The newsletter provides a summary of 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 draft ICH E6(R3) guideline, currently under public consultation, is the topic of many discussions. EMA has released the Meeting Report from the multi-stakeholder workshop on ICH E6(R3) – Public Consultation – Day one (https://www.ema.europa.eu/en/events/act-eu-pa04-multi-stakeholder-workshop-ich-e6-r3-public-consultation). The NIH Pragmatic Trials Collaboratory Grand Rounds webinar ‘Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6[R3])‘ with presentations and related discussions is available online (https://rethinkingclinicaltrials.org/news/grand-rounds-august-18-2023-opportunities-to-improve-clinical-trials-draft-revision-of-the-ich-good-clinical-practice-guideline-e6r3-prof-sir-martin-landray-fmedsci-m-khair-elzarrad-phd-mph/).
ACT EU WEBSITE
A dedicated website on the Accelerating Clinical Trials in the EU (ACT EU) initiative, run by the European Commission, EMA and Heads of Medicines Agencies (HMA), has been launched (https://accelerating-clinical-trials.europa.eu/index_en). This website contains key resources on clinical trials in the EU for patients, sponsors, and regulators and will provide updates on the implementation of the Clinical Trials Regulation (CTR) and the related Clinical Trials Information System (CTIS).
EMA NEWS
From 20 October 2023, EMA will publish Risk Management Plans (RMPs) for all centrally authorized products, with the aim to increase transparency of the safety review process. The publication of RMPs concerns the main body and Annexes 4 and 6 for initial evaluations and RMP updates. The RMP summaries will no longer be published from the same date. For more information, refer to https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pharmacovigilance/risk-management/risk-management-plans. A template for the declaration for the RMP publication (that it does not contain any personal protected data nor commercial confidential information) is also available on this webpage.
FDA DRUGS AND BIOLOGICS NEWS
The US FDA published the following final guidance document: ‘Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies’, which recommends approaches that sponsors can consider in these situations. The appendix to the guidance further explains those approaches by providing answers to questions that the FDA received about conducting clinical trials during major disruptions.
MASTER PROTOCOLS
The ISO has published a plain language standard to improve communication in different sectors. ISO 24495-1:2023 ‘Plain language – Part 1: Governing principles and guidelines’ features high-level principles, guidelines, and techniques to help writers everywhere produce communications that work (https://www.iso.org/standard/78907.html).
MEDICAL DEVICES
The US FDA published the following final guidance document: ‘Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions’, which provides recommendations regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. The guidance supersedes the 2014 final guidance ‘Content of Premarket Submissions for Management of Cybersecurity in Medical Devices’.
TRANSPARENCY & DISCLOSURE
TransCelerate published the final version of ‘Clinical data sharing: a proposed methodology to enable data privacy while improving secondary use’ dated August 2023 (https://www.transceleratebiopharmainc.com/wp-content/uploads/2023/08/FINAL-Privacy-Methodology-Revision-August-25.pdf). The proposed methodology provides privacy preserving techniques and approaches for relevant data variables with the goal to protect the privacy of research participants and improve data utility when using clinical trial data for secondary research. A transparency checklist can also be downloaded and used independently of the methodology.
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