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The Act authorizes several subsidiary organizations, including the Bhutanese Drug Regulatory Authority, Drug Testing Laboratory, and teams of Drug Inspectors. These agencies have rulemaking and law enforcement authority on drugs, medicines, and even price controls, but must operate within the laws of Bhutan. [14]
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
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The Food and Drug Board of Authority (Burmese: အစားအသောက်နှင့် ဆေးဝါးကွပ်ကဲရေး ဦးစီးဌာန; abbreviated FDBA) is Burma's national regulatory agency, responsible for regulation of therapeutic goods, including the manufacture, import, export, storage, distribution and sale of food and drugs, in the interests of public ...
The two traditions of traditional and allopathic medicine are fundamental to the history of Bhutan's health services. Few credible accounts exist of the first Indian-trained doctors and paramedics bringing western medicine to the kingdom in the early 20th century, but as early as the 7th century, Bhutanese people were using Sowa Rigpa, or traditional medicine, which is based on Tibetan medical ...
The Bhutan InfoComm and Media Authority (BICMA) is the result of the merger of the Media Council of Bhutan and the National Film Commission. It will function as the secretariat for the Authority and be administratively under the MoICE. Likewise, the Bhutan Standards Bureau has been merged into the MoICE and will serve as the Bureau's ...
The Tobacco Control Board is the same body as the preexisting Bhutan Narcotic Control Board, now charged with regulating tobacco and enforcing that regulation under the act. The board provides guidance and direction to the Tobacco Control Office and other law enforcement agencies regarding tobacco law enforcement and is permitted to propose ...
The MHRA and the US Food and Drug Administration were criticised in the 2012 book Bad Pharma, [43] and in 2004 by David Healy in evidence to the House of Commons Health Committee, [44] for having undergone regulatory capture, i.e. advancing the interests of the drug companies rather than the interests of the public.