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 outlines the current standards required for medicines to be approved for use in the Bhutanese market, ensuring their safety, efficacy, and quality. Additionally, the document provides a comprehensive overview of the procedures involved in the Market Authorization process.
We kindly invite you to provide any comments, suggestions, or recommendations to help enhance this guideline. Please send your feedback to schophel@bfda.gov.bt by April 30, 2025.
Thank you for your valuable input.