Regulation of therapeutic goods

The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as is the case in Australia.

The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be marketed. There is usually some degree of restriction of the availability of certain therapeutic goods depending on their risk to consumers.

Therapeutic goods in Australia are regulated by the Therapeutic Goods Administration (TGA). The availability of drugs and poisons is regulated by scheduling under individual state legislation, but is generally under the guidance of the national Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP).

Under the SUSDP, medicinal agents generally belong to one of five categories:

Therapeutic goods in Brazil are regulated by the Brazilian Health Ministry, through its National Health Surveillance Agency (equivalent to USA's FDA). There are 5 main categories:

In Canada, regulation of therapeutic goods are governed by the Food and Drug Act and associated regulations. In addition, the Controlled Drugs and Substances Act requires additional regulatory requirements for controlled drugs and drug precursors.

The regulation of drugs in Burma is governed by the Food and Drug Administration (Burma) and Food and Drug Board of Authority.

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