The Medical product division of the Bhutan Food and Drug Authority is pleased to present the draft guideline for collaborative registration procedure for pharmaceutical and vaccines for your comments. This guidance document aims to introduce a reliance registration pathway by relying on MA assessments conducted by reference authorities and institutions like the WHO and promote […]
This is to inform that we will be conducting Competency Examination on 06 May, 2025 from 09:30 am at the Ministry of Health. Individuals with qualifications as per BMRR 2019 and wishing to sit for the exam are requested to submit their applications using G2C services. Please use the link below to apply on the
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The Medical Products Division of the Bhutan Food and Drug Authority (BFDA) is pleased to present the draft Guideline for Combination Product for your review and feedback.This guidance document is designed to provide technical assistance to medical product suppliers regarding the regulatory requirement for registration of Combination Products (Device+Drug or Drug+Device).We kindly request that you
Public Consultation on Guidelines for Registration of Combination Products Read More »
The Medical Products Division of the Bhutan Food and Drug Authority (BFDA) is pleased to present the draft Guideline for Post-Approval Variation of Market Authorization of Medicinal Products for your review and feedback. This guidance document is designed to provide technical assistance to pharmaceutical product suppliers regarding the application procedures for Post-Approval Variation (PAV) submissions.
The Medical Products Division of the Bhutan Food and Drug Authority (BFDA) is pleased to present the draft Guideline for Market Authorization of Medicinal Products via the Abridged Route for your review and feedback. This guidance document is intended to provide technical assistance to medicine suppliers in the preparation and submission of application dossiers for
The Medical Products Division of the Bhutan Food and Drug Authority (BFDA) is pleased to present the draft Guideline for Market Authorization of Medicinal Products via the Standard Route for your review and feedback. This guidance document is designed to assist suppliers in the preparation and submission of application dossiers for obtaining Market Authorization. It
This is to inform that we will be conducting Competency Examination on 14 March, 2025 from 09:30 am at the Ministry of Health. Individuals with qualifications as per BMRR 2019 and wishing to sit for the exam are requested to submit their applications using G2C services. Please use the link below to apply on the
Competency Examination on 14 March, 2025 Read More »
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 regulatorypreparedness, detailing the processes for the oversight of Emergency Use Authorised(EUA) medical products. It