Regulation of therapeutic goods

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]


Overview

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, governmental control is loose on this type; it is not uncommon to buy this type of prescription medicine over the counter 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. Drugs include anti-depressants, anti-convulsants, some sleep aids, anti-psychotics and other non-habit-inducing controlled medicines. Though some consider them habit inducing, anabolic steroids are also regulated under this 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. Includes 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. Includes amphetamines and other stimulants (such as methylphenidate), opioids (such as morphine and oxycodone) and other strong habit-forming controlled medicines. ([2])

European Union

See EudraLex, European Medicines Agency, and Directive 65/65/EEC1.

India

Medicines in India are regulated by The Drugs Controller General of India (DCGI). http://www.cdsco.nic.in/

Norway

Medicines in Norway are divided into five groups:

  • Class A - Narcotics like Morphine and Ritalin require a special prescription form.
  • Class B - Restricted substances which easily lead to addiction like Paralgin Forte and Valium
  • Class C - All prescription-only substances
  • Class F - Substances and package-sizes not requiring a prescription
  • Unclassifieds - Brands and packages not actively marketed in Norway

Switzerland

Medicines in Switzerland are regulated by SwissMedic (http://www.swissmedic.ch/?lang=2&lang_old=2). The country is NOT part of the EU (as of 2007), and thus is regarded as many as one of the easiest places to conduct clinical trials on new drug compounds.

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 MHRA 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 (Rx-only)

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