Knowledge (XXG)

Regulation of therapeutic goods

Source 📝

103:, 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. 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 38: 479:(EMA). EMA and the Member States cooperate and share expertise in the assessment of new medicines and of new safety information. They also rely on each other for exchange of information in the regulation of medicine, for example regarding the reporting of side effects of medicines, the oversight of clinical trials, and the conduct of inspections of medicines' manufacturers and compliance with 195:(TGA), which is a regulatory body of the Commonwealth Department of Health. Access to medicines and poisons is regulated by the separation of substances into various schedules according to the Therapeutic Goods (Poisons Standard) Instrument, the Poisons Standard may also be cited as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). 163:
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.
1256: 80:' death. 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 172:
led to greater innovation in pharmaceutical research in the 1960s, despite greater preclinical and clinical standards. 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.
67:
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
127:
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
171:
The European Economic Commission also passed a directive in 1965 in order to impose greater efficacy standards before marketing a drug. 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
149:
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. In 1962 the United
136:
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. In 1906 President
93:
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
162:
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
227:
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,
144:
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
214:
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
107:(founded by him in 1518) to appoint four people dedicated to consistently inspecting what was being sold in apothecary shops. In conjunction with this first piece of legislation, there was an emergence of standard formulas for the creation of certain 'drugs' and 'antidotes' through 137:
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. A 1911 Supreme Court decision,
483:(GCP), good manufacturing practice (GMP), good distribution practice (GDP), and good pharmacovigilance practice (GVP). EU legislation requires that each Member State operates to the same rules and requirements regarding the authorisation and monitoring of medicines. 796:, etc. Prescriptions must be handwritten and are only valid for 14 days. Repeat prescriptions are not permitted. Drugs must comply with safe custody and destruction of unsold/unused medication must be witnessed. Must be registered in a Controlled Drugs register. 329:"Yellow A form" prescription medicines: 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 94:
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.
306:
Red stripe psychoactive medicines: sold only with a "special control" white medical prescription with patient's copy, which is valid for 30 days. The original must be retained by the pharmacist after the sale and the patient keeps the copy. Drugs include
90:), 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. 474:
The European Union (EU) medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and
1910: 115:
in 1240 to use consistent and standard formulas. The first modern pharmacopoeias were the Florence Pharmacopoeia published in 1498, the Spanish Pharmacopoeia published in 1581 and the London Pharmacopoeia published in 1618.
141:, 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'. 302:
are sold only with a "special control" white medical prescription with patient's copy, which is valid for 10 days. The original must be retained by the pharmacist after the sale and the patient keeps the
398: 1561: 1230: 2189: 315:, 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. 1614: 119:
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
68:
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.
60:, 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 1897: 1968: 694: 211:
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.
1811: 1769: 1727: 1663: 1142: 374:
Vaccines: immunobiological medications that contain one or more antigenic substances capable of inducing immunity to protect against disease, reduce its severity or fight it
318:
Black stripe medicines: 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
2159: 348:
are complex molecules of high molecular weight obtained from a biological source or biotechnological procedures and are divided by Anvisa into the following categories:
1747: 1562:
https://www.tga.gov.au/how-we-regulate/ingredients-and-scheduling-medicines-and-chemicals/poisons-standard-and-scheduling-medicines-and-chemicals/poisons-standard-susmp
2163: 2155: 198:
The Poisons Standard organises substances into 10 schedules (and unscheduled substances), therapeutic goods are generally organised only into schedules 2, 3, 4 and 8:
397:
COVAX Facility: temporarily lifts the requirement of registration or emergency use authorization for vaccines purchased by the Ministry of Health that are under the
2167: 2151: 2296: 1996: 244: 1705: 2084: 2114: 1641: 1214: 645: 2051: 1082: 1266: 181: 1875: 2199: 1677: 2234: 649: 123:
highlighted the shortcomings of animal models and paved the way for further advances in regulation and development for biological products.
1610: 154:. The Drug Amendments Act required the FDA to ensure that new drugs being introduced to the market had passed certain tests and standards. 851: 731: 146: 378:
The regulatory status of vaccines, which determines their marketing and distribution, may be one of the following established by Anvisa:
2142: 425: 208:
schedule 2 (S2) - Pharmacy medicines: substances in schedule 2 are only available for purchase in a pharmacy or other licensed retailer.
128:
recent years have demonstrated the need for regulation to keep up with scientific advances that have implications for people's health.
1241: 452: 439:
governs "any substance that is used in the diagnosis, treatment, mitigation or prevention of a disease...in humans, animals or fowl."
