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 the timely accessibility of quality-assured pharmaceuticals and vaccines in the country.
Please kindly send your comments and recommendations by 30th of June, 2025 to schoden@bfda.gov.bt.