Regulation of therapeutic goods
Encyclopedia
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.
(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:
are regulated by the Brazilian Health Ministry, through its Sanitary Surveillance Agency (equivalent to USA's FDA). There are 5 main categories:
requires additional regulatory requirements for controlled drugs and drug precursors.
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:
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 Drug
s (CD).
Class A
Narcotics, sedative-hypnotics, and amphetamines in this class require a special prescription form:
Class B
Restricted substances which easily lead to addiction like:
. 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.
There are 5 categories from A to E to cover different types of Delivery category:
A: Single delivery on medical prescription
B: Repeated delivery on medical prescription
C: Prescription free delivery after consultation of a specialist, restricted to pharmacy/chemist
D: Prescription free delivery after consultation of a specialist, restricted to pharmacy, chemist and drugstore
E: Prescription free delivery without consultation in all shops/stores
are regulated by CDSCO - Central Drugs Standard Control Organization Under Ministry of Health and Family Welfare. Headed by Directorate General of Health Services CDSCO regulates the Pharmaceutical Products through DCGI - Drugs Controller General of India at Chair.
Under Retail and Distribution:-
Drugs classified under 5 heads
1. Schedule X drugs – Narcotics
2. Schedule H and L – Injectables, Antibiotics, Antibacterials
3. Schedule C and C1- Biological Products-example Serums and Vaccines
Under Manufacturing Practice
1. Schedule N
List of the equipment for the efficient running of manufacturing wing, Qualified personnel
2. Schedule M
at retail outlets and others by prescription only
.
The possession of some substances is prohibited by scheduling under the Controlled Substances Act
, under the joint jurisdiction of the FDA and the Drug Enforcement Administration
(DEA).
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, 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
Australia
Australia , officially the Commonwealth of Australia, is a country in the Southern Hemisphere comprising the mainland of the Australian continent, the island of Tasmania, and numerous smaller islands in the Indian and Pacific Oceans. It is the world's sixth-largest country by total area...
.
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 AdministrationTherapeutic Goods Administration
The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia . It is a Division of the Australian Department of Health and Ageing established under the Therapeutic Goods Act 1989 ...
(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
Standard for the Uniform Scheduling of Drugs and Poisons
The Standard for the Uniform Scheduling of Medicines and Poisons, abbreviated SUSMP, is a document used in the regulation of drugs and poisons in Australia. It is produced by the National Drugs and Poisons Scheduling Committee , a committee of the Therapeutic Goods Administration...
(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 BrazilBrazil
Brazil , officially the Federative Republic of Brazil , is the largest country in South America. It is the world's fifth largest country, both by geographical area and by population with over 192 million people...
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, antisepticAntisepticAntiseptics are antimicrobial substances that are applied to living tissue/skin to reduce the possibility of infection, sepsis, or putrefaction...
s, vitaminVitaminA vitamin is an organic compound required as a nutrient in tiny amounts by an organism. In other words, an organic chemical compound is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. Thus, the term is conditional both on...
s 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 inflammatories, 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 methylphenidateMethylphenidateMethylphenidate is a psychostimulant drug approved for treatment of attention-deficit hyperactivity disorder, postural orthostatic tachycardia syndrome and narcolepsy. It may also be prescribed for off-label use in treatment-resistant cases of lethargy, depression, neural insult and obesity...
), opioids (such as morphineMorphineMorphine is a potent opiate analgesic medication and is considered to be the prototypical opioid. It was first isolated in 1804 by Friedrich Sertürner, first distributed by same in 1817, and first commercially sold by Merck in 1827, which at the time was a single small chemists' shop. It was more...
and oxycodone) and other strong habit-forming controlled medicines.
Canada
In Canada, regulation of therapeutic goods are governed by the Food and Drug Act and associated regulations. In addition, the Controlled Drugs and Substances ActControlled Drugs and Substances Act
The Controlled Drugs and Substances Act is Canada's federal drug control statute. Passed in 1996 by the Chrétien government, it repeals the Narcotic Control Act and Parts III and IV of the Food and Drug Act and establishes eight Schedules of controlled substances and two Classes of precursors...
requires additional regulatory requirements for controlled drugs and drug precursors.
China
The regulation of drugs in China is governed by the State Food and Drug Administration.United Kingdom
Medicines in the United KingdomUnited Kingdom
The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...
are regulated by the Medicines and Healthcare products Regulatory Agency
Medicines and Healthcare products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe....
(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
Misuse of Drugs Act 1971
The Misuse of Drugs Act 1971 is an Act of Parliament which represents UK action in line with treaty commitments under the Single Convention on Narcotic Drugs, the Convention on Psychotropic Substances, and the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic...
and the Misuse of Drugs Regulations 2001; and are commonly known as Controlled Drug
Controlled Drug
The United Kingdom Misuse of Drugs Act 1971 aimed to control the possession and supply of numerous listed drugs and drug-like substances as a controlled substance. The act allowed and regulated the use of some Controlled Drugs by various classes of persons The United Kingdom Misuse of Drugs Act...
s (CD).
