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
A webinar was held by the ICH M11 Expert Working Group to describe the latest developments on the ICH M11 Guideline, Protocol Template, and Technical Specifications. The benefits and opportunities created by the M11 Protocol Template, the development of the Protocol Template, and the purpose of the Technical Specifications in supporting the exchange and storage of clinical trial data were explained. The recording and slides are available at https://ctti-clinicaltrials.org/new-ich-m11-harmonised-guideline-protocol-template-and-technical-specification/.
✍ CIOMS Glossary
An updated version of the CIOMS Glossary of ICH Terms and Definitions was published. The glossary combines the terms and definitions used in the ICH guidelines. This version 2.0 (17 January 2023) is available at https://cioms.ch/publications/product/glossary-of-ich-terms-and-definitions/).
✍ EMA News
The European Commission, the Heads of Medicines Agencies, and the EMA published recommendations to facilitate the conduct of decentralized clinical trials (ie, outside the traditional ‘clinical trial site’), while safeguarding the rights and well-being of participants as well as the robustness and reliability of the collected data. It covers trial oversight (roles and responsibilities), informed consent process, IMP delivery, trial related procedures at home, data management, and trial monitoring. For more information, refer to https://health.ec.europa.eu/system/files/2022-12/mp_decentralised-elements_clinical-trials_rec_en.pdf.
The EMA will be working on the restart of clinical data publication via Policy 0070. No specific date for the restart has been communicated at this point. The EMA has been publishing clinical data for COVID-19 medicines in line with its exceptional transparency measures for treatments and vaccines for COVID-19.
✍ EU CTR 536/2014 Q&A Update
The Clinical Trial Regulation (EU) No 536/2014 Questions & Answers Version 6.3 has been published. Changes and updates compared to the superseded version are outlined in the document history on the front page and importantly include the creation of a new Annex III detailing websites where sponsors can find national requirements to submit high quality Part II documents as part of their clinical trial applications (see https://health.ec.europa.eu/system/files/2022-12/regulation5362014_qa_en.pdf).
✍ FDA Drugs & Biologics News
The US FDA recently released the following final guidance document:
· ‘Format and Content of a REMS Document’, which provides recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product, including a biological drug product. It contains an overview of the types of information that should be included. The current format organizes the REMS requirements by who is responsible for implementing the requirement, when the requirement is to be implemented, what action is required, and with what REMS material(s). This format also makes greater use of tables and bulleted lists.
· It is supplemented with the ‘REMS Document Technical Conformance Guide’, which provides detailed instructions on the format of a REMS document, and standardized language that describes common REMS requirements to help ensure consistency and facilitate efficient review of the REMS document. The appendices contain a detailed REMS Document template and Bifurcated REMS Document outline, respectively. This guide will be updated periodically.
✍ EU MDR & IVDR Update
The European Commission adopted a proposal for amending the EU MDR and EU IVDR as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. The overall goal is to ensure continued access for patients while ensuring the transition to the new framework. Key elements of the proposal are as follows:
· Staggered and conditional extension of the transition period until 2027/2028, according to risk class of the device
· Extended validity of certificates
· Cancellation of “sell-off” date (ie, allowing devices placed on the market before or during the transition period to continue to be made available without time limitation)
For details, refer to https://health.ec.europa.eu/system/files/2023-01/mdr_proposal.pdf).
✍ Medical Devices
The Notified Body BSI is organizing the Series 2 Clinical Masterclass on Medical Devices starting 11 January 2023. The 5-part series will focus on 5 key clinical documents: the Clinical Evaluation Plan; Clinical Evaluation Report; Post Market Clinical Follow Up Plan; Post Market Clinical Follow Up Report; and the Summary of Safety and Clinical Performance.
- The webinar information can be found at https://www.bsigroup.com/en-GB/medical-devices/resources/webinars/2023/mdr/clinical-masterclass/?utm_source=Social+Media&utm_medium=LinkedIn&utm_content=Clinical-Master-Class-2023-all-webinars&utm_campaign=MD-LinkedIn-2211.