Regulation of therapeutic goods
Modern drug regulation has historical roots in the response to the proliferation of universal antidotes which appeared in the wake of Mithridates' death.
Additionally, theriac became a commercial good traded throughout Europe based on the works of Greek and Roman physicians.
[2] The resulting proliferation of various recipes needed to be curtailed in order to ensure that people were not passing off fake antidotes, which led to the development of government involvement and regulation.
It was believed that if the concoction proved unsuccessful, it was due to the apothecaries' process of making them and they could be held accountable because of the public nature of the creation.
Inspectors were appointed to employ oversight on those who were involved in the process of medicine creation and were given a lot of leeway to ensure compliance and punishments were stringent.
In 2006, the challenges associated with TGN 1412 highlighted the shortcomings of animal models and paved the way for further advances in regulation and development for biological products.
Various cases over recent years have demonstrated the need for regulation to keep up with scientific advances that have implications for people's health.
[7] A 1911 Supreme Court decision, United States vs. Johnson, established that misleading statements were not covered under the FFDA.
[citation needed] The European Economic Commission also passed a directive in 1965 in order to impose greater efficacy standards before marketing a drug.
[9] The Poisons Standard organises substances into 10 schedules (and unscheduled substances),[10] therapeutic goods are generally organised only into schedules 2, 3, 4 and 8: Therapeutic goods in Brazil are regulated by the Ministry of Health of Brazil, through its Brazilian Health Regulatory Agency (Anvisa), equivalent to the US Food and Drug Administration.
[18] In Ontario, the Drug and Pharmacies Regulation Act governs "any substance that is used in the diagnosis, treatment, mitigation or prevention of a disease...in humans, animals or fowl.
[21] Medicines in India are regulated by Central Drugs Standard Control Organization (CDSCO) Under Ministry of Health and Family Welfare.
Drugs are divided into five groups: Narcotics, sedative-hypnotics, and amphetamines in this class require a special prescription form: Restricted substances which easily lead to addiction like: co-codamol, tramadol, diazepam, nitrazepam and all other benzodiazepines (with the exception of temazepam and flunitrazepam) phentermine.
The country is not part of the European Union, and is regarded by many as one of the easiest places to conduct clinical trials on new drug compounds.
Some US states apply more stringent limits on the prescription of certain controlled substances C-V and BTC (behind the counter) drugs such as pseudoephedrine.
Three primary branches of pharmacovigilance in the U.S. include the FDA, the pharmaceutical manufacturers, and the academic/non-profit organizations (such as RADAR and Public Citizen).
