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!
✍ CTR & CTIS
The Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation Version 4 includes clarifications on consequences of non-compliance with transition measurements, on the interface with medical devices and in vitro diagnostics, and on active sites; minor amendments to elements related to the Clinical Trials Information System (CTIS) transparency rules; additional information on 2 member states in Annex I; and addition of Annex II (decision tree administrative transition clinical trial). The document can be found at https://health.ec.europa.eu/medicinal-products/clinical-trials_en.
The Clinical Trials Coordination Group (CTCG) updated Recommendations related to contraception and pregnancy testing in clinical trials, providing practical guidance on contraception use and pregnancy testing in clinical trials. It should be read in conjunction with published guidelines related to this topic (https://www.hma.eu/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/CTCG/2024_HMA_CTCG_Contraception_guidance_Version_1.2__March_2024.pdf).
The quick guide for sponsors CTR (EU) No 536/2014 in practiceVersion 5 updated Annex I in line with the latest version of Clinical Trials Coordination Group (CTCG) Best practice guide on naming of documents.
✍ EMA News
EMA resumed its policy for publication of clinical data included in marketing authorization applications (Policy 0070) in September 2023. A new anonymization report form template was developed jointly by EMA and the Health Canada Public Release of Clinical Information (PRCI) team, together with instructions on how to complete the form. It supersedes the anonymization report included in annex 1.2 of the guidance document (https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/clinical-data-publication/support-industry-clinical-data-publication).
✍ EU COMBINE
The EU COMBINE project was launched in June 2023 to address challenges encountered by sponsors when conducting combined studies that require application of Regulation (EU) 536/2014 together with Regulation (EU) 2017/745 or 2017/746. In the Analysis Phase Report, issues were collected, categorized and clustered, the EU landscape was mapped at a Member State level, documents (including guidance documents, Q&A documents, relevant standards) related to combined studies were mapped, and all results were analyzed and translated into a roadmap for future work (https://health.ec.europa.eu/document/download/77e1409a-f4c0-45db-bff1-4873c7a0e7ae_en?filename=md_combined-analysis-phase-report.pdf).
✍ FDA Drugs & Biologics News
Recordings are now available of a Joint US FDA – Health Canada ICH Public Meeting held in February 2024 which included presentations by FDA, Health Canada, PhRMA, and BIO experts on ICH guidelines reaching significant ICH milestones (https://www.fda.gov/drugs/news-events-human-drugs/joint-us-fda-health-canada-ich-public-meeting-02222024).
✍ Real-World Data
The Council for International Organizations of Medical Sciences (CIOMS) published a comprehensive report on Real-world data and real-world evidence in regulatory decision making. This consensus report describes the potential use of real-world evidence (RWE) for decision making, real-world data (RWD) and data sources, key scientific considerations in the generation of RWE, and ethical and governance issues in using RWD (https://cioms.ch/publications/product/real-world-data-and-real-world-evidence-in-regulatory-decision-making/#description).
TransCelerate’s white paper Assuring Audit and Inspection Readiness – Considerations for the Use of RWD and RWE in Regulatory Decision-Making provides greater clarity as to the type of information and documentation regulators may request about the sources and process by which RWD/RWE is compiled. More information can be found at https://www.transceleratebiopharmainc.com/assets/real-world-data-solutions/#audit-readiness.
✍ Clinical Research Glossary
The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), in collaboration with CDISC, developed a comprehensive and publicly available plain language glossary of clinical research terms and procedures. It introduces 160 terms, images, and resources for patient-facing materials (https://mrctcenter.org/glossary/).
✍ Medical Devices
The EMA Q&A on the implementation of the Regulations (EU) 2017/745 and 2017/746 in the context of combinations of medicinal products and medical devices has been updated (Rev. 4). Several questions were revised and new questions were added on advice on qualification/clarification of a drug-device combination (Q 1.3); the scope of the notified body opinion (Q 2.4); submission of changes to the device (Q 2.7) and the medicinal product (Q 2.8); labelling requirements for co-packaged medical devices (Q 3.2.1); and consultation procedure for companion diagnostic (Q 5.1) (https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf).
✍ PHUSE Data Transparency
The PHUSE data transparency autumn event will take place 17–19 September 2024 from 15:00-17:30(BST)/10:00-12:30(EDT). This is a virtual event and free to attend – but you must be registered. For more information, visit the website available at https://advance.phuse.global/display/WEL/Data+Transparency+Autumn+Event+2024.
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