254: 76:
Modern drug regulation has historical roots in the response to the proliferation of universal antidotes which appeared in the wake of
1843: 1179: 1167: 867: 653: 2026: 1587: 855: 192: 112: 1205:
apply more stringent limits on the prescription of certain controlled substances C-V and BTC (behind the counter) drugs such as
2291: 2286: 2224: 2219: 2107: 1198: 61: 1145:(MHRA). The availability of drugs is regulated by classification by the MHRA as part of marketing authorisation of a product. 2204: 1741: 747:. Controlled drugs (CDs) are divided into five categories based on their potential for misuse and therapeutic effectiveness. 1849: 1287: 744: 627: 436: 258: 2030: 1973: 389: 250: 2004: 1257:
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
359:
Monoclonal antibodies: immunoglobulins derived from the same B lymphocyte clone, propagated in continuous cell lines
17: 2100: 1699: 1213:
in the U.S. include the FDA, the pharmaceutical manufacturers, and the academic/non-profit organizations (such as
2276: 2147: 1905: 1680:[Requirements for vaccine approval] (in Portuguese). Federal government of Brazil. Anvisa. 20 August 2020 1292: 1281: 1194: 881: 577: 491: 476: 362:
Biomedicines: obtained from biological fluids or tissues of animal origin or through biotechnological procedures
2239: 1635: 1163: 549: 77: 2055: 490:
maintains the collection of rules and regulations governing medicinal products in the European Union, and the
2214: 1789: 405: 151: 145:
sulfanilamide elixir which had not gone through any safety testing. This directly led to the passing of the
365:
Blood derivatives: obtained from human plasma, subjected to industrialization and standardization processes
652:. Headed by Directorate General of Health Services(India).CDSCO regulates pharmaceutical products through 480: 1162:
Within POM, certain agents with a high abuse/addiction liability are also separately scheduled under the
1113:, and is regarded by many as one of the easiest places to conduct clinical trials on new drug compounds. 1871: 1271: 1183: 265: 677:
Schedule N - list of the equipment for the efficient running of manufacturing wing, qualified personnel
2281: 2194: 1251: 639: 536: 531: 522: 510: 504: 498: 31: 1261: 829: 516: 277: 234:
schedule 10 (S10) - Substances of such danger to health as to warrant prohibition of supply and use
86: 1942: 1509: 1302: 723:), prescription only medicine. Marked by red circle with letter "K" inside circle and black line. 1613:[Medications - Concepts and definitions] (in Portuguese). Federal government of Brazil. 494:
acts to regulate many of these rules and regulations. Amongst these rules and regulations are:
368:
Probiotics: preparations containing viable microorganisms in sufficient quantity to change the
1839: 1805: 1763: 1721: 1657: 1501: 1424: 1375: 1276: 1210: 1187: 591: 585: 421: 345: 292: 1493: 1414: 1406: 1365: 1357: 1322:
Silver, Carly (10 January 2017). "How Ancient Cure-Alls Paved the Way for Drug Regulation".
1297: 1236: 353: 37: 1831: 1206: 1001: 817: 766:, etc. Use is prohibited except in limited circumstances where a license has been granted. 526: 330: 323: 312: 308: 202:
unscheduled substances: unscheduled substances are available for purchase at any retailer.
41: 1573: 1538:
Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing
352:
Allergens: substances from animals or plants that can induce an IgE response or a type I
1595: 1419: 1410: 1394: 1370: 1345: 1218: 1110: 1038: 910: 428:
specifies additional regulatory requirements for controlled drugs and drug precursors.
1497: 2270: 1835: 1361: 1193:
The prescription or possession of some substances is controlled or prohibited by the
1116:
There are five categories from A to E to cover different types of delivery category:
1042: 1007: 982: 925: 914: 807: 417: 383: 108: 1513: 588:("neue psychoaktive Stoffe" – permitted only for industrial and scientific purposes) 513:, requires marketing authorization requests to be drawn up only by qualified experts 986: 978: 900: 896: 603: 2092: 507:, clarifies requirements of 65/65/EEC1 and requires member states to enforce them 2079: 1247: 1086: 1046: 997: 963: 936: 929: 918: 773: 759: 705:), drugs freely available to the public. Marked by green circle with black line. 299: 64:
level, or at both state and national levels by various bodies, as in Australia.
1825: 1166:(amended with the Misuse of Drugs Regulations 2001); and are commonly known as 1202: 1106: 1034: 1022: 825: 793: 573: 369: 281: 810:, etc. As CD2, except witnessed destruction and CD register are not required. 291:
Red stripe medicines: sold only with medical prescription. Anti-allergenics,
1963: 993: 974: 955: 951: 940: 803: 789: 777: 763: 690: 567: 319: 124: 1748:"RESOLUÇÃO RDC NÂș 465, DE 9 DE Fevereiro DE 2021 - DOU - Imprensa Nacional" 1505: 1379: 734:
perform law enforcement measure at illegal drug abuse and drug trafficking.
228:
possession, destruction and prescription compared to schedule 4 substances.
539:, defines Good Clinical Practice for design and conduct of clinical trials 519:, establishes the European Agency for the Evaluation of Medicinal Products 2184: 1428: 1030: 1026: 970: 959: 888: 821: 785: 781: 755: 659:
Drugs are classified under five headings. Under retail and distribution:
561: 501:, requires prior approval for marketing of proprietary medicinal products 487: 338: 97:
In the ninth century, many Muslim countries established an office of the
1874:. The Ontario College of Pharmacists. Pharmacy Connection. 25 May 2018. 1451:
Drug Benefits and Risks: International Textbook of Clinical Pharmacology
880:
Narcotics, sedative-hypnotics, and amphetamines in this class require a
669:
Schedule C and C1 - biological products, for example serums and vaccines
326:), some anorexic inducers and other habit-inducing controlled medicines. 947: 906: 838: 432: 334: 285: 120: 892: 99: 1550: 1097:
Prohibited. Brands and packages not actively marketed in Sri Lanka.
