Announcements & Notifications
Regulatory 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 […]
» read moreNew Chief Regulatory Officer, Post Marketing Control Division
May 17th, 2021In a simple ceremony on 14th May 2021 , Mr. Kunzang Dorji was instated as the Chief Regulatory Officer, Post Marketing Control Division, Drug Regulatory Authority. He served as the Deputy Chief Regulatory Officer, Inspection Division (DRA) prior to taking the current position. Tashi Delek!
» read moreDRA Competency Examination
May 10th, 2021This is to inform that DRA will be conducting Competency Examination on 28th May, 2021. Those having the qualifications as per BMRR 2019 and wishing to appear the exam are requested to reach the Registration Division, DRA by 9:30 am with the following documents: CID Copy BMHC certificate Two recent size passport Photo Fee: Nu […]
» read moreSelection Result of Chief Regulatory Officer
April 29th, 2021The Drug Regulatory Authority (DRA) is pleased to announce the result of the open competitive selection interview held on 15 April 2021 for the post of Chief Regulatory Officer, Post Marketing Control Division as follows: Kunzang Dorji, holding EID no. 200901173, Dy. Chief Regulatory Officer of Inspection Division, DRA is selected as Chief Regulatory Officer […]
» read moreRegulatory Notification on Regulation of Medical Masks
April 19th, 2021Regulation of medical masks (surgical mask and surgical respirator) for containing the spread of airborne diseases.In exercise of power conferred by section 5 of The Medicines Act of the Kingdom of Bhutan 2003 and as per the recommendation from the Ministry of Health and National Covid-19 Task Force, the Drug Regulatory Authority (DRA) is pleased […]
» read moreSummary of COVID-19 vaccines with Emergency Use Authorization (EUA) in Bhutan
March 19th, 2021Please click on the link below to view the summary: Summary of COVID-19 vaccines with Emergency Use Authorization (EUA) in Bhutan
» read moreDraft Guideline for Advertisement of Medical Products for comments
March 3rd, 2021We are pleased to share the draft Guideline for Advertisement of Medical Products for comments and suggestions from relevant stakeholders. You may send your comments or views on the draft document latest by 31st March, 2021 to pmcd@dra.gov.bt. Please click here to view the Draft Guideline for Advertisement of Medical Products
» read moreVacancy Announcement-Reschedule
February 3rd, 2021With reference to the postponement of the date of application submission No. DRA/D4b/16-PRO(Adv)2021/444 dated December 30, 2020, the Drug Regulatory Authority is pleased to reschedule the last date for submission of application for the post of Chief Regulatory Officer, Post Marketing Control Division to 9th February 2021. However, those who have already submitted the application […]
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