National Policy on Traditional Medicine and Regulation of Herbal Medicines - Report of a WHO Global Survey
(2005; 168 pages) Ver el documento en el formato PDF
Índice de contenido
Ver el documentoAcknowledgements
Ver el documentoExecutive summary
Ver el documentoAcronyms, abbreviations and definitions
Ver el documentoWHO Regions
Abrir esta carpeta y ver su contenido1. Introduction
Abrir esta carpeta y ver su contenido2. National policy on traditional medicine and complementary/alternative medicine
Abrir esta carpeta y ver su contenido3. The regulatory situation of herbal medicines
Abrir esta carpeta y ver su contenido4. Member States, WHO and herbal medicines
Cerrar esta carpeta5. Country summaries
Ver el documento5.1 WHO African Region
Ver el documento5.2 WHO Region of the Americas
Ver el documento5.3 WHO Eastern Mediterranean Region
Ver el documento5.4 WHO European Region
Ver el documento5.5 WHO South-East Asia Region
Ver el documento5.6 WHO Western Pacific Region
Ver el documentoReferences
Ver el documentoAnnex 1. Text of survey instrument
 

5.2 WHO Region of the Americas

Countries that responded to the survey: Region of the Americas

Eighteen of the 35 countries of the WHO Region of the Americas responded to the Global Survey. Table 5 summarizes the development of national policy and regulation of TM/CAM and herbal medicines in the Region of the Americas, with comparative figures for all the responding countries and the global percentages. The figures and percentages represent those countries responding positively to the questions. The survey response figures represent all of the responding countries, either in the region or globally as indicated.

Table 5. Region of the Americas: positive responses

 

Member States in the Americas Region responding positively with the following

Regional survey % that responded positively
(18)

Global survey % that responded positively
(141)

National policy on TM/CAM

3

17%

32%

Law or regulation on TM/CAM

6

33%

38%

National programme on TM/CAM

4

22%

28%

National office for TM/CAM

8

44%

53%

Expert committee on TM/CAM

9

50%

43%

National research institute on TM, CAM or herbal medicines

7

39%

41%

Law or regulation on herbal medicines

13

72%

65%

Registration of herbal medicines

13

72%

61%

In the WHO Region of the Americas, there are considerable differences in the kinds of policies and regulations that have been developed. Many countries have regulation and registration systems for herbal medicines, yet the number of countries developing similar laws, regulations or national policies on TM/CAM is relatively small. However, the number of countries having expert committees, national research institutes and national offices is much higher, which may mean that such policies and regulations are being developed, or will be in the future.

Antigua and Barbuda

In Antigua and Barbuda, none of the following have been issued or established for TM/CAM: national policy, laws and regulations, a national programme, a national office, expert committee or national research institutes. None of these are in development.

Antigua and Barbuda does not regulate herbal medicines, and herbal medicines have no regulatory status. No claims can legally be made about herbal medicines. There is neither a national pharmacopoeia nor national monographs, and no other materials are used in their place.

There are no manufacturing or safety assessment regulatory requirements, nor is a registration system in place. Herbal medicines are not included on an essential drug list. No post marketing surveillance system exists or is planned. In Antigua and Barbuda, herbal medicines are sold in pharmacies as over the counter medicines, in special outlets and without restriction.

Argentina

The national policy on TM/CAM in the Argentine Republic is currently in development. In 1998, Resolution 144/98 established laws and regulations on TM/CAM, specifically on phytotherapeutic medicines and vegetable drugs. Under this same resolution, a national programme was established. The national office on TM/CAM is administered by the Ministry of Health, and is called the Committee on Harmonization of Vegetable Drugs; it was founded in 1992. An expert committee on TM/CAM was created in 1999. No national research institutes on TM/CAM currently exist.

Herbal regulation in Argentina was introduced in 1998 in Resolution 144/98. It established regulations that were partly the same as, but separate from, those used for conventional pharmaceuticals. In Argentina, herbal medicines are regulated as prescription medicines, over the counter medicines and dietary supplements. By law, medical claims may be made about herbal medicines.