1574:"Therapeutic Goods (Poisons Standard—October 2023) Instrument 2023" 1141:
Medicines for Human Use in the United Kingdom are regulated by the
341:
and oxycodone) and other strong habit-forming controlled medicines.
205:
schedule 1 (S1) - Blank: this schedule is left intentionally blank.
36: 1783: 1706:"LEI NÂș 14.124, DE 10 DE MARÇO DE 2021 - DOU - Imprensa Nacional" 716:) or licensed drug stores. Marked by blue circle with black line. 1786:(in Portuguese). Ministry of Health of Brazil. 26 December 2017. 1638:(in Portuguese). Ministry of Health of Brazil. 16 December 2010. 1120:
A: Supply once with a prescription from a doctor or veterinarian
2096: 1744:(in Portuguese). Ministry of Health of Brazil. 9 February 2010. 464: 448: 1346:"Venetian Treacle and the Foundation of Medicines Regulation" 1148:
The United Kingdom has a three-tiered classification system:
1702:(in Portuguese). National Congress of Brazil. 10 March 2021. 1178:
Therapeutic goods in the United States are regulated by the
1997:"Penggolongan Obat Berdasarkan Penandaan pada Kemasan Obat" 1231:
Council for International Organizations of Medical Sciences
1123:
B: Supply with a prescription from a doctor or veterinarian
1064:- Substances and package-sizes not requiring a prescription 1021:
Restricted substances which easily lead to addiction like:
666:
Schedule H and L - injectables, antibiotics, antibacterials
1484:
Emanuel, Michael (2012). "Thalidomide and its sequelae".
712:), drugs available to the public only through pharmacy ( 388:
Temporary emergency use authorization: similar to a US
1934: 1395:"The State Control of Medicines: The First 3000 Years" 416:
In Canada, regulation of therapeutic goods is done by
399:
Emergency Use Listing of the World Health Organization
1969:
National Agency of Drug and Food Control of Indonesia
1072:- Brands and packages not actively marketed in Norway 695:
National Agency of Drug and Food Control of Indonesia
176:
Regulatory authorities and key legislation by country
1872:"Similar, But Different: Veterinary and Human Drugs" 850:
The regulation of drugs in Burma is governed by the
743:
Medicines in Ireland are regulated according to the
463:
The regulation of drugs in Egypt is governed by the
447:
The regulation of drugs in China is governed by the
191:
Therapeutic goods in Australia are regulated by the
18:
Regulation of therapeutic goods in the United States
2248: 2177: 2130: 2085:
Presentation on Drug License Audit Process in India
2080:
Central Drugs Standard Control Organisation (India)
1678:"Saiba o que é exigido para a aprovação de vacinas" 1143:
Medicines and Healthcare products Regulatory Agency
27:
Legal management of drugs and restricted substances
111:which first appeared in the form of a decree from 2054:. Federal Office of Public Health. Archived from 249:Therapeutic goods in Brazil are regulated by the 1810:: CS1 maint: bot: original URL status unknown ( 1792:. Archived from the original on 21 November 2021 1768:: CS1 maint: bot: original URL status unknown ( 1750:. Archived from the original on 20 November 2021 1726:: CS1 maint: bot: original URL status unknown ( 1708:. Archived from the original on 20 November 2021 1662:: CS1 maint: bot: original URL status unknown ( 1644:. Archived from the original on 20 November 2021 1126:C: Supply on technical advice from medical staff 594:("verschreibungspflichtig" or "rezeptpflichtig") 1588:"Background of Sanitary Surveillance in Brazil" 570:BTMG (authorized trade only, not prescriptible) 449:National Medical Products Administration (NMPA) 382:Sanitary vaccine registration: definitive, for 1898:"The European regulatory system for medicines" 1594:. Federal Government of Brazil. Archived from 2108: 2027:"Controlled Drugs | Irish Medical Times" 424:and associated regulations. In addition, the 245:Brazilian Controlled Drugs and Substances Act 8: 600:General sales list drugs ("freiverkĂ€uflich") 408:or authorized private vaccination services. 