Norway
Medicines in Norway are divided into five groups:Class A
Narcotics, sedative-hypnotics, and amphetamines in this class require a special prescription form:
- morphineMorphineMorphine is a potent opiate analgesic medication and is considered to be the prototypical opioid. It was first isolated in 1804 by Friedrich Sertürner, first distributed by same in 1817, and first commercially sold by Merck in 1827, which at the time was a single small chemists' shop. It was more...
and its immediate family, heroin, desomorphineDesomorphineDesomorphine is an opiate analogue invented in 1932 in the United States that is a derivative of morphine, where the 6-hydroxyl group has been removed and the 7,8 double bond has been saturated. It has sedative and analgesic effects, and is around 8-10 times more potent than morphine...
, nicomorphineNicomorphineNicomorphine is the 3,6-dinicotinate ester of morphine. It is a strong opioid agonist analgesic two to three times as potent as morphine with a side effect profile similar to that of dihydromorphine, morphine, and diamorphine. Nicomorphine was patented as Vilan by Lannacher Heilmittel Ges. m.b.H...
; - codeineCodeineCodeine or 3-methylmorphine is an opiate used for its analgesic, antitussive, and antidiarrheal properties...
and its immediate family, dihydrocodeineDihydrocodeineDihydrocodeine, also called DHC, Drocode, Paracodeine and Parzone and known by the brand names of Synalgos DC, Panlor DC, Panlor SS, Contugesic, New Bron Solution-ACE, Huscode, Drocode, Paracodin, Codidol, Didor Continus, Dicogesic, Codhydrine, Dekacodin, DH-Codeine,...
, ethylmorphineEthylmorphineEthylmorphine is an opiate narcotic analgesic .Ethylmorphine was invented in Germany at Merck in 1884 and was used as a weaker alternative to heroin for all indications. Chemically, ethylmorphine is a morphine molecule with a -25 group substituted for the aromatic 3- group...
, nicocodeineNicocodeineNicocodeine is an opiate derivative, closely related to dihydrocodeine and the codeine analogue of nicomorphine developed as a cough suppressant and analgesic. It is not commonly used in most countries, but has activity similar to other opiates. Nicocodeine and nicomorphine were introduced in the...
; - morphine relatives: hydromorphoneHydromorphoneHydromorphone, a more common synonym for dihydromorphinone, commonly a hydrochloride is a very potent centrally-acting analgesic drug of the opioid class. It is a derivative of morphine, to be specific, a hydrogenated ketone thereof and, therefore, a semi-synthetic drug...
and oxymorphoneOxymorphoneOxymorphone or 14-Hydroxydihydromorphinone is a powerful semi-synthetic opioid analgesic first developed in Germany circa 1914, patented in the USA by Endo Pharmaceuticals in 1955 and introduced to the United States market in January 1959 and other countries around the same time...
; - codeine relatives: hydrocodoneHydrocodoneHydrocodone or dihydrocodeinone is a semi-synthetic opioid derived from either of two naturally occurring opiates: codeine and thebaine. It is an orally active narcotic analgesic and antitussive...
and oxycodoneOxycodoneOxycodone is an opioid analgesic medication synthesized from opium-derived thebaine. It was developed in 1916 in Germany, as one of several new semi-synthetic opioids in an attempt to improve on the existing opioids: morphine, diacetylmorphine , and codeine.Oxycodone oral medications are generally...
; - synthetic opioids: pethidinePethidinePethidine or meperidine Pethidine (INN) or meperidine (USAN) Pethidine (INN) or meperidine (USAN) (commonly referred to as Demerol but also referred to as: isonipecaine; lidol; pethanol; piridosal; Algil; Alodan; Centralgin; Dispadol; Dolantin; Mialgin (in Indonesia); Petidin Dolargan (in Poland);...
, methadoneMethadoneMethadone is a synthetic opioid, used medically as an analgesic and a maintenance anti-addictive for use in patients with opioid dependency. It was developed in Germany in 1937...
, fentanyl, and levorphanolLevorphanolLevorphanol is an opioid medication used to treat severe pain. It is the levorotatory stereoisomer of the synthetic morphinan and a pure opioid agonist, first described in Germany in 1948 as an orally active morphine-like analgesic...
; - various sedative-hypnoticHypnoticHypnotic drugs are a class of psychoactives whose primary function is to induce sleep and to be used in the treatment of insomnia and in surgical anesthesia...
s: temazepamTemazepamTemazepam is an intermediate-acting 3-hydroxy benzodiazepine. It is mostly prescribed for the short-term treatment of sleeplessness in patients who have difficulty maintaining sleep...