The national pharmacopoeia is called the Farmacopea nacional argentina (1965); in addition, other pharmacopoeias used include the United States pharmacopoeia, European pharmacopoeia and British pharmacopoeia. The information in these pharmacopoeias is legally binding. National monographs are in preparation; however, the following materials are currently used and are legally binding: United States pharmacopoeia, European pharmacopoeia, British pharmacopoeia, European Scientific Cooperative on Phytotherapy (ESCOP) monographs and the WHO monographs.

The relevant regulatory requirements for manufacturing include adherence to information in pharmacopoeias and monographs and special GMP rules. The safety assessment requirements include traditional use without demonstrated harmful effects, reference to documented scientific research on similar products, toxicological studies when traditional use cannot be demonstrated and submission of a full toxicological and pharmacological dossier. Compliance with these requirements is ensured by the requirement for a formal registration process submitted to the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (National Administration of Drugs, Foods and Medical Devices - ANMAT), which ensures full compliance with the manufacturing and safety assessment requirements.

There is a registration system for herbal medicines, but the number of registered medicines is not currently available. No herbal medicines are included on an essential drug list. Argentina has a post marketing surveillance system that includes a national system to monitor adverse effects of all medicines, including herbal medicines, which was established in 1993. In Argentina, herbal medicines are sold in pharmacies as prescription and over the counter medicines, in special outlets and by licensed practitioners.

Bolivia

In the Republic of Bolivia, there is not currently a national policy on TM/CAM, nor is any policy being developed. There are laws and regulations on TM/CAM that were issued in 1987. There is no national programme on TM/CAM in existence or in preparation. A national office is being planned. No committee of experts exists. Research on herbal medicines is undertaken at the Instituto de Investigaciones Farmacobioquímicas de la Facultad de Farmacia y Bioquímica de la Universidad Mayor de San Andrés (Institute of Pharmacobiochemical Research, Faculty of Pharmacy and Biochemistry, UMSA) and the Cochabamba Laboratory, acting as national research institutes.

Herbal regulation in Bolivia was introduced in 1996 in Law No. 1737; this legislation is partly the same as that which regulates conventional pharmaceuticals. Herbal medicines are regulated in Bolivia as over the counter medicines and in their own independent regulatory category. Claims that may be made by law are limited to medical claims. There is no national pharmacopoeia, nor is one in preparation; however, the British herbal compendium (1992) is used in its place. No information is available on national monographs or other monographs used.

Special GMP rules apply to herbal medicines, yet there is no mechanism for ensuring their implementation. Safety assessment requirements are limited to traditional use without demonstrated harmful effects; again, there is no existing control mechanism. There are currently 52 registered herbal medicines. No herbal medicines are included on the essential drug list. A post marketing surveillance system is being planned. In Bolivia, herbal medicines are sold in pharmacies as over the counter medicines and in special outlets with no restrictions.

Brazil

In the Federative Republic of Brazil, there is currently no national policy on TM/CAM, but the Ministry of Health is elaborating the Natural Medicine and Complementary Practices National Policy, which includes phytotherapy, acupuncture, homeopathy and anthroposophic medicine. A standardization proposal for the use of medicinal plants and phytotherapeutic medicines in the Sistema Único de Salud (Unified Health System - SUS) is being drafted. Laws and regulations and a national programme are in preparation. There is no national office or expert committee, nor are there national research institutes.

Regulation of herbal medicine has existed in Brazil since 1967, and the fourth version of the regulations, RDC 48/2004, was put in place in 2004. It is partly the same as the legislation on conventional pharmaceuticals. Herbal medicines are regulated in the following categories: herbal drugs (both prescription medicines and over the counter medicines), functional foods, probiotics, bioactive substances and cosmetics. Medical claims can only be made if the product is registered as a herbal drug. The national pharmacopoeia is the Farmacopéia brasileira (4th ed., 1988); the information it contains is legally binding. The national pharmacopoeia also contains the national monographs.

The regulatory requirements for manufacturing include adherence to the information contained in pharmacopoeias and monographs, and the same rules of good manufacturing practice as for conventional pharmaceuticals, as well as special rules. These requirements are ensured through certification of GMP for the production and pharmaceutical areas. Safety assessment requirements include the same requirements as for conventional pharmaceuticals and special requirements of traditional use without demonstrated harmful effects; again, there is no existing control mechanism, but reference is made to documented scientific research on similar products. The implementation of these requirements is ensured through annual inspections.

