Tanis Technical Inc. - Validation Services and GMP Compliance

Regulatory Agencies

A list of links to various government regulators. Links will open in a new window.

#	Web Link
1	US Food and Drug Administration (FDA) The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
2	Health Canada Health Canada is the Federal department responsible for helping Canadians maintain and improve their health, while respecting individual choices and circumstances.
3	International Conference on Harmonisation (ICH) The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
4	Medicines and Healthcare products Regulatory Agency (UK) The MHRA enhances and safeguards the health of the public by ensuring that medicines and medical devices work and are acceptably safe. No product is risk free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.
5	Ministry of Health, Labour and Welfare (Japan) Ministry of Health, Labour and Welfare (Japan)
6	California Food and Drug Branch The Food and Drug Branch mission is to protect and improve the health of all California residents by assuring that foods, drugs, medical devices, cosmetics and certain other consumer products are safe and are not adulterated, misbranded nor falsely advertised; and that drugs and medical devices are effective.
7	European Medicines Agency The European Medicines Agency (EMA) is a decentralised body of the European Union, located in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.
8	National Bureau of Controlled Drugs, Department of Health, Taiwan The vision of the Department of Health has always been set on establishing “A Healthy Taiwan – Providing the Public a Healthy and Safe Lifestyle.” The department also promotes medical education, health care, and disease prevention, as well as food, drug,and cosmetic management and health insurance affairs. Our main responsibilities are very closely related to the daily lives of the public. The department also upholds the values of “abiding by the law and pragmatism, enriching the lives of and loving the people,” as well as achieving the four main missions of “serving as a catalyst in improving the health of the people, educating the people toward a healthy lifestyle, paving the road for the health industry, and participating in international health affairs.” Under the 2005 to 2008 medium-term projects of the department, six strategic performance goals have successfully been established - “improving the quality of health care”, “integrating health management into our lifestyle”, “making disease prevention a public responsibility”, “making food and drugs safe”, “industrializing health technology”, and “making health affairs an international issue”.