): Good Clinical Practice Guideline for ICH E6(R3) training material is available on the ICH website (https://www.ich.org/page/training-library). Four other modules on Responsibilities and Oversight, Data Governance, Informed Consent, and Essential Records will be published later.

 

The ICH M14 Guideline “General Principles on Planning, Designing, Analysing, and Reporting of Non-interventional Studies That Utilise Real-World Data for Safety Assessment of Medicines” will come into effect (in Europe) on 18 March 2026.

 

CTR & CTIS

 

The EU Clinical Trial Map (launched in March 2025) is now accessible in all official EU languages. Patients and healthcare professionals can access information about clinical trials in their own language (https://euclinicaltrials.eu/search-for-clinical-trials/trial-map/?lang=en).

 

EMA News

 

On 23 September 2025, the European Commission (EC), the Heads of Medicines Agencies (HMA), and EMA jointly developed two new targets for clinical trials, to monitor progress to make the European Union (EU) a more attractive destination for clinical research and improve timely access to innovative medicines for patients (https://www.ema.europa.eu/en/news/new-targets-clinical-trials-europe).

 

US FDA Drugs & Biologics News

 

The US FDA issued the following final guidance documents:

• Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments, which provides guidance that is generally applicable to clinical outcome assessments (such as patient-reported outcome), and is intended to help sponsors use high quality measures of patients’ health in medical product development programs.
• Expanded Access to Investigational Drugs for Treatment Use Questions and Answers (Rev. 1), which provides information on expanded access to investigational drugs for treatment use under an investigational new drug application, in a question-and-answer format.

 

For the final guidance document Conducting Clinical Trials with Decentralized Elements, a guidance snapshot was created for sponsors, investigators and other interested parties (https://www.fda.gov/media/189263/download?attachment).

 

Transcelerate CPT

 

Transcelerate is revising the CPT to align with ICH M11 Protocol Template. To help sponsors with implementation planning, Transcelerate released a “preview draft” of the CPT Basic Word edition and supporting materials. Transcelerate expects to release the final version of the CPT in early 2026. Links to the Transcelerate preview draft together with supporting overview and reference materials are available here: https://www.transceleratebiopharmainc.com/assets/clinical-content-reuse-solutions/.

 

Medical Devices

 

MedTech Europe published the 4th edition of the clinical evidence e-book titled ‘Clinical Evidence Requirements under the EU In Vitro Diagnostics Regulation (IVDR)’. Changes affect the following chapters: Chapter 7 Companion Diagnostics; Chapter 14  Next Generation Sequencing; Chapter 15 Real-World Evidence (https://www.medtecheurope.org/wp-content/uploads/2020/05/clinical-evidence-requirements-ebook_fourth-edition.pdf).

 

Artificial Intelligence/Machine Learning

 

The European Commission has published the official FAQs on the AI Act. The list of FAQs has been compiled based on queries received during the AI Pact webinars as well as submissions from stakeholders. This list will be updated regularly and as needed (https://ai-act-service-desk.ec.europa.eu/en/faq).

 

World Health Organization (WHO)

 

On 07 October 25, WHO launched the Global Clinical Trials Forum (GCTF), a global, multi-stakeholder network to strengthen clinical trial environments and infrastructure at national, regional, and global levels (https://www.who.int/initiatives/global-clinical-trials-forum).

 

THANK YOU FOR READING!

Stay tuned for more medical writing news!