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 obtaining Market Authorization. It outlines the current standards and practices required for medicines to be approved for use in the Bhutanese market, incorporating Good Reliance Practices to expedite the authorization process. The guideline also offers comprehensive details on the procedures that must be followed throughout the Market Authorization process.
We kindly invite you to share any comments, suggestions, or recommendations to improve this guideline. Please submit your feedback to schophel@bfda.gov.bt by April 30, 2025.
Thank you for your cooperation and valuable input.