, methaqualoneMethaqualoneMethaqualone is a sedative-hypnotic drug that is similar in effect to barbiturates, a general central nervous system depressant. The sedative-hypnotic activity was first noted by Indian researchers in the 1950s and in 1962 methaqualone itself was patented in the US by Wallace and Tiernan...
, pentobarbitalPentobarbitalPentobarbital is a short-acting barbiturate that was first synthesized in 1928. Pentobarbital is available as both a free acid and a sodium salt, the former of which is only slightly soluble in water and ethanol....
, and secobarbitalSecobarbitalSecobarbital sodium is a barbiturate derivative drug that was first synthesized in 1928 in Germany. It possesses anaesthetic, anticonvulsant, sedative and hypnotic properties...
; - various stimulantStimulantStimulants are psychoactive drugs which induce temporary improvements in either mental or physical function or both. Examples of these kinds of effects may include enhanced alertness, wakefulness, and locomotion, among others...
s: amphetamineAmphetamineAmphetamine or amfetamine is a psychostimulant drug of the phenethylamine class which produces increased wakefulness and focus in association with decreased fatigue and appetite.Brand names of medications that contain, or metabolize into, amphetamine include Adderall, Dexedrine, Dextrostat,...
s and methylphenidateMethylphenidateMethylphenidate is a psychostimulant drug approved for treatment of attention-deficit hyperactivity disorder, postural orthostatic tachycardia syndrome and narcolepsy. It may also be prescribed for off-label use in treatment-resistant cases of lethargy, depression, neural insult and obesity...
; - flunitrazepamFlunitrazepamFlunitrazepam is marketed as a potent hypnotic, sedative, anticonvulsant, anxiolytic, amnestic, and skeletal muscle relaxant drug most commonly known as Rohypnol...
(moved from class B)
Class B
Restricted substances which easily lead to addiction like:
- co-codamolCo-codamolCo-codamol is a non-proprietary name used to denote a compound analgesic, a combination of codeine phosphate and paracetamol . Co-codamol Co-codamol (BAN) is a non-proprietary name used to denote a compound analgesic, a combination of codeine phosphate and paracetamol (acetaminophen). Co-codamol...
, diazepamDiazepamDiazepam , first marketed as Valium by Hoffmann-La Roche is a benzodiazepine drug. Diazepam is also marketed in Australia as Antenex. It is commonly used for treating anxiety, insomnia, seizures including status epilepticus, muscle spasms , restless legs syndrome, alcohol withdrawal,...
, nitrazepamNitrazepamNitrazepam is a type of benzodiazepine drug and is marketed in English-speaking countries under the following brand names: Alodorm, Arem, Insoma, Mogadon, Nitrados, Nitrazadon, Ormodon, Paxadorm, Remnos, and Somnite...
, and all other benzodiazepineBenzodiazepineA benzodiazepine is a psychoactive drug whose core chemical structure is the fusion of a benzene ring and a diazepine ring...
s (with the exception of temazepam and flunitrazepamFlunitrazepamFlunitrazepam is marketed as a potent hypnotic, sedative, anticonvulsant, anxiolytic, amnestic, and skeletal muscle relaxant drug most commonly known as Rohypnol...
), phenterminePhenterminePhentermine, a contraction of "phenyl-tertiary-butylamine", is a psychostimulant drug of the phenethylamine class, chemically related to amphetamine. It is used medically as an appetite suppressant....
;
- 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
Iceland
Medicines in Iceland are regulated by the Icelandic Medicines Control Agency http://www.imca.is/.Switzerland
Medicines in Switzerland are regulated by SwissMedicSwissmedic
Swissmedic, the Swiss Agency for Therapeutic Products, is the Swiss surveillance authority for medicines and medical devices, registered in Berne. It started operations on 1 January 2002 as successor of Interkantonale Kontrollstelle für Heilmittel , which was itself the successor of Schweizerische...
. The country is not part of the European Union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
, and is regarded by many as one of the easiest places to conduct clinical trials on new drug compounds.
There are 5 categories from A to E to cover different types of Delivery category:
A: Single delivery on medical prescription
B: Repeated delivery on medical prescription
C: Prescription free delivery after consultation of a specialist, restricted to pharmacy/chemist
D: Prescription free delivery after consultation of a specialist, restricted to pharmacy, chemist and drugstore
E: Prescription free delivery without consultation in all shops/stores
India
Medicines in IndiaIndia
India , officially the Republic of India , is a country in South Asia. It is the seventh-largest country by geographical area, the second-most populous country with over 1.2 billion people, and the most populous democracy in the world...
are regulated by CDSCO - Central Drugs Standard Control Organization Under Ministry of Health and Family Welfare. Headed by Directorate General of Health Services CDSCO regulates the Pharmaceutical Products through DCGI - Drugs Controller General of India at Chair.
