MEDICAL WRITING NEWS
The newsletter provides a summary of the recent news or key updates in the field of medical writingand 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 Clinical Trial Regulation (EU) No 536/2014 Questions & Answers Version 6.8 includes updates to Q 1.17 (about auxiliary medicinal products – in line with the main guidance document); Q 1.19 (about Good Laboratory Practice – in line with the main guidance document); Q 2.15 (about the quality Investigational Medicinal Product Dossier); and minor updates to Annex III (email addresses and new website). Refer to https://health.ec.europa.eu/document/download/bd165522-8acf-433a-9ab1-d7dceae58112_en?filename=regulation5362014_qa_en_0.pdf. This Q&A document should be read in combination with the updated ‘Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation’ (Version 3).
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
The Accelerating Clinical Trials in the EU (ACT EU) initiative (run by the EMA, Heads of Medicines Agencies, and European Commission) has established a multi-stakeholder platform that allows to exchange views and discuss topics such as clinical trial design, conduct, statistical analysis, proposals for regulation optimization, data transparency, and patient engagement (https://www.ema.europa.eu/en/news/accelerating-stakeholder-collaboration-enhance-clinical-trials-environment-eu).
✍ European Health Data Space (EHDS)
The European Parliament and the Council of the EU reached political agreement on European Health Data Space. The new EU law will make it possible to exchange and access health data across the EU and to make certain non-identifiable health data available for research and innovation. For more information, refer to https://ec.europa.eu/commission/presscorner/detail/en/ip_24_1346.
✍ FDA Drugs & Biologics News
The US Food & Drug Administration (FDA) published the following final guidance documents:
- Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis, and Impact on Dosing, which assists sponsors in the design and analysis of studies that assess the influence of renal impairment on the pharmacokinetics of an investigational drug.
- Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry, which provides instructions for electronic submission of expedited individual case safety reports from IND-exempt bioavailability (BA)/bioequivalence (BE) studies in support of abbreviated new drug applications.
- Providing Regulatory Submissions in Electronic Format: IND Safety Reports, which describes the requirements for electronic submission of IND safety reports for serious and unexpected suspected adverse events.
✍ Real-World Data
Since the set-up of the Data Analysis and Real World Interrogation Network (DARWIN EU®), 14 real-world data (RWD) studies have been completed and 11 are ongoing. To further scale up the output of studies, DARWIN EU is looking for new data partners. Their aim is to deliver over 70 RWD studies in 2024 and over 140 RWD studies per year from 2025 onwards, to enhance more data-driven decision making on medicines in the EU.
✍ 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/).
✍ Artificial Intelligence
FDA issued 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/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device).
The EU Parliament approved the Artificial Intelligence (AI) Actthat ensures safety and compliance with fundamental rights, while boosting innovation. The regulation describes obligations for high-risk AI systems (which include AI systems used in healthcare).
✍ Medical Devices
The EU Medical Device Coordination Group (MDCG) released the MDCG 2024-3 Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices, which provides more details to sponsors about what type of information is expected in the CIP sections. A word template for a CIP synopsis is added as an appendix.
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