Digest: June 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 final overview presentation to support the M11 Guideline on Clinical electronic Structured Harmonised Protocol (CeSHarP). The guideline consists of 3 interconnected documents that together standardise clinical trial protocol format, content, and exchange: a harmonised guideline; a clinical trial protocol template; and a technical specification to enable the electronic exchange of protocol contents. These 3 documents apply to interventional clinical trials of medicinal products across all phases and therapeutic areas, covering pharmaceuticals, biologics, vaccines, drug-device combinations, and cell or gene therapy products. Refer to https://www.ich.org/page/multidisciplinary-guidelines#11-1.
The US FDA adopted the ICH M11 guideline, with the notice of availability published in the Federal Register on 22 May 2026 (see below).
WHO
WHO launched a free online course ‘WHO Good Practices for Clinical Trial Design and Implementation’. The course translates the WHO Guidance for Best Practices for Clinical Trials into practical, applied learning, and is freely available on their online learning platform (https://whoacademy.org/coursewares).
CTR & CTIS
The Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) and its Annex I (version 2.2) and the quick guide (v2) have been updated. The former separate Q&A document has been replaced with a link to the CTIS Sponsor Frequently Asked Questions (FAQs) (https://accelerating-clinical-trials.europa.eu/our-work/implementation-clinical-trials-regulation_en).
The European Commission, EMA, and HMA published their first quarterly report about clinical trial applications submitted to CTIS in Q1 2026 and cumulatively since the launch of CTIS on 31 January 2022, and the progress towards the 2030 clinical trial targets. The full report is available at https://accelerating-clinical-trials.europa.eu/index_en.
EMA News
The EMA published a revised Explanatory Note to Good Pharmacovigilance Practices (GVP) Module VII (Rev 4), which all marketing authorization holders should consult when preparing Periodic Safety Update Reports (PSURs). It addresses issues and requests for clarification raised during the PSUR single assessment period (PSUSA). The accompanying Questions & Answers on PSUSA: Guidance document for assessors was also revised (Rev 1). Refer to https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/periodic-safety-update-reports-psurs.
The following EMA templates have been updated:
- Response to list of questions/list of outstanding issues: Quality / Non-clinical / Clinical.
- Request for compliance check on an agreed paediatric investigation plan (PIP) (v2).
US FDA Drugs & Biologics News
The US FDA issued the following final guidance documents:
- Postapproval Pregnancy Safety Studies, which provides recommended methods to assess the safety of drugs and biological products when used during pregnancy in the postapproval setting.
- Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application, which provides recommendations to applicants planning to submit bioequivalence information in ANDAs.
- Statistical Approaches to Establishing Bioequivalence, which provides recommendations to sponsors and applicants planning to use equivalence criteria in analyzing bioequivalence studies for INDs, NDAs, and ANDAs.
- Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations, which provides recommendations to sponsors planning to conduct food-effect studies for orally administered drug products as part of INDs and NDAs.
- Pulmonary Tuberculosis: Developing Drugs for Treatment, which assists sponsors in the clinical development of new antibacterial drugs for the treatment of pulmonary tuberculosis.
- Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention, which assists sponsors in the clinical development of drugs to support an indication of treatment, reduction of recurrence, or prevention of Clostridioides difficile infection.
- M11 Clinical Electronic Structured Harmonised Protocol, which is the adoption of the ICH M11 guideline.
MRCT (P4 Toolkit)
The MRCT center released the first 3 tools in the Pregnancy Privacy Protections for Participants Toolkit, which inform about data privacy risks if a participant becomes pregnant during a study. The first 2 are directed toward clinical teams and IRBs, while the third is for research staff to adapt and share with participants (https://mrctcenter.org/resource/pregnancy-privacy-protections-for-participants-p4-toolkit/).
Medical Devices
The European Commission published an Implementing Regulation (EU) 2026/977, outlining uniform quality management and procedural requirements for conformity assessment activities carried out by notified bodies under the MDR and IVDR. The implementing regulation will take effect on 25 February 2027, except for the annual report on timelines and costs of conformity assessment activities which will take effect on 01 January 2028.
The US FDA issued the following final guidance documents:
- Content of Human Factors Information in Medical Device Marketing Submissions, which provides a risk-based framework to guide manufacturers and FDA staff on the human factors information to be documented and included in marketing submissions.
- Patient-Matched Guides for Orthopedic Implants, which provides recommendations on information to be included in regulatory submissions for patient-matched guides for orthopedic implants.
EUDAMED
The first 4 modules (Actors, UDI/Devices, Notified Bodies and Certificates, and Market Surveillance) were declared functional on 27 November 2025. Therefore, their use is mandatory from 28 May 2026.