Under Retail and Distribution:-
Drugs classified under 5 heads
1. Schedule X drugs – Narcotics
2. Schedule H and L – Injectables, Antibiotics, Antibacterials
3. Schedule C and C1- Biological Products-example Serums and Vaccines
Under Manufacturing Practice
1. Schedule N
List of the equipment for the efficient running of manufacturing wing, Qualified personnel
2. Schedule M
United States
Therapeutic goods in the United States are regulated by the U.S. Food and Drug Administration (FDA), which makes some drugs available over the counterOver-the-counter drug
Over-the-counter drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription...
at retail outlets and others by prescription only
Prescription drug
A prescription medication is a licensed medicine that is regulated by legislation to require a medical prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription...
.
The possession of some substances is prohibited by scheduling under the Controlled Substances Act
Controlled Substances Act
The Controlled Substances Act was enacted into law by the Congress of the United States as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. The CSA is the federal U.S. drug policy under which the manufacture, importation, possession, use and distribution of certain...
, under the joint jurisdiction of the FDA and the Drug Enforcement Administration
Drug Enforcement Administration
The Drug Enforcement Administration is a federal law enforcement agency under the United States Department of Justice, tasked with combating drug smuggling and use within the United States...
(DEA).
See also
- Council for International Organizations of Medical SciencesCouncil for International Organizations of Medical SciencesThe Council for International Organizations of Medical Sciences is an international, nongovernmental, not-for-profit organization established jointly by WHO and UNESCO in 1949....
(CIOMS, WHO) - Counterfeit drug
- Drug Efficacy Study ImplementationDrug Efficacy Study ImplementationDrug Efficacy Study Implementation was a program begun by the Food and Drug Administration in the 1960s after the requirement that all drugs be efficacious as well as safe. The DESI program was intended to classify all pre-1962 drugs that were already on the market as either effective,...
(DESI) - Drug prohibition lawDrug prohibition lawDrug prohibition law is prohibition-based law by which governments prohibit, except under licence, the production, supply, and possession of many, but not all, substances which are recognised as drugs, and which corresponds to international treaty commitments in the Single Convention on Narcotic...
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
- Inverse benefit lawInverse benefit lawThe Inverse Benefit Law states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively a drug is marketed...
- Over-the-counter drugOver-the-counter drugOver-the-counter drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription...
- Prescription drugPrescription drugA prescription medication is a licensed medicine that is regulated by legislation to require a medical prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription...
- Uppsala Monitoring CentreUppsala Monitoring CentreThe Uppsala Monitoring Centre , located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring...
(WHO) - Validation (drug manufacture)Validation (drug manufacture)Validation in the pharmaceutical, medical device, food, blood establishments, tissue establishments, and clinical trials industries is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the...
- World Health OrganizationWorld Health OrganizationThe World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...
European Union
- EudraLexEudraLexEudraLex is the collection of rules and regulations governing medicinal products in the European Union.-Volumes:EudraLex consists of 10 volumes:*Concerning Medicinal Products for Human use:**Volume 1 - Pharmaceutical Legislation....
, the collection of rules and regulations governing medicinal products in the European Union - Directive 65/65/EEC1Directive 65/65/EEC1Directive 65/65/EEC1 was the first European pharmaceutical directive. -Intention:The directive was a reaction to the Thalidomide tragedy in the early 1960s, when thousands of babies were born with deformities as a result of their mothers taking the drug during pregnancy...
, requires prior approval for marketing of proprietary medicinal products - Directive 75/318/EECDirective 75/318/EECDirective 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products...
, clarifies requirements of 65/65/EEC1 and requires member states to enforce them - Directive 75/319/EECDirective 75/319/EECDirective 75/319/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products...
, requires marketing authorization requests to be drawn up only by qualified experts - Directive 93/41/EECDirective 93/41/EECCouncil of the European Communities Directive 93/41/EEC of 14 June 1993 repealed Directive 87/22/EEC on the approximation of national measures relating to the marketing of high-technology medicinal products, as this directive had been superseded by Council Regulation No 2309/93 of 22 July 1993...
, establishes the European Agency for the Evaluation of Medicinal Products - European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
- Directive 2001/20/ECDirective 2001/20/ECThe Clinical Trials Directive is a European Union directive that aimed at...
, defines rules for the conduct of clinical trials - Directive 2001/83/ECDirective 2001/83/ECDirective 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use...
- Directive 2005/28/ECDirective 2005/28/ECThe Good Clinical Practice Directive lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.The directive...
, defines Good Clinical Practice for design and conduct of clinical trials