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!
✍ 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
ICH M12 Guideline on Drug Interaction Studies, which provides recommendations to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies, and the supporting Q&As reached Step 4 on 21 May 2024.
✍ CTR & CTIS
EMA’s revised transparency rules for the publication of information on clinical trials submitted through Clinical Trials Information System (CTIS) apply as of 18 June 2024. Refer to https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system/development-clinical-trials-information-system#ctis-transparency-rules-32694 for more information.
EMA updated Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS). This version 2 is aligned with the revised CTIS transparency rules, includes new sections on the ‘historical trials’ (ie, those submitted before 18 June 2024) publication principles and on transition trials, and removes Section 5 on Good Clinical Practice (GCP) inspection reports which is no longer applicable. Principles of protection of personal data and commercially confidential information remain unchanged compared to the previous versions. The guidance document should be read in conjunction with Annex 1 and the Q&A document (https://accelerating-clinical-trials.europa.eu/our-work/implementation-clinical-trials-regulation_en).
✍ EMA News
The Accelerating Clinical Trials in the EU (ACT EU) initiative (run by the EMA, Heads of Medicines Agencies [HMA], and European Commission) has launched 2 new advice pilots to improve clinical trials in Europe. The Scientific Advice Working Party (SAWP) – Clinical Trials Coordination Group (CTCG) pilot offers advice on scientific aspects of clinical trials towards clarification of both clinical trial and marketing authorization application requirements. The pre-clinical trial application pilot provides consolidated technical and regulatory support on the clinical trial application dossier prior to its submission through CTIS (https://www.ema.europa.eu/en/news/two-new-advice-pilots-improve-clinical-trials-europe).
✍ ClinicalTrials.gov
The classic ClinicalTrials.gov website was retired on 25 June 2024 and replaced by the modernized ClinicalTrials.gov website. To educate users on the modernized website, NLM created demonstration videos (https://www.nlm.nih.gov/oet/ed/ct/demo_videos.html?utm_medium=email&utm_source=govdelivery) and hosted a public webinar (https://www.nlm.nih.gov/oet/ed/ct/2024/modernization-updates.html?utm_medium=email&utm_source=govdelivery).
✍ FDA Drugs & Biologics News
The US FDA issued the following final guidance documents:
- Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics, which provides recommendations for certain evaluations during development, including characterizing the potential for QTc interval prolongation, performing immunogenicity risk assessment, characterizing the impact of hepatic and renal impairment, and assessing the potential for drug-drug interactions.
- Diabetic Foot Infections: Developing Drugs for Treatment, to assist sponsors in the clinical development of drugs for the treatment of diabetic foot infections (DFI) without concomitant bone and joint involvement.
✍Medical Devices
The EU Medical Device Coordination Group (MDCG) released guidance document MDCG 2024-10 Clinical evaluation of orphan medical devices, which provides more details to sponsors and notified bodies about the clinical evaluation and investigation requirements for orphan medical devices. Where relevant, this guidance should be read in conjunction with other MDCG guidance, including MDCG 2020-5, MDCG 2020-6, and MDCG 2023-7.
✍ Declaration of Helsinki
In 2022, a workgroup was established to revise the Declaration of Helsinki. A phase 2 comment period is open from 3 to 24 June 2024. The workgroup intends to recommend a final updated draft of the Declaration of Helsinki to the Medical Ethics Committee of the World Medical Association, and the document is intended to be considered by the Council and the General Assembly in Helsinki, Finland in October 2024 (https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/).
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