تنظيم السلع العلاجية
تنظيم البضائع العلاجية أو تصريح التسويق هي الموافقة المعطات لدواء من أجل تسويقه.
عندما يرغب مخبر صيدلاني في بيع مواد صحية (أدوية ، كواشف اٍلخ) ، يجب عليه أن يقدم ملف للسلطة المكلفة بالبلد.
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التاريخ
Modern drug regulation has historical roots in the response to the proliferation of universal antidotes which appeared in the wake of Mithridates' death.[1] Mithridates had brought together physicians, scientists, and shamans to concoct a potion that would make him immune to poisons. Following his death, the Romans became keen on further developing the Mithridates potion's recipe. Mithridatium re-entered western society through multiple means. The first was through the Leechbook of the Bald (Bald's Leechbook), written somewhere between 900 and 950, which contained a formula for various remedies, including for a theriac. 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. Additionally, the creation of these concoctions took on ritualistic form and were often created in public and the process was observed and recorded. 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.[2]
In the ninth century, many Muslim countries established an office of the hisba, which in addition to regulating compliance to Islamic principles and values took on the role of regulating other aspects of social and economic life, including the regulation of medicines. 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.[3] The first official 'act', the 'Apothecary Wares, Drugs and Stuffs' Act (also sometimes referred to as the 'Pharmacy Wares, Drugs and Stuffs' Act) was passed in 1540 by Henry VIII and set the foundation for others. Through this act, he encouraged physicians in his College of Physicians (founded by him in 1518) to appoint four people dedicated to consistently inspecting what was being sold in apothecary shops.[2] In conjunction with this first piece of legislation, there was an emergence of standard formulas for the creation of certain 'drugs' and 'antidotes' through Pharmacopoeias which first appeared in the form of a decree from Frederick II of Sicily in 1240 to use consistent and standard formulas.[4] The first modern pharmacopoeias were the Florence Pharmacopoeia published in 1498,[2] the Spanish Pharmacopoeia published in 1581 and the London Pharmacopoeia published in 1618.[5]
Various other events throughout history have demonstrated the importance of drug and medicine regulation keeping up with scientific advances. 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. Rofecoxib represents a drug that was on the market that had not clearly represent the risks associated with the use drug which led to the concept of 'risk management planning' within the field of regulation by introducing the need to understand how various safety concerns would be managed. Various cases over recent years have demonstrated the need for regulation to keep up with scientific advances that have implications for people's health.[6]
الولايات المتحدة
In the United States, regulation of drugs was originally a state right, as opposed to federal right. But with the increase in fraudulent practices due to private incentives to maximize profits and poor enforcement of state laws, the need for stronger federal regulation increased.[7] In 1906 President Roosevelt signed the Federal Food and Drug Act (FFDA) which both established stricter national standards for drug manufacture and sales, and also established the Federal government as the regulating authority over the US drug industry.[7] A 1911 Supreme Court decision, United States vs. Johnson, established that misleading statements were not covered under the FFDA. This directly led to Congress passing the Sherley Amendment which established a clearer definition of 'drug marketing requirements'.[7]
More catalysts for advances in drug regulation in the US were certain catastrophes that served as calls to the US government to step in and impose regulations that would prevent repeats of those instances. One such instance occurred in 1937 when more than a hundred people died from using sulfanilamide elixir which had not gone through any safety testing.[7][4] This directly led to the passing of the Federal, Food, Drug, and Cosmetic Act in 1938. One other major catastrophe occurred in the late 1950s when Thalidomide, which was originally sold in Germany (introduced into a virtually unregulated market) and eventually sold around the world, led to approximately 100,000 babies being born with various deformities.[4] In 1962 the United States Congress passed the Drug Amendments Act of 1962. The Drug Amendments Act required the FDA to ensure that new drugs being introduced to the market had passed certain tests and standards.[7]
المملكة المتحدة
The UK's Chief Medical Officer had established a group to look into safety of drugs on the market in 1959 prior to the crisis and was moving in the direction of address the problem of unregulated drugs entering the market. The crisis created a greater sense of emergency to establish safety and efficacy standards around the world. The UK started a temporary Committee on Safety of Drugs while they attempted to pass more comprehensive legislation. Though compliance and submission of drugs to the Committee on Safety of Drugs was not mandatory immediately after, the pharmaceutical industry later complied due to the thalidomide situation.
الاتحاد الاقتصادي الأوروپي
The European Economic Commission also passed a directive in 1965 in order to impose greater efficacy standards before marketing a drug.[6] Drug legislation in both the EU and US were passed in order to assure drug safety and efficacy. Of note, increased regulations and standards for testing actually led to greater innovation in pharmaceutical research in the 1960s, despite greater preclinical and clinical standards.[6] In 1989, the International Conference of Drug Regulatory Authorities organized by the WHO, officials from around the world discussed the necessity for streamlined processes for global drug approval.[4]
انظر أيضاً
- Council for International Organizations of Medical Sciences (CIOMS, WHO)
- دواء مغشوش
- Drug Efficacy Study Implementation (DESI)
- قانون حظر العقاقير
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
- Over-the-counter drug
- دواء بوصفة
- Uppsala Monitoring Centre (WHO)
- Validation (drug manufacture)
- منظمة الصحة العالمية
- Legal drug trade
- Illegal drug trade
الهامش
- ^ Silver, Carly (10 January 2017). "How Ancient Cure-Alls Paved the Way for Drug Regulation". The Atlantic.
- ^ أ ب ت ث Griffin, J P (2004). "Venetian Treacle and the Foundation of Medicines Regulation". British Journal of Clinical Pharmacology. 58 (3): 317–325. doi:10.1111/j.1365-2125.2004.02147.x. PMC 1884566. PMID 15327592.
- ^ Penn, Rg (1979). "The State Control of Medicines: The First 3000 Years". British Journal of Clinical Pharmacology. 8 (4): 293–305. doi:10.1111/j.1365-2125.1979.tb04710.x. PMC 1429842. PMID 389263.
- ^ أ ب ت ث van Boxtel, C.J. (2008). Drug Benefits and Risks: International Textbook of Clinical Pharmacology.
- ^ Valverde, Jose Luis (2007). Key Issues in Pharmaceuticals Law. Washington D.C.: IOS Press.
- ^ أ ب ت Emanuel, Michael (2012). "Thalidomide and its sequelae". The Lancet. 380 (9844): 781–783. doi:10.1016/s0140-6736(12)60468-1. PMID 22939670. S2CID 13244162.
- ^ أ ب ت ث ج Clark, Michael (2015). Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing. Bloomberg BNA.