Featured news that matters in medical writing and communications

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 M13A Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms, which provides recommendations on conducting bioequivalence studies for orally administered immediate-release solid oral dosage forms, and the supporting Q&As reached Step 4 on 23 July 2024.

CTR & CTIS

The Clinical Trial Regulation (EU) No 536/2014 Questions & Answers Version 6.9 includes revised points 108 and 256, and new point 255 (to align with the revised CTIS transparency rules); updates to Q3.13 (about change of the principal investigator) and Q6.1 (including reference to pediatric clinical trials results); new Q6.6 (on intermediate data analysis); and changes to Annexes II (footnote), III (email addresses and websites), IV (extension of validity decision), and V (deletion of SmPC requirement for authorized AxMPs). 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 ‘Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation’ (Version 4).

The Clinical Trials Coordination Group (CTCG) released the following documents (refer to https://www.hma.eu/about-hma/working-groups/clinical-trials-coordination-group.html):

• Safety addendum to clarify topics in addition to Section 7 of Q&A in EudraLex Vol10 in relation to CTIS (annual safety report, safety-relevant notifications, reference safety information, and requests for information sent within the adhoc workflow).
• New templates to facilitate validation and assessment of applications: cover letter for initial application (or resubmission) of new clinical trials; cover letter and description for substantial modification application; and RFI Response list of changes to the application.

EMA News

EMA updated From Laboratory to Patient: The Journey of a Centrally Authorized Medicine, a user-friendly manual that explains to the public what steps are taken in initial research stages of a new medicine, and how EMA provides scientific advice to support the timely development of safe and effective medicines.

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FDA Drugs & Biologics News

The US FDA issued the following final guidance documents:

• Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies, which provides recommendations on timing, study design, and reporting results of human radiolabeled mass balance studies.
• Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products, which assists sponsors in selecting data sources to maximize the completeness and accuracy of the data derived from electronic health records and medical claims for clinical studies.
• Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma, which provides recommendations for the licensure of COVID-19 convalescent plasma, or the study of investigational COVID-19 convalescent plasma under an IND.

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Medical Devices

The International Medical Device Regulators Forum (IMDRF) published Edition 4 of the key guidance on the table of contents of technical documentation (ie, the marketing authorization dossier) for IVD medical devices (https://www.imdrf.org/documents/vitro-diagnostic-medical-device-regulatory-submission-table-contents-ivd-toc) and for non-IVD medical devices (https://www.imdrf.org/documents/non-vitro-diagnostic-device-regulatory-submission-table-contents-nivd-toc).

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The EU Medical Device Coordination Group (MDCG) released the following guidance documents:

• MDCG 2020-16 Rev.3 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (including a new definition, revised examples, and revision of rules on self-testing devices and specimen receptacles)
• MDCG 2021-5 Rev.1 Guidance on Standardization for Medical Devices (including explanations on the “state of the art” and clarifications, removal of references to old directives, and addition or updates of references).

?The US FDA published the final guidance document Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder, which provides recommendations for the design of pivotal clinical studies for devices intended to treat opioid use disorder.

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WHO MeDevIS

The WHO has introduced an online platform called MeDevIS (Medical Devices Information System), the first global open access clearing house for information on medical devices. It is designed to support governments, regulators and users in their decision-making on selection, procurement and use of medical devices for diagnostics, testing and treatment of diseases and health conditions. The WHO announcement is https://www.who.int/news/item/08-07-2024-medevis-platform-announced-to-boost-access-to-medical-technologies-and-devices.

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THANK YOU FOR READING!

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