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" â 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:"RESOLUĂĂO 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 StandardâOctober 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 MARĂO 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 ("freiverkÀuflich")
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 â "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 ("BetÀubungsmittel")
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): 781â783.
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): 293â305.
1385:
1356:(3): 317â325.
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:)
Text is available under the Creative Commons Attribution-ShareAlike License. Additional terms may apply.