The Online Encyclopedia and Dictionary






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 a 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 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.


United States

Therapeutic goods in the United States are regulated by the Food and Drug Administration (FDA). The availability of controlled drugs is regulated by scheduling under the Controlled Substances Act.


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:

  • Unscheduled/exempt
  • Schedule 2 (S2) - Pharmacy Only medicines
  • Schedule 3 (S3) - Pharmacist Only medicines
  • Schedule 4 (S4) - Prescription Only medicines
  • Schedule 8 (S8) - Controlled Drugs

United Kingdom

Medicines in the United Kingdom are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). The availability of drugs is regulated by classification by the Medicines Control Agency as part of marketing authorisation of a product.

The United Kingdom has a three-tiered classification system:

  • General Sale List (GSL)
  • Pharmacy medicines (P)
  • Prescription Only Medicines (POM)

Within POM, certain agents with a high abuse/addiction liability are separately scheduled under the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001; and are commonly known as Controlled Drugs (CD).

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Last updated: 05-15-2005 02:44:32
Last updated: 05-13-2005 07:56:04