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.
CTIS
EMA is working on the technical implementation of the revised CTIS transparency rules, foreseen for Q2 2024. In the meantime, for initial clinical trials applications sponsors may follow the principles of the revised CTIS transparency rules. A sponsor may refrain from deferring publication of documents and provide a version ‘for publication’ and ‘not for publication’ only for those documents in scope of the revised rules (as detailed in Annex I of the revised CTIS transparency rules). Refer to https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-12-january-2024_en.pdf.
FDA Drugs & Biologics News
The US Food & Drug Administration (FDA) published the following final guidance documents:
- Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, which provides recommendations regarding chemistry, manufacturing, and control, pharmacology and toxicology, and clinical study design. The guidance focuses on CAR T cell products, but some of the information and recommendations provided are also applicable to other genetically modified lymphocyte products (eg, CAR natural killer cells).
- ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs, which provides recommendations on the timing and content of amendments to tentatively approved abbreviated new drug applications (ANDAs). This guidance supersedes the guidance issued in September 2020.
Clinical Trials Gov
The modernized ClinicalTrials.gov website includes a new section ‘Submit Studies’, where users can find information on how to register a clinical study and how to submit results. In addition, Policy Information can also be found in a new section ‘Policy’, which also includes the FAQs and Date Element Definitions.
The Good Cause Extension (GCE) Request Process and Criteria document has been updated to include additional situations that would be considered “not good cause” for granting an extension request to extend the deadline for submitting clinical trial results information to ClinicalTrials.gov. A new FAQ was also added.
EMA News
EMA has added the section “Resumption of clinical data publication for all medicines” on the clinical data publication website. After a period of suspension, EMA has resumed clinical data publication for medicines with new active substances that received a CHMP opinion from September 2023 onwards. The clinical data packages for non-COVID-19 medicines published following the resumption are available in January 2024 via EMA’s clinical data website (https://clinicaldata.ema.europa.eu/web/cdp/home).
EMA has released a major revision of its user guide for micro, small, and medium-sized enterprises in the pharmaceutical sector. It contains comprehensive information on the EU legislative framework for medicines. The guide focuses primarily on the requirements for authorizing medicinal products for human or veterinary use. It also includes a section on activities related to medical devices (https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/user-guide-micro-small-and-medium-sized-enterprises_en.pdf).
Artificial IntelligenceI
The European Commission has launched a package of measures to support European startups and micro, small, and medium-sized enterprises in developing trustworthy artificial intelligence (AI) that respects EU values and rules. The package includes a proposal to provide privileged access to supercomputers to AI startups and the broader innovation community. Further information can be found at https://ec.europa.eu/commission/presscorner/detail/en/ip_24_383.
Medical Devices
The European Commission is proposing more time for companies to apply the In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. The Commission is also proposing measures to enhance transparency in the medical device sector (including speeding up the launch of some elements of the European Database on Medical Devices – EUDAMED). Read the full press release here: https://ec.europa.eu/commission/presscorner/detail/en/IP_24_346.
The European Commission and Member States have created Medical Device Regulation (MDR) and IVDR tables to help companies understand the language requirements for the information and instructions that accompany a device in a specific country. The tables provide an overview of the language requirements for each Member State (https://health.ec.europa.eu/publications/overview-language-requirements-manufacturers-medical-devices_en).
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