404:Vaccines can only be administered in public 1085:regulates drugs and medical devices in the 646:Central Drugs Standard Control Organization 2115: 2101: 2093: 1105:Medicines in Switzerland are regulated by 697:. Drugs in Indonesia are classified into: 626:Medicines in Iceland are regulated by the 597:Pharmacy-only drugs ("apothekenpflichtig") 1418: 1369: 866:Medicines in Norway are regulated by the 1827:Health Canada: Drugs and Health Products 1399:British Journal of Clinical Pharmacology 1350:British Journal of Clinical Pharmacology 1267:List of stringent regulatory authorities 1182:(FDA), which makes some drugs available 182:List of stringent regulatory authorities 1592:AgĂȘncia Nacional de Segurança SanitĂĄria 1314: 231:schedule 9 (S9) - Prohibited substances 1976:from the original on 21 September 2021 1878:from the original on 18 September 2021 1803: 1761: 1719: 1655: 1186:(OTC) at retail outlets and others by 870:. Drugs are divided into five groups: 288:and others. Sold freely in pharmacies. 30:For laws prohibiting other drugs, see 2297:National agencies for drug regulation 1611:"MedicaçÔes - Conceitos e definiçÔes" 1041:(with the exception of temazepam and 650:Ministry of Health and Family Welfare 564:BTMG (authorized scientific use only) 147:Federal, Food, Drug, and Cosmetic Act 7: 1609:Brazilian Health Regulatory Agency. 1531: 1529: 1527: 1525: 1523: 1479: 1477: 1475: 1444: 1442: 1440: 1438: 1339: 1337: 1335: 1333: 852:Food and Drug Administration (Burma) 644:Medicines in India are regulated by 609:Kategorie 1 (authorization required) 580:required – "BetĂ€ubungsmittelrezept") 280:): cough, cold and fever medicines, 525:, defines rules for the conduct of 426:Controlled Drugs and Substances Act 224:schedule 7 (S7) - Dangerous Poisons 1411:10.1111/j.1365-2125.1979.tb04710.x 1242:Drug Efficacy Study Implementation 1132:E: Supply without technical advice 1056:- All prescription-only substances 726:Narcotics and psychoactive drugs ( 628:Icelandic Medicines Control Agency 453:China Food and Drug Administration 437:Drug and Pharmacies Regulation Act 270:medicamentos isentos de prescrição 255:Brazilian Health Regulatory Agency 25: 1852:from the original on 28 July 2017 1551:https://www.tga.gov.au/tga-basics 1466:Key Issues in Pharmaceuticals Law 1180:U.S. Food and Drug Administration 1158:Prescription Only Medicines (POM) 1109:. The country is not part of the 868:Norwegian Medical Products Agency 654:Drugs Controller General of India 615:Kategorie 3 (export restrictions) 554:German law classifies drugs into 261:. There are six main categories: 2229: 1995:Kurniawan, Hadi (28 July 2020). 1362:10.1111/j.1365-2125.2004.02147.x 856:Food and Drug Board of Authority 745:Misuse of Drugs Regulations 1988 612:Kategorie 2 (reporting required) 394:Exceptional import authorization 193:Therapeutic Goods Administration 2124:Regulation of therapeutic goods 1945:from the original on 2023-03-07 1916:from the original on 2019-07-28 1784:Resolution 197/2017, Article 17 1617:from the original on 2021-11-20 1199:Drug Enforcement Administration 728:Obat psikotropika dan narkotika 558:Narcotics ("BetĂ€ubungsmittel") 257:(Anvisa), equivalent to the US 2255: 2052:"Supply of medicinal products" 1966:[General Guidelines]. 1742:Resolution 465/2021, Article 2 673:Under manufacturing practice: 44:, in the form of Ritalin pills 1: 1636:Resolution 55/2010, Article 4 1498:10.1016/s0140-6736(12)60468-1 1468:. Washington D.C.: IOS Press. 1288:Validation (drug manufacture) 1129:D: Supply on technical advice 701:Over-the-counter (OTC) drug ( 465:Egyptian Drug Authority (EDA) 1935:"Icelandic Medicines Agency" 1464:Valverde, Jose Luis (2007). 