The Medical Products Division of the Bhutan Food and Drug Authority (BFDA) is pleased to present the draft Guideline for Authorization and Establishment of Manufacturing Facility for Medicinal Products for your review and feedback.
This guidance document is intended to provide guidance on the establishment of manufacturing facilities for medicinal products in the country aligning with international best practices. It also offers direction to both the regulatory authority and applicants to ensure compliance with technical and regulatory requirements.
We kindly request that you submit your comments, suggestions or recommendations to help enhance the guideline. Please send your feedback to schophel@bfda.gov.bt by 31, August 2025.
Thank you for your valuable input and cooperation.