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Regulation of therapeutic goods

The regulation of therapeutic goods, defined as 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 in Australia.

For laws prohibiting other drugs, see Prohibition of drugs.

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 sold. There is usually some degree of restriction on the availability of certain therapeutic goods, depending on their risk to consumers.

unscheduled substances: unscheduled substances are available for purchase at any retailer.

schedule 1 (S1) - Blank: this schedule is left intentionally blank.

schedule 2 (S2) - Pharmacy medicines: substances in schedule 2 are only available for purchase in a pharmacy or other licensed retailer.

schedule 3 (S3) - Pharmacist only medicines: substances in schedule 3 are only available for purchase in a pharmacy and a pharmacist must be involved in the sale of the medicine.

schedule 4 (S4) - Prescription only medicines and prescription animal remedies: substances in schedule 4 are only available with a prescription from a prescriber (medical practitioners, dentists, nurse practitioners, endorsed physiotherapists and podiatrists) and must be purchased at a pharmacy.

schedule 5 (S5) - Caution

schedule 6 (S6) - Poisons

schedule 7 (S7) - Dangerous Poisons

schedule 8 (S8) - Controlled drugs: substances in schedule 8 are generally drugs of addiction or dependence and are only available with a prescription from an authorised prescriber, they must be purchased at a pharmacy. Schedule 8 medicines have additional controls on their storage, supply, possession, destruction and prescription compared to schedule 4 substances.

schedule 9 (S9) - Prohibited substances

schedule 10 (S10) - Substances of such danger to health as to warrant prohibition of supply and use

(CIOMS, WHO)

Council for International Organizations of Medical Sciences

Counterfeit drug

(DESI)

Drug Efficacy Study Implementation

and Drug prohibition law

Drug policy

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

Inverse benefit law

List of stringent regulatory authorities

Over-the-counter drug

Prescription drug

(WHO)

Uppsala Monitoring Centre

Validation (drug manufacture)

World Health Organization

Legal drug trade

Illegal drug trade

Central Drugs Standard Control Organisation (India)

Presentation on Drug License Audit Process in India