1209:. Three primary branches of 1083:Food and Drug Administration 663:Schedule X drugs - narcotics 259:Food and Drug Administration 251:Ministry of Health of Brazil 2209: 2137: 390:Emergency Use Authorization 152:Drug Amendments Act of 1962 150:States Congress passed the 2313: 1939:Icelandic Medicines Agency 1700:Act 14124/2021, Article 13 909:and its immediate family, 891:and its immediate family, 637: 547: 451:which replaced the former 242: 179: 29: 2001:University of Tanjungpura 1906:European Medicines Agency 1449:van Boxtel, C.J. (2008). 1293:World Health Organization 1282:Uppsala Monitoring Centre 1195:Controlled Substances Act 882:special prescription form 578:special prescription form 492:European Medicines Agency 477:European Medicines Agency 221:schedule 6 (S6) - Poisons 218:schedule 5 (S5) - Caution 139:United States vs. Johnson 1197:, under the FDA and the 1164:Misuse of Drugs Act 1971 732:National Narcotics Board 550:List of German drug laws 298:Red stripe antibiotics: 1536:Clark, Michael (2015). 1152:General Sale List (GSL) 606:for synthesizing drugs 167:European Economic Union 2292:Pharmaceuticals policy 2287:Life sciences industry 2150:(substance schedules: 1155:Pharmacy medicines (P) 830:(methyl)phenobarbitone 481:good clinical practice 346:Biological medications 295:, and other medicines. 113:Frederick II of Sicily 45: 1642:"MinistĂ©rio da SaĂșde" 1344:Griffin, J P (2004). 1272:Over-the-counter drug 105:College of Physicians 82:Leechbook of the Bald 40: 1598:on 10 February 2013. 1576:. 26 September 2023. 1252:Drug prohibition law 1010:(moved from class B) 924:morphine relatives: 640:Drug policy of India 537:Directive 2005/28/EC 532:Directive 2001/83/EC 523:Directive 2001/20/EC 511:Directive 75/319/EEC 505:Directive 75/318/EEC 499:Directive 65/65/EEC1 420:and governed by the 32:Prohibition of drugs 1790:"Legislação - SBIm" 1262:Inverse benefit law 935:codeine relatives: 719:Prescription drug ( 710:Obat bebas terbatas 517:Directive 93/41/EEC 293:anti-inflammatories 58:therapeutic devices 1303:Illegal drug trade 971:sedative-hypnotics 708:Limited OTC drug ( 592:Prescription drugs 586:Research chemicals 48:The regulation of 46: 2264: 2263: 2007:on 4 October 2021 1972:(in Indonesian). 1492:(9844): 781–783. 1393:Penn, Rg (1979). 1277:Prescription drug 1211:pharmacovigilance 1188:prescription only 693:are regulated by 656:(DCGI) at chair. 422:Food and Drug Act 268:(OTC) medicines ( 50:therapeutic goods 16:(Redirected from 2304: 2277:Drug control law 2117: 2110: 2103: 2094: 2067: 2066: 2064: 2063: 2048: 2042: 2041: 2039: 2038: 2029:. Archived from 2023: 2017: 2016: 2014: 2012: 2003:. Archived from 1992: 1986: 1985: 1983: 1981: 1960: 1954: 1953: 1951: 1950: 1931: 1925: 1924: 1922: 1921: 1915: 1902: 1894: 1888: 1887: 1885: 1883: 1868: 1862: 1861: 1859: 1857: 1822: 1816: 1815: 1809: 1801: 1799: 1797: 1787: 1780: 1774: 1773: 1767: 1759: 1757: 1755: 1745: 1738: 1732: 1731: 1725: 1717: 1715: 1713: 1703: 1696: 1690: 1689: 1687: 1685: 1674: 1668: 1667: 1661: 1653: 1651: 1649: 1639: 1632: 1626: 1625: 1623: 1622: 1606: 1600: 1599: 1584: 1578: 1577: 1570: 1564: 1559: 1553: 1548: 1542: 1541: 1540:. Bloomberg BNA. 1533: 1518: 1517: 1481: 1470: 1469: 1461: 1455: 1454: 1446: 1433: 1432: 1422: 1390: 1384: 1383: 1373: 1341: 1328: 1327: 1319: 1298:Legal drug trade 1237:Counterfeit drug 1184:over the counter 1168:Controlled Drugs 354:hypersensitivity 313:anti-convulsants 309:anti-depressants 266:Over-the-counter 87:Bald's Leechbook 21: 2312: 2311: 2307: 2306: 2305: 2303: 2302: 2301: 2267: 2266: 2265: 2260: 2244: 2173: 2126: 2121: 2090: 2076: 2071: 2070: 2061: 2059: 2050: 2049: 2045: 2036: 2034: 2025: 2024: 2020: 2010: 2008: 1994: 1993: 1989: 1979: 1977: 1962: 1961: 1957: 1948: 1946: 1933: 1932: 1928: 1919: 1917: 