Announcements & Notifications
Guideline for Importation of Medicinal Products and Health Supplements
July 8th, 2022As per the provisions of the Medicines Act of the Kingdom of Bhutan 2003, applicants for importation of the medicinal product shall apply to the Authority in the prescribed form before importing the medicinal products into the country. Medicinal products include human and veterinary allopathic medicines, traditional medicines, vaccines, medical devices and blood & blood […]
» read moreDraft Guideline for Clinical Trials Authorization in Bhutan 2022
June 28th, 2022We are pleased to share the draft “Guideline for Clinical Trials Authorization in Bhutan 2022” for comments and suggestions from relevant stakeholders. You may send your comments or views on the draft document latest by 28th Sept. 2022 to gtshering@dra.gov.bt. Please click here to view the guideline
» 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 moreContact Details of Focal Person for Identified Regulatory Services During the Lockdown
January 9th, 2021With the announcement of nationwide, the Drug Regulatory Authority (DRA) hereby notifies the general public that DRA office will remain closed and the work from home mechanism will be reinstituted till further directives from the government. For matters that are urgent and require immediate action, please contact the following focal person(s). Sl.No Identified RegulatoryServices Focal […]
» read moreToll Free Numbers – National, Central, Southern and Eastern Regions of Bhutan
August 20th, 2020Please visit http://www.gov.bt/covid19/ for more details
» read moreGeneral Notice on Identified Regulatory Services and its Focal Person
August 15th, 2020With the announcement of nationwide lockdown on 11 August 2020, the Drug Regulatory Authority (DRA) hereby notifies the general public that DRA office will remain closed and the work from home mechanism willbe reinstituted till further directives from the government. To facilitate availability of medicines in the country, DRA will however facilitate import of medicines […]
» read moreTravel Advisory
January 30th, 2020In light of the coronavirus outbreak in Wuhan City, China and cases reported in 15 countries as of today(30th January 2020) including Sri Lanka, Singapore, Vietnam, Thailand and Nepal; the Ministry of Health urges the general public to avoid/postpone travel to these countries for holidays, pilgrimage, leisure etc… until the outbreak is officially contained/ TRAVEL […]
» read moreWelcome to #MedSafetyWeek! Join 57 medicines regulators around the globe in raising awareness of side effects and the risks of #polypharmacy.
November 25th, 2019The week of 25-29 November 2019 will mark the fourth annual #MedSafetyWeek, where medicine regulatory authorities across the world will take part in a social media campaign to raise awareness of medicine side effects, and the importance of reporting them. This year’s campaign focuses on polypharmacy, with the overarching message that reporting side effects helps […]
» read morePublic Notification on Health Supplements
October 24th, 2019Following the public notification issued by the Office of Consumer Protection on October 21, 2019 establishing MagneSSa Bhutan and Oriens Bhutan to be operating pyramid schemes, the Drug Regulatory Authority would like to notify the general public that Technical Authorization for Sale & Distribution of Medicines issued to Oriens Bhutan is cancelled along with 23 […]
» read moreComments for Draft Bhutan Medicines Rules and Regulation 2019
August 1st, 2019Drug Regulatory Authority is coming up with 4th edition of Bhutan Medicines Rules and Regulation. The revision of the regulation is mainly carried out to incorporate new regulatory provisions based on the current scenario in the market and institutions dealing with the medicinal products. This regulation also covers the regulatory provisions of Health Supplement and […]
» read more