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.

Australia

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 Medicines
Schedule 3 (S3) - Pharmacist Only Medicines
Schedule 4 (S4) - Prescription Only Medicines
Schedule 8 (S8) - Controlled Drugs

Brazil

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

Normal Medicines - Cough, cold and fever medicines, Antiseptics, vitamins and others. Sold freely in pharmacies and some large supermarkets.
Red Stripe Medicines - These medicines are sold only with medical prescription. Antibiotics, Anti allergenics, Anti inflamatories, and other medicines. In Brazil the State control is loosen in this type, been common to buy over the counter in pharmacies without a prescription.
Red Stripe Psychoactive Medicines - These medicines are sold only with a "Special Control" white medical prescription with carbon copy, which is valid for 30 days. The original must be retained by the pharmacist after the sale and the patient keeps the carbon copy. Anti depressives, Anti convulsants, some sleep inducers and anti psychotics and other non habit inducing controlled medicines. Though some consider them habit inducing, anabolic steroids are also regulated under these category.
Black Stripe Medicines - These medicines are sold only with the "Blue B Form" medical prescription, which is valid for 30 days and must be retained by the pharmacist after the sale. Sedatives (benzodiazepines), some anorexic inducers and other habit inducing controlled medicines.
"Yellow A Form" prescription medicines - These medicines are sold only with the "Yellow A Form" medical prescription - the most tightly controlled, which is valid for 30 days and must be retained by the pharmacist after the sale. Amphetamines (such as Ritalin), opioids (such as morphine and oxicodone) and other strong habit inducing controlled medicines.

External Link: http://www.anvisa.gov.br/eng/institution/history.htm

European Union

See European Medicines Agency.

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).

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.

The United States has a two-tiered system:

Over the counter (OTC)
Prescription only (℞-only)

External links

Medicines Control Agency (UK)

Pharmacy