1913: 1900: 1896: 1895: 1891: 1881: 1879: 1870: 1869: 1865: 1855: 1853: 1846: 1832:Ottawa, Ontario 1824: 1823: 1819: 1802: 1795: 1793: 1788: 1782: 1781: 1777: 1760: 1753: 1751: 1746: 1740: 1739: 1735: 1718: 1711: 1709: 1704: 1698: 1697: 1693: 1683: 1681: 1676: 1675: 1671: 1654: 1647: 1645: 1640: 1634: 1633: 1629: 1620: 1618: 1608: 1607: 1603: 1586: 1585: 1581: 1572: 1571: 1567: 1560: 1556: 1549: 1545: 1535: 1534: 1521: 1483: 1482: 1473: 1463: 1462: 1458: 1448: 1447: 1436: 1392: 1391: 1387: 1343: 1342: 1331: 1321: 1320: 1316: 1311: 1227: 1207:pseudoephedrine 1201:(DEA). Some US 1176: 1139: 1103: 1095: 1079: 1039:benzodiazepines 1002:methylphenidate 864: 848: 846:Myanmar (Burma) 818:benzodiazepines 741: 687: 642: 636: 624: 552: 546: 527:clinical trials 486:Within the EU, 472: 461: 445: 414: 331:methylphenidate 324:benzodiazepines 247: 241: 189: 184: 178: 169: 160: 134: 74: 42:Methylphenidate 35: 28: 23: 22: 15: 12: 11: 5: 2310: 2308: 2300: 2299: 2294: 2289: 2284: 2279: 2269: 2268: 2262: 2261: 2259: 2258: 2252: 2250: 2246: 2245: 2243: 2242: 2240:United Kingdom 2237: 2232: 2227: 2222: 2217: 2212: 2207: 2202: 2197: 2192: 2187: 2185:European Union 2181: 2179: 2175: 2174: 2172: 2171: 2145: 2140: 2134: 2132: 2128: 2127: 2122: 2120: 2119: 2112: 2105: 2097: 2088: 2087: 2082: 2075: 2074:External links 2072: 2069: 2068: 2043: 2018: 1987: 1964:"Pedoman Umum" 1955: 1926: 1889: 1863: 1844: 1817: 1775: 1733: 1691: 1669: 1627: 1601: 1579: 1565: 1554: 1543: 1519: 1471: 1456: 1434: 1405:(4): 293–305. 1385: 1356:(3): 317–325. 1329: 1313: 1312: 1310: 1307: 1306: 1305: 1300: 1295: 1290: 1285: 1279: 1274: 1269: 1264: 1259: 1254: 1245: 1239: 1234: 1226: 1223: 1219:Public Citizen 1175: 1172: 1160: 1159: 1156: 1153: 1138: 1137:United Kingdom 1135: 1134: 1133: 1130: 1127: 1124: 1121: 1111:European Union 1102: 1099: 1094: 1091: 1078: 1075: 1074: 1073: 1066: 1065: 1058: 1057: 1037:and all other 1019: 1018: 1012: 1011: 1005: 990: 967: 944: 933: 922: 911:dihydrocodeine 904: 878: 877: 863: 860: 847: 844: 843: 842: 832: 811: 797: 767: 740: 737: 736: 735: 724: 717: 706: 686: 683: 682: 681: 678: 671: 670: 667: 664: 648:(CDSCO) Under 638:Main article: 635: 632: 623: 620: 619: 618: 617: 616: 613: 610: 601: 598: 595: 589: 583: 582: 581: 571: 565: 548:Main article: 545: 542: 541: 540: 534: 529: 520: 514: 508: 502: 471: 470:European Union 468: 460: 457: 444: 441: 413: 410: 406:health centers 402: 401: 395: 392: 386: 384:approved drugs 376: 375: 372: 366: 363: 360: 357: 343: 342: 327: 316: 304: 296: 289: 253:, through its 243:Main article: 240: 237: 236: 235: 232: 229: 225: 222: 219: 216: 212: 209: 206: 203: 188: 185: 180:Main article: 177: 174: 168: 165: 159: 158:United Kingdom 156: 133: 130: 109:Pharmacopoeias 73: 70: 26: 24: 14: 13: 10: 9: 6: 4: 3: 2: 2309: 2298: 2295: 2293: 2290: 2288: 2285: 2283: 2280: 2278: 2275: 2274: 2272: 2257: 2254: 2253: 2251: 2247: 2241: 2238: 2236: 2233: 2231: 2228: 2226: 2223: 2221: 2218: 2216: 2213: 2211: 2208: 2206: 2203: 2201: 2198: 2196: 2193: 2191: 2188: 2186: 2183: 2182: 2180: 2176: 2169: 2165: 2161: 2157: 2153: 2149: 2148:United States 2146: 2144: 2141: 2139: 2136: 2135: 2133: 2129: 2125: 2118: 2113: 2111: 2106: 2104: 2099: 2098: 2095: 2091: 2086: 2083: 2081: 2078: 2077: 2073: 2058:on 2014-02-03 2057: 2053: 2047: 2044: 2033:on 2014-10-28 2032: 2028: 2022: 2019: 2006: 2002: 1998: 1991: 1988: 1975: 1971: 1970: 1965: 1959: 1956: 1944: 1940: 1936: 1930: 1927: 1912: 1908: 1907: 1899: 1893: 1890: 1877: 1873: 1867: 1864: 1851: 1847: 1845:0-662-29208-1 1841: 1837: 1836:Health Canada 1833: 1829: 1828: 1821: 1818: 1813: 1807: 1791: 1785: 1779: 1776: 1771: 1765: 1749: 1743: 1737: 1734: 1729: 1723: 1707: 1701: 1695: 1692: 1679: 1673: 1670: 1665: 1659: 1643: 1637: 1631: 1628: 1616: 1612: 1605: 1602: 1597: 1593: 1589: 1583: 1580: 1575: 1569: 1566: 