Digest: July 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
The ICH E6(R3) Annex 2 guideline reached Step 4 of the ICH process. Annex 2 provides additional GCP considerations, focusing on trials that incorporate decentralised elements, pragmatic elements and/or real-world data (RWD). Annex 2 should be read in combination with the ICH E6(R3) Principles and Annex 1 document.
CIOMS Glossary of ICH Terms & Definitions
The updated CIOMS Glossary of ICH terms and definitions, Version 10, is now free for download on the CIOMS website. New additions include definitions from the ICH guidelines E6(R3) Annex 2, M15, and Q14. Refer to https://cioms.ch/publications/product/glossary-of-ich-terms-and-definitions/#description.
SPIRIT-ROUTINE
The SPIRIT-ROUTINE extension provides a practical minimum reporting standard for protocols using, or considering using, cohorts or other routinely collected data (BMJ 2026;393:e087095). When paired with SPIRIT 2025, the extension enhances transparency around data sources and governance, clarifies planned analysis and validation methods, improves reviewers’ and regulators’ ability to evaluate bias risk, and facilitates quicker replication of key trials through openly shared code sets and algorithms. The guidance was developed in consultation with the CONSORT-ROUTINE study team. While the CONSORT-ROUTINE is a guideline for reporting trial itself, the SPIRIT-ROUTINE will serve as a guideline for reporting trial protocol.
CTR & CTIS
A revised application document template covering recruitment and informed consent procedures has been developed. Each section of the template allows for specifying additional information related to the Member State concerned. This revised version (v2.0) can be applied right away for all new Part II submissions, with a transition period in place until 01 September 2026 (https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-10_en#set-of-documents-that-are-applicable-to-clinical-trials-authorised-under-the-clinical-trials-regulation–eu-no-5362014).
EMA News
The EMA published a fourth report on their experience in conducting studies with real-world data (RWD) in the period from February 2025 until February 2026. The report is available at https://www.ema.europa.eu/en/documents/report/real-world-evidence-framework-support-eu-regulatory-decision-making-4th-report-experience-gained-regulator-led-studies-february-2025-february-2026_en.pdf. The DARWIN EU® network grew to 40 data partners (covering over 250 million patients from 18 European countries and adding close to 230 million patients from 3 US data centers). A total of 88 studies were completed or ongoing: 73 DARWIN EU® studies and 15 framework contract (FWC) studies.
US FDA Drugs & Biologics News
The US FDA issued the following final guidance documents:
- Certain Postapproval Requirements and Resources for ANDAs, which highlights postapproval statutory and regulatory requirements to holders of abbreviated new drug applications (ANDAs) and identifies related guidances and other resources.
- M15 General Principles for Model-Informed Drug Development, which is the adoption of the ICH M15 guideline.
Clinical Trials Gov
The National Library of Medicine has completed the modernization effort for the Protocol Registration and Results System (PRS) and the public website, ClinicalTrials.gov. The Modernized PRS is now the primary system for protocol registration and results submission. The timeline for phasing out the Classic PRS has been established (https://www.nlm.nih.gov/pubs/techbull/mj26/mj26_ctg_prs.html).
Medical Devices
Implementing Decision (EU) 2026/1231 and Implementing Decision (EU) 2026/1313 update the harmonized standards for the Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.
The EU Medical Device Coordination Group (MDCG) released the following guidance documents:
- MDCG 2026-4 MDCG Position Paper Management of SS(C)P in EUDAMED after Mandatory Use, which clarifies the shift in responsibility related to the uploading of the Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP) in EUDAMED.
- MDCG 2021-5 rev.1 – Appendix Transition to the “EU REP” symbol in EN ISO 15223-1, which describes the transition from the ‘EC REP’ symbol to the ‘EU REP’ symbol for authorized representatives, removing any reference to the term ‘European Community’.
PHUSE Data Transparency
The PHUSE Data Transparency Autumn Event will take place 15–17 September 2026 from 10:00-12:30 (EDT) / 15:0017:30 (BST) / 16:00-18:30 (CEST) agenda includes: Day One – Regulatory Compliance & Protecting Sensitive Information; Day Two – Global Transparency & Evolving Data Use Regulations; and Day Three – Innovation, Patient-Centred Transparency & Operational Excellence.
Artificial Intelligence
The EMA and Heads of Medicines Agencies (HMA) published the ‘2025 AI Observatory Report’. It provides an overview of emerging trends and helps the European Medicines Regulatory Network (EMRN) to anticipate future needs so that the network can lead on the use of AI in medicines regulation. Refer to https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/artificial-intelligence.
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