MEDICAL WRITING NEWS
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 M11 updated version of the Technical Specification document, which incorporated comments from the first public consultation, reached Step 2b of the ICH process and entered the second round of public consultation. The updated Template is provided as a reference to assist in reviewing the Technical Specification and will not open for public comment.
CTR & CTIS
The EMA updated Module 18 of the CTIS Training Programme, FAQs – How to submit an annual safety report and respond to related RFIs (v1.2). Questions regarding the annual safety report, submission process, assessment phases, responses to RFIs, and annual safety report roles and permissions are answered (https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-faqs-how-create-and-submit-annual-safety-report-and-respond-related-requests-information-ctis-training-programme-module-18_en.pdf).
EMA News
The EMA and the HMA published Seizing opportunities in a changing medicines landscape – The European medicines agencies network strategy 2028, an update of the 2025 strategy. It will help to prepare the network for revisions to the pharmaceutical legislation and changes to the technological and regulatory landscape. The strategy also acts as a guide to address challenges and threats such as public health emergencies and antimicrobial resistance (https://www.ema.europa.eu/en/documents/other/seizing-opportunities-changing-medicines-landscape-european-medicines-agencies-network-strategy-2028-final_en.pdf).
The EMA and other European National health agencies published Clinical Evidence 2030, highlighting 6 guiding principles for clinical evidence generation: patients voice, existing knowledge/gaps, research question, evidence generation (real-world evidence and clinical trials), evidence-based decisions, and transparency (https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1002/cpt.3596).
European Health Data Space (EHDS)
The Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 was published (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025R0327). The Regulation is an important milestone in the EU’s efforts to build a secure and efficient digital health ecosystem as part of the European data strategy. The fact sheet can be found at https://ec.europa.eu/commission/presscorner/api/files/attachment/878490/Factsheet%20European%20Health%20Data%20Space_EN.pdf.
FDA Drugs & Biologics News
The US FDA revised a paper about how its different centers (CBER, CDER, CDRH, and OCP) collaborate to protect public health while fostering responsible and ethical medical product innovation through artificial intelligence (https://www.fda.gov/media/177030/download).
Artificial Intelligence/Machine Learning
The WHO released a policy document Health data governance in the age of artificial intelligence: policy imperatives for the WHO European Region, aiming to provide evidence-informed recommendations for developing and strengthening national health data governance frameworks to facilitate the safe and effective uptake of AI into health systems (https://www.who.int/europe/publications/i/item/WHO-EURO-2025-11462-51234-78079).
Real-World Data
The European Federation of Pharmaceutical Industries and Associations (EFPIA) published a paper on Harnessing RWE to Transform Healthcare Decision-Making in Europe, including EFPIA’s future vision on role and use of RWE in healthcare decision-making, opportunities and challenges of RWE, and key actions to unlock RWE (https://www.efpia.eu/news-events/the-efpia-view/efpia-news/harnessing-rwe-to-transform-healthcare-decision-making-in-europe/).
The Council for International Organizations of Medical Sciences (CIOMS) published a paper summarizing the comprehensive report on Real-world data and real-world evidence in regulatory decision making that describes the use of RWE for decision making in the product lifecycle, RWD and data sources, key scientific considerations in the generation of RWE, and ethical and governance issues in using RWD (https://onlinelibrary.wiley.com/doi/10.1002/pds.70117?af=R).
Medical Devices
The EFPIA published a reflection paper on The challenges of integrating medical devices (MDs) into medicinal product clinical trials – CTA documentation, including a proposal for a harmonized interpretation of the EU CTR and MDR (https://www.efpia.eu/media/q3dbt3hf/challenges-of-integrating-mds-into-medicinal-product-clinical-trials.pdf).
The EU Medical Device Coordination Group (MDCG) released guidance document MDCG 2020-16 Rev.4 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (changes include a modified rationale, revised examples, and modified footnote).
The US FDA issued the final guidance document Evaluation of Sex-Specific Data in Medical Device Clinical Studies, which outlines expectations regarding sex-specific patient enrollment, data analysis, and study information reporting.
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