1563: 1558: 1555: 1552: 1547: 1544: 1539: 1532: 1530: 1528: 1526: 1524: 1520: 1515: 1511: 1507: 1503: 1499: 1495: 1491: 1487: 1480: 1478: 1476: 1472: 1467: 1460: 1457: 1452: 1445: 1443: 1441: 1439: 1435: 1430: 1426: 1421: 1416: 1412: 1408: 1404: 1400: 1396: 1389: 1386: 1381: 1377: 1372: 1367: 1363: 1359: 1355: 1351: 1347: 1340: 1338: 1336: 1334: 1330: 1325: 1318: 1315: 1308: 1304: 1301: 1299: 1296: 1294: 1291: 1289: 1286: 1283: 1280: 1278: 1275: 1273: 1270: 1268: 1265: 1263: 1260: 1258: 1255: 1253: 1249: 1246: 1243: 1240: 1238: 1235: 1232: 1229: 1228: 1224: 1222: 1220: 1216: 1212: 1208: 1204: 1200: 1196: 1191: 1189: 1185: 1181: 1174:United States 1173: 1171: 1169: 1165: 1157: 1154: 1151: 1150: 1149: 1146: 1144: 1136: 1131: 1128: 1125: 1122: 1119: 1118: 1117: 1114: 1112: 1108: 1100: 1098: 1092: 1090: 1088: 1084: 1076: 1071: 1070:Unclassifieds 1068: 1067: 1063: 1060: 1059: 1055: 1052: 1051: 1050: 1048: 1044: 1043:flunitrazepam 1040: 1036: 1032: 1028: 1024: 1017: 1014: 1013: 1009: 1008:flunitrazepam 1006: 1003: 999: 995: 991: 988: 984: 983:pentobarbital 980: 976: 972: 968: 965: 961: 957: 953: 949: 945: 942: 938: 934: 931: 927: 926:hydromorphone 923: 920: 916: 915:ethylmorphine 912: 908: 905: 902: 898: 894: 890: 887: 886: 885: 883: 876: 873: 872: 871: 869: 861: 859: 857: 853: 845: 840: 836: 833: 831: 827: 823: 819: 815: 812: 809: 808:flunitrazepam 805: 801: 798: 795: 791: 787: 783: 779: 775: 771: 768: 765: 761: 757: 753: 750: 749: 748: 746: 738: 733: 729: 725: 722: 718: 715: 711: 707: 704: 700: 699: 698: 696: 692: 689:Medicines in 684: 679: 676: 675: 674: 668: 665: 662: 661: 660: 657: 655: 651: 647: 641: 633: 631: 629: 621: 614: 611: 608: 607: 605: 604:Raw materials 602: 599: 596: 593: 590: 587: 584: 579: 575: 572: 569: 566: 563: 560: 559: 557: 556: 555: 551: 543: 538: 535: 533: 530: 528: 524: 521: 518: 515: 512: 509: 506: 503: 500: 497: 496: 495: 493: 489: 484: 482: 478: 469: 467: 466: 458: 456: 454: 450: 442: 440: 438: 434: 429: 427: 423: 419: 418:Health Canada 411: 409: 407: 400: 396: 393: 391: 387: 385: 381: 380: 379: 373: 371: 367: 364: 361: 358: 355: 351: 350: 349: 347: 340: 336: 332: 328: 325: 321: 317: 314: 310: 305: 301: 297: 294: 290: 287: 283: 279: 275: 271: 267: 264: 263: 262: 260: 256: 252: 246: 238: 233: 230: 226: 223: 220: 217: 213: 210: 207: 204: 201: 200: 199: 196: 194: 186: 183: 175: 173: 166: 164: 157: 155: 153: 148: 142: 140: 132:United States 131: 129: 126: 122: 117: 114: 110: 106: 102: 101: 95: 91: 89: 88: 83: 79: 71: 69: 65: 63: 59: 55: 52:, defined as 51: 43: 39: 33: 19: 2225:Soviet Union 2123: 2089: 2060:. Retrieved 2056:the original 2046: 2035:. Retrieved 2031:the original 2021: 2009:. Retrieved 2005:the original 2000: 1990: 1978:. Retrieved 1967: 1958: 1947:. Retrieved 1938: 1929: 1918:. Retrieved 1904: 1892: 1882:18 September 1880:. Retrieved 1866: 1854:. Retrieved 1826: 1820: 1794:. Retrieved 1778: 1752:. Retrieved 1736: 1710:. Retrieved 1694: 1682:. Retrieved 1672: 1646:. Retrieved 1630: 1619:. Retrieved 1604: 1596:the original 1591: 1582: 1568: 1557: 1546: 1537: 1489: 1485: 1465: 1459: 1450: 1402: 1398: 1388: 1353: 1349: 1324:The Atlantic 1323: 1317: 1233:(CIOMS, WHO) 1192: 1177: 1161: 1147: 1140: 1115: 1104: 1096: 1080: 1069: 1061: 1053: 1020: 1015: 998:amphetamines 987:secobarbital 979:methaqualone 901:nicomorphine 897:desomorphine 879: 874: 865: 849: 834: 813: 799: 769: 751: 742: 727: 720: 713: 709: 702: 688: 672: 658: 643: 625: 553: 485: 473: 462: 446: 430: 415: 403: 377: 344: 273: 269: 248: 197: 190: 170: 161: 143: 138: 135: 118: 104: 98: 96: 92: 85: 81: 75: 66: 57: 53: 49: 47: 2282:Drug safety 2230:Switzerland 2205:Netherlands 1796:21 November 1754:20 November 1712:20 November 1684:20 November 1248:Drug policy 1101:Switzerland 1087:Philippines 1077:Philippines 1047:phentermine 964:levorphanol 937:hydrocodone 