There are more than 1000 herbal medicines registered in Brazil; none is included on the national essential drug list; however, a list of phytotherapeutic medicines is currently being prepared for inclusion. There is a post marketing surveillance system that includes adverse effect monitoring, established in 2001. Herbal medicines in Brazil are sold in pharmacies as prescription and over the counter medicines. In 2001, the total sales of herbal medicines reached an estimated US$ 400 million.

Canada

Canada has no national policy, laws or regulations or national programme on TM/CAM. No national laws or regulations apply to any health disciplines, as power in these areas lies entirely with the provinces and territories. A national office exists, the Natural Health Products Directorate of the Health Product and Food Branch. It was established in 1999, and is administered by the Ministry of Health. The office also serves as the expert committee and national research institute.

Regulation of herbal medicines was introduced in Canada in 2003 in separate laws within the Food and Drugs Act. Herbal medicines are regulated as over the counter medicines, self medication, dietary supplements and as natural health products. By law, medical, health, nutrient content and structure/function claims may be made about herbal medicines.

No national pharmacopoeia exists. National monographs are in development. In place of a national pharmacopoeia and national monographs, the following materials are used: Compendium of pharmaceuticals and specialties, Canadian drug reference for health professionals, Compendium of nonprescription products (CNP), United States pharmacopoeia, Herbal medicines, Expanded Commission E monographs, ESCOP monographs, WHO monographs, Pharmacopoeia of the People’s Republic of China, PDR for herbal medicines, British herbal compendium and British herbal pharmacopoeia.

Special GMP rules are required for manufacturing of herbal medicines; these are enforced by submitting to inspection to ensure the granting of a site licence to manufacturers, importers and labellers. To market a herbal product, the manufacturer, importer or labeller must have both a site licence and a product licence. Special requirements for safety assessment include special requirements of traditional use without demonstrated harmful effects and reference to documented scientific research on similar products. Requirements for safety assessment are enforced by the need for a product licence that is conditional on providing satisfactory evidence of compliance with the safety requirements laid down in the regulations.

Under the current system of herbal registration, over 10 000 herbal medicines were registered. A new system was due to come into effect during 2004. No herbal medicines are included on an essential drug list. A post marketing surveillance system that includes monitoring of adverse effects of herbal medicines was established in 1965 and is the same as for conventional pharmaceuticals.

In Canada, herbal medicines are sold in pharmacies as over the counter medicines, in special outlets, by licensed and unlicensed practitioners and in multi level marketing.

Annual market sales based on a market survey of herbal medicines for Canada in 1999 was US$ 380 million, in 2000 US$ 400 million and in 2001 US$ 400 million. In 1999, sales of herbs and vitamins were estimated at 937 million Canadian dollars (US$ 715 million).

Chile

A national policy on TM/CAM is in development in the Republic of Chile, as are laws and regulations. In 1992, a national programme was established, and in the same year the national office, Unidad de Medicina Tradicional y Otras Practicas Médicas Alternativas (Unit for Traditional Medicine and Other Alternative Medical Practices) was established within the Ministry of Health. No national research institutes on TM/CAM or herbal medicines have been established.

In 2002, Chile began regulation of herbal medicines, with a separate, specialized law. Herbal medicines are regulated as over the counter medicines, as dietary supplements and as an independent regulatory category. By law, medical and health claims may be made about herbal medicines. In place of an outdated national pharmacopoeia, alternatives are used, including the following: International pharmacopoeia, United States pharmacopoeia, British pharmacopoeia, German pharmacopoeia and German homeopathic pharmacopoeia. National monographs are in production.

Regulatory requirements for manufacturing include observation of information in pharmacopoeias and monographs and special GMP rules for herbal medicines. These requirements are guaranteed through authorization and control of packaging establishments. Special rules for safety assessment include traditional use without demonstrated harmful effects and reference to documented scientific research on similar products. Implementation of these requirements is ensured by an official listing system and hygienic controls placed on packaging establishments and on the medicines themselves.

