Announcements & Notifications
Regulatory Notification: Amendment of Interim guidelines for regulating face masks (medical grade) to facilitate availability of medical grade face mask in Bhutan
December 2nd, 2021Please click here to view the notification
» read moreRegulatory Notification: Sample exemption acceptance of dossiers in soft copy for the purpose of registration during pandemic
November 30th, 2021Please click here to view the notification
» read moreRegulatory Notification on Bioequivalence and Biowaiver Requirements for Generic Drugs
November 23rd, 2021Please Click her to view the Notification
» read moreCompetency Examination
November 4th, 2021This is to inform that DRA will be conducting Competency Examination on November 19, 2021. Individuals with qualifications as per BMRR 2019 and wishing to sit for the exam are requested to report to the Registration Division, DRA by 9:30 am with the following documents: CID Copy BMHC certificate Two recent size passport Photo Fee: […]
» read moreRegulatory Notification on Sale and Distribution of Health Supplement Products
October 8th, 2021Please click here to view the notification
» read moreRegulatory Notification on Import of Health Supplements for Personal Use
September 9th, 2021Click here to view the notification
» read moreRegulatory Notification on Revised/New Guidelines
July 12th, 2021Click here to view the notification
» read moreRegulatory Notification on Requirement of Import Authorization for medical syringes
June 28th, 2021Drug Regulatory Authority (DRA) hereby notifies all potential importers (Market Authorization Holders) that Import Authorization from DRA is required for importation of any medical syringes.Following documents shall be furnished at the time of Import Application: i. Manufacturer and packaging details (in the absence of products samples);ii. Description of the intended use(s) of the syringe. If […]
» read moreDRA Foundation Day, 14 June 2021
June 14th, 2021The Drug Regulatory Authority was established in 2004 to enforce the Medicines Act of the Kingdom of Bhutan 2003. The first Bhutan Medicines Board meeting was held on 14 June, 2004. Since its establishment, the regulation of medicinal products in Bhutan has progressed with expansion of roles and functions such as regulation of Blood and […]
» read more40th Drugs Technical Advisory Committee Meeting, 2 June 2021
June 3rd, 2021The 40th Drugs Technical Advisory Committee Meeting was convened on 2nd June at Rochogpel in Thimphu. The committee deliberated on a wide array of issues ranging from emergency use authorization of Covid-19 vaccines to interchangeability of Covid-19 vaccines and post EUA changes. In addition, five DRA Technical Guidelines were endorsed for implementation. The DTAC advises […]
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