930:oxymorphone 919:nicocodeine 837:: low-dose 828:, low dose 774:amphetamine 760:lysergamide 300:antibiotics 282:antiseptics 78:Mithridates 2271:Categories 2062:2014-01-30 2037:2022-02-16 1949:2023-03-07 1920:2019-08-19 1648:28 January 1621:2021-11-20 1486:The Lancet 1309:References 1107:Swissmedic 1035:nitrazepam 1023:co-codamol 994:stimulants 946:synthetic 826:nitrazepam 794:tapentadol 721:Obat keras 703:Obat bebas 680:Schedule M 574:Anlage III 370:microbiota 278:Portuguese 2256:Australia 2220:Singapore 2011:4 October 1980:4 October 1093:Sri Lanka 975:temazepam 956:methadone 952:pethidine 941:oxycodone 804:temazepam 790:oxycodone 778:methadone 764:coca leaf 691:Indonesia 685:Indonesia 568:Anlage II 337:(such as 320:sedatives 215:pharmacy. 187:Australia 125:Rofecoxib 2235:Thailand 2215:Portugal 2131:Americas 1974:Archived 1943:Archived 1911:Archived 1876:Archived 1850:Archived 1838:. 2000. 1806:cite web 1764:cite web 1722:cite web 1658:cite web 1615:Archived 1514:13244162 1506:22939670 1380:15327592 1225:See also 1031:diazepam 1027:tramadol 992:various 969:various 960:fentanyl 889:morphine 822:diazepam 786:fentanyl 782:morphine 756:cannabis 562:Anlage I 488:EudraLex 356:reaction 339:morphine 286:vitamins 121:TGN 1412 2249:Oceania 2190:Germany 2178:Eurasia 1420:1429842 1371:1884566 1062:Class F 1054:Class C 1016:Class B 948:opioids 907:codeine 875:Class A 839:codeine 820:, e.g. 739:Ireland 622:Iceland 544:Germany 433:Ontario 335:opioids 72:History 2210:Norway 2143:Canada 2138:Brazil 1856:2 July 1842:  1512:  1504:  1429:389263 1427:  1417:  1378:  1368:  1244:(DESI) 1203:states 1170:(CD). 985:, and 962:, and 893:heroin 862:Norway 841:, etc. 714:apotek 576:BTMG ( 435:, the 412:Canada 239:Brazil 2200:Japan 2195:India 1914:(PDF) 1901:(PDF) 1510:S2CID 1284:(WHO) 1215:RADAR 634:India 459:Egypt 443:China 303:copy. 100:hisba 62:state 54:drugs 2013:2021 1982:2021 1884:2021 1858:2010 1840:ISBN 1812:link 1798:2021 1770:link 1756:2021 1728:link 1714:2021 1686:2021 1664:link 1650:2024 1502:PMID 1425:PMID 1376:PMID 1250:and 1217:and 1081:The 1000:and 939:and 928:and 854:and 274:MIPs 56:and 2160:III 1494:doi 1490:380 1415:PMC 1407:doi 1366:PMC 1358:doi 1221:). 1033:, 1029:, 835:CD5 814:CD4 800:CD3 770:CD2 752:CD1 730:). 431:In 333:), 276:in 272:or 2273:: 2166:- 2164:IV 2162:- 2158:- 2156:II 2154:- 1999:. 1941:. 1937:. 1909:. 1903:. 1848:. 1834:: 1830:. 1808:}} 1804:{{ 1766:}} 1762:{{ 1724:}} 1720:{{ 1660:}} 1656:{{ 1590:. 1522:^ 1508:. 1500:. 1488:. 1474:^ 1437:^ 1423:. 1413:. 1401:. 1397:. 1374:. 1364:. 1354:58 1352:. 1348:. 1332:^ 1190:. 1089:. 1049:. 1045:) 1025:, 996:: 981:, 977:, 973:: 958:, 954:, 950:: 917:, 913:, 899:, 895:, 884:: 858:. 824:, 816:: 806:, 802:: 792:, 788:, 784:, 780:, 776:, 772:: 762:, 758:, 754:: 630:. 455:. 311:, 284:, 2170:) 2168:V 2152:I 2116:e 2109:t 2102:v 2065:. 2040:. 2015:. 1984:. 1952:. 1923:. 1886:. 1860:. 1814:) 1800:. 1772:) 1758:. 1730:) 1716:. 1688:. 1666:) 1652:. 1624:. 1516:. 1496:: 1453:. 1431:. 1409:: 1403:8 1382:. 1360:: 1326:. 1004:; 989:; 966:; 943:; 932:; 921:; 903:; 322:( 84:( 34:. 20:)

Index

Regulation of therapeutic goods in the United States
Prohibition of drugs

Methylphenidate
state
Mithridates
Bald's Leechbook
hisba
Pharmacopoeias
Frederick II of Sicily
TGN 1412
Rofecoxib
Federal, Food, Drug, and Cosmetic Act
Drug Amendments Act of 1962
List of stringent regulatory authorities
Therapeutic Goods Administration
Brazilian Controlled Drugs and Substances Act
Ministry of Health of Brazil
Brazilian Health Regulatory Agency
Food and Drug Administration
Over-the-counter
Portuguese
antiseptics
vitamins
anti-inflammatories
antibiotics
anti-depressants
anti-convulsants
sedatives
benzodiazepines

Text is available under the Creative Commons Attribution-ShareAlike License. Additional terms may apply.

↑