Public Consultation on the Guideline on regulatory preparedness for the oversight of emergency use authorized medical products

The Medical product division of the Bhutan Food and Drug Authroity is pleased to present the draft guideline for the regulatory oversight of emergency use authorized medical products for your comments.

This guidance document aims to outline a comprehensive strategy for regulatory
preparedness, detailing the processes for the oversight of Emergency Use Authorised
(EUA) medical products. It underscores the importance of a proactive and coordinated
approach involving key stakeholders, including regulatory authorities, healthcare
providers, manufacturers, and public health agencies. By establishing clear criteria for
EUA, defining submission requirements, and outlining post-authorization monitoring and
communication strategies, this document seeks to provide a structured pathway to ensure
that EUA products are rigorously evaluated and appropriately managed throughout their
lifecycle.

Please kindly send your comments and recommendations by 21st of March, 2025 to schoden@bfda.gov.bt

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