There is no registration system, nor are herbal medicines included on an essential drug list. There is a national post marketing surveillance system that includes adverse effect monitoring for herbal medicines. In Chile, herbal medicines are sold in pharmacies as over the counter medicines and in special outlets.

Colombia

In the Republic of Colombia, a national policy on TM/CAM neither exists nor is pending. Laws and regulations on TM/CAM were first issued in 1964 in Decree 1950, and were updated and expanded in 1995, 1997, 1998 and 2001. No national programme has been issued, nor has a national office been established, and neither is planned. An expert committee on TM/CAM was established in 1976. The Instituto Humboldt, founded in 1900, serves as a national research institute in CAM.

Herbal medicine is regulated in Colombia by means of Decree 677 of 1995 and Decree 337 of 1998. The regulations established are partly the same as those for conventional pharmaceuticals, while some are separate for herbal medicines. Herbal medicines are regulated as over the counter medicines and as an independent regulatory category. Claims that are made about herbal medicines include medical, health and structure/function claims, but none are recognized by law.

No national pharmacopoeia exists, nor is one planned; in lieu of this, the United States pharmacopoeia, Codex francés and British herbal pharmacopoeia are used. The information is considered legally binding. National monographs exist, but they are not legally binding.

Regulatory requirements for manufacturing include adherence to the information contained in pharmacopoeias and monographs, the same rules of GMP as for conventional pharmaceuticals, and special rules. No information on control mechanisms is available. Safety assessment requirements include traditional use without demonstrated harmful effects, reference to documented scientific research on similar products and clinical studies. Compliance with these requirements is ensured by a health registry.

There is a registration system for herbal medicines; the number of registered medicines is not available. Herbal medicines are not included on the essential drug list. No system of post marketing surveillance exists or is being planned. Herbal medicines in Colombia are sold in pharmacies as over the counter medicines and special outlets without restriction.

Costa Rica

In the Republic of Costa Rica, a national policy on TM/CAM and a national programme have not been issued and are not currently being developed. Laws and regulations on TM/CAM currently exist. A national office solely for TM/CAM does not exist; however, the Ministry of Health includes units responsible for the regulation of TM/CAM, including an expert committee that controls and registers products. National institutes of herbal medicines exist at the Escuela de las Ciencias de la Tierra y el Mar (School of Earth and Marine Sciences, established 1980) and Centro de Investigaciones de Productos Naturales (Centre for Research into Natural Products, established 1988).

In Costa Rica, regulation of herbal medicines involves separate regulations that are partly the same as those for conventional pharmaceuticals and cover the registration, importation, marketing and advertising of herbal medicines. They are not classified in any regulatory category. By law, statements may be made regarding medical, health, nutrient content and structure/function claims; however, medical claims must be supported by the scientific literature.

No national pharmacopoeia exists. None is planned, and no others are used instead. No national monographs exist, but instead the following, among others, are used, although they are not legally binding: Complete German Commission E monographs and WHO monographs on selected medicinal plants.

The same GMP rules are required for the manufacture of herbal medicines as are used for conventional pharmaceuticals; compliance with these is guaranteed by means of routine inspections and an initial inspection for permission to begin manufacturing. Special GMP rules are currently being developed especially for herbal medicines. The same requirements for safety assessment apply to herbal medicines as to conventional pharmaceuticals; implementation is ensured by laboratory analysis and user reports and complaints.

A total of 359 herbal medicines are registered; there is no national essential drug list. There is a national post marketing surveillance system that includes herbal medicines. In Costa Rica, herbal medicines are sold in pharmacies as over the counter medicines and in special outlets without restriction.

Dominica

A national policy on TM/CAM is being developed in the Commonwealth of Dominica, as is a national programme. There are, however, currently no plans to develop laws or regulations. No national office exists, and information is unavailable about any plans to develop one. An expert committee has been created. No national research institutes currently exist.

Herbal medicines are not regulated in Dominica; however, they are sold with health claims. In place of a national pharmacopoeia, the British pharmacopoeia is used and is legally binding. No national monographs exist.

There are no manufacturing requirements and safety requirements are limited to traditional use without demonstrated harmful effects. There is no quality control mechanism for this requirement. There is no registration system, nor are herbal medicines included on the essential drug list. A post marketing surveillance system is planned. In Dominica, herbal medicines are sold as over the counter medicines and in special outlets without restriction.

Dominican Republic

In the Dominican Republic, national policy on TM/CAM is in development; in 2001, laws and regulations were adopted. No national programme has been issued. In 1993, the national office on TM/CAM was established under the Ministry of Health. No expert committee currently exists. There are no national research programmes.

Herbal medicine regulation was introduced in 2001; the regulation is partly the same as for conventional pharmaceuticals. Herbal medicines are regulated as over the counter medicines, self medication and dietary supplements. By law, medical, health, nutrient content and structure/function claims may be made about herbal medicines. No national pharmacopoeia or monographs exist and none are being developed.

The same GMP requirements apply to herbal medicines as to conventional pharmaceuticals. No information is available on the control mechanism for these manufacturing requirements. There are no safety assessment regulatory requirements. The registrations system includes 3 000 herbal medicines; there are no herbal medicines on the essential drug list. A post marketing surveillance system is being planned. In the Dominican Republic, herbal medicines are sold as over the counter medicines and in special outlets without restriction.

Ecuador

In the Republic of Ecuador, national policy on TM/CAM is currently at the development stage; however, laws and regulations were issued in 1998. A national programme is currently being planned, as is a national office. No expert committee exists, nor do any national research institutes.

Ecuador does not currently regulate herbal medicines; the regulatory status given to herbal medicines includes prescription and over the counter medicines, self medication, dietary supplements, health foods and cosmetics. Medical and health claims may be made by law. A national pharmacopoeia is being developed; no information is available on national monographs.

Likewise, there is no information on manufacturing requirements for herbal medicines; there are no safety requirements. Herbal medicines are not registered or included on an essential drug list. No post marketing surveillance system exists. In Ecuador, herbal medicines are sold in special outlets without restriction.

El Salvador

The Republic of El Salvador has no national policy, laws, regulations, national programme, national office, expert committee or national research institute for TM/CAM. None of these is currently being developed.

El Salvador established regulation of herbal medicines in 1988 through Decree No. 55; this is the same law that regulates conventional pharmaceuticals. Herbal medicines are regulated as prescription and over the counter medicines. Medical, health and nutrient content claims are made about herbal medicines. There is no national pharmacopoeia, nor is one in development. Instead, the following pharmaceuticals are used: German pharmacopoeia, Pharmacopoeia argentina, British pharmacopoeia, United States pharmacopoeia, Spanish pharmacopoeia, European pharmacopoeia, Swiss pharmacopoeia, International pharmacopoeia, Japanese pharmacopoeia and Mexican pharmacopoeia. The information contained in these pharmacopoeias is legally binding. No national monographs have been, or are being, developed; no others are used in their place.

Manufacturing regulatory requirements consist of special GMP rules for herbal medicines; compliance with these rules is ensured through inspection and a manufacturing licensing system. Safety assessment regulatory requirements consist of special requirements including traditional use without demonstrated harmful effects and reference to scientific research on similar products. No control mechanism exists to ensure compliance with these safety requirements.

There is a registration system, and 51 herbal medicines are registered. No herbal medicines are included on the national essential drug list. No post marketing surveillance system exists; however, one is being planned. In El Salvador, herbal medicines are sold in pharmacies as prescription and over the counter medicines, and in special outlets.

Guatemala

The national policy of the Republic of Guatemala on TM/CAM was established in 2000 in the Politicas del Plan Nacional de Salud, 2000 2004 (Policies of the National Health Plan, 2000 2004). Laws and regulations are currently being developed. The national programme and national office were established in 2001; the office is called the Programa Nacional de Medicina Popular Tradicional (National Programme of Popular Traditional Medicine). The Ministry of Health and Social Assistance administers the office. There is no expert committee. National research institutes on traditional medicine are part of the Universidad de San Carlos de Guatemala, including the Centro de Estudios Folklóricos (Centre for Folklore Studies, established in 1981), the Faculty of Chemical Sciences and Pharmacy and the Faculty of Agronomy.

Guatemala has issued a number of regulations related to herbal medicines, which are partly the same as those for conventional pharmaceuticals. Herbal medicines are regulated as prescription and over the counter medicines. By law, medical and structure/function claims may be made. A national pharmacopoeia and national monographs are being developed; the WHO monographs are used in place of the national ones.

The manufacturing regulatory requirements are the same GMP rules applied to conventional pharmaceuticals; implementation is enforced through annual self inspections. Special safety requirements include traditional use without demonstrated harmful effects and reference to documented scientific research on similar products. There are control mechanisms for these safety requirements, but no specific information is available.

The registration system is currently under revision, so the number of registered herbal medicines is not known. There are no herbal medicines on the essential drug list. There is no post marketing surveillance system, nor is one currently being planned. In Guatemala, herbal medicines are sold in pharmacies as prescription and over the counter medicines.

Jamaica

In Jamaica, a national policy, laws and regulations and a national programme are being developed. The national office was established in 2000 as part of the Ministry of Heath. An expert committee also exists, as does a national research institute on herbal medicines.

The policy to regulate herbal medicines in Jamaica is currently being developed by amending the previous policy to incorporate herbal medicines. Herbal medicines are classified as prescription and over the counter medicines, dietary supplements, health foods, functional foods and homeopathic products. Claims may be made about herbal medicines; for medical claims, a product must be registered, while for health, nutrient content and structure/function claims, product registration may be required, depending on the nature of the claims and the product components.

In place of a national pharmacopoeia, the British herbal pharmacopoeia (1983) is used. In place of national monographs, the Complete German Commission E monographs and Herbal drugs and phytochemicals (1994, Wichtl and Grainger, eds.) are used. The latter contains 181 monographs. Neither is considered legally binding.

The same manufacturing requirements apply to herbal medicines as to conventional pharmaceuticals; they are enforced by means of herbal product registration. Special safety assessment requirements apply to herbal medicines, including traditional use without demonstrated harmful effects, reference to documented scientific research on similar products and proof of safety from the regulatory authority of the country of origin. The registration system also enforces implementation of these requirements.

There is a national herbal medicines registration system; however, the number of registered medicines is not known. Herbal medicines are not included on an essential drug list. Jamaica has a post marketing surveillance system that includes adverse effect monitoring. Consumers and health professionals are encouraged to report to the authorities using an adverse drug report form. In Jamaica, herbal medicines are sold in pharmacies as prescription and over the counter medicines, in special outlets and by licensed practitioners.

Mexico

The national policy of the United Mexican States was introduced in 2001; however, no laws or regulations have been issued or are being planned. The national programme was issued in 2001 in the Work Plan of the National Office, the Dirección de Medicina Tradicional (Traditional Medicine Directorate) for 2001 2006. The office is part of the Ministry of Health. In 2001, an expert committee on TM/CAM was created. National research institutes for traditional medicine include the National Institute of Anthropology and History and for herbal medicine the Herbarium of the Mexican Institute of Social Security.

In Mexico, regulation of herbal medicines was established in 1997; the law is partly the same as for conventional pharmaceuticals. Herbal medicines are regulated as prescription and over the counter medicines, dietary supplements, health foods and herbal remedies. By law, medical, health and structure/function claims may be made. The national pharmacopoeia, Farmacopea Herbolaría de los Estados Unidos de Mexico (2001), is legally binding. The national pharmacopoeia also includes monographs.

Manufacturing requirements include the same GMP rules as for conventional pharmaceuticals, but also include adherence to information in pharmacopoeias and monographs and special GMP rules for herbal medicines. Implementation of these requirements is enforced through inspections. Safety assessment regulatory requirements are the same as for conventional pharmaceuticals, but also include references to documented scientific research on similar products, as well as the results of microbiological analysis and the absence of toxic residues. Inspections also serve as the control mechanism for safety requirements.

There is a registration system, but it is not known how many herbal medicines are registered. Two herbal medicines are listed on the national essential drug list. There is a system of post marketing surveillance, which includes a national adverse effect monitoring system established in 2000. In Mexico, herbal medicines are sold in pharmacies as prescription and over the counter medicines and in special outlets.

Nicaragua

Although Nicaragua does not have a national policy, laws or regulations on TM/CAM, they are currently being developed. No national programme has been introduced. The national office is being established. The national expert committee on TM/CAM was established in 2003. No national research institutes have been established for TM, CAM or herbal medicines.

The regulation of herbal medicines was introduced in 1998 through Law 292, the national pharmaceuticals law. This law also regulates conventional pharmaceuticals; however, there are also special rules that apply only to herbal medicines. Herbal medicines are regulated as prescription medicines, over the counter medicines, dietary supplements, health foods and functional foods. By law, herbal medicines may be sold with medical, health, nutrient content and structure/function claims.

Although no national pharmacopoeia currently exists, one is being developed. No information is available on the other pharmacopoeias currently used and legally binding. Sixty three national monographs on herbal medicines may be found in the Compendia de Plantas Medicinales (2000). In addition, monographs in the Farmacopoeia caribeña are used; both are considered to be legally binding.

Regulatory requirements for manufacturing include the same GMP rules as for conventional pharmaceuticals and special GMP rules. No control mechanism exists to ensure compliance with these requirements. Safety assessment requirements include those used for conventional pharmaceuticals and special requirements of traditional use without demonstrated harmful effects and reference to documented scientific research on similar products. No control mechanism has been established for safety assessment requirements.

There is a registration system for herbal medicines; however, the number of registered herbal medicines is not available. No herbal medicines are included on the national essential drug list. A post marketing surveillance system is currently being planned for herbal medicines. In Nicaragua, herbal medicines are sold in pharmacies as over the counter medicines, in special outlets, by licensed practitioners, without restriction and in indigenous communities.

Peru

In 1990, in Legislative Decree No. 584 and Supreme Decree No. 002 92 SA, the Republic of Peru established a national policy on TM/CAM laws. Regulations and a national programme are being developed. The national office, the Instituto Nacional de Medicina Traditional (National Institute of Traditional Medicine, INMETRA) was established in 1990. In 2002, in Law No. 27657, INMETRA was included in the Instituto Nacional de Salud (National Institute of Health), changing its name to Centro Nacional de Salud Intercultural (National Centre for Intercultural Health, CENSI). CENSI leads national research efforts in TM/CAM. CENSI also promotes the implementation of TM services, as well as CAM within the National Health Coordinated and Decentralized System.

In 1997, Peru established regulations on herbal drugs and medicines through the same law used for conventional medicines. Herbal medicines are regulated as over the counter medicines and dietary supplements. According to the law, herbal medicines may be sold, depending on their health and nutritional content. A technical committee led by CENSI has been formed for the regulation of Law No. 27399 on Sustainable Utilization of Medicinal Plants, and Law No. 27821 on Promotion of Nutritional Complements for Alternative Development.

There is no national pharmacopoeia. There are no national monographs. No information is available on manufacturing requirements or their enforcement. Safety requirements are limited to the stipulation of traditional use without demonstrated harmful effects; there is no control mechanism for this regulatory requirement. Currently CENSI is developing the Peruvian Medicinal and Related Plants Pharmacopoeia Project, the Medicinal Plants National Herbarium and biogardens and botanical gardens nationwide.

There is a registration system for herbal medicines, but there is no information as to the number of herbal medicines registered. None are on the list of essential drugs. The establishment of a post marketing surveillance system is being considered. Herbal medicines in Peru are sold as over the counter medicines without restriction.

Suriname

In the Republic of Suriname, no national policy, laws, regulations, national programme or national office on TM/CAM exist, nor are they in the process of being developed. There is also no expert committee and there are no national research institutes on TM/CAM or herbal medicines.

Herbal medicines are not regulated in Suriname and consequently have no regulatory status, nor can claims be legally made about them. Neither a national pharmacopoeia nor national monographs exist, and no information is available on other materials used in their place.

No information is available on manufacturing regulatory requirements or any control mechanism to ensure compliance. Safety regulations are limited to reference to scientific research on similar products; no information is available on a control mechanism for this requirement. No registration system exists for herbal medicines, nor are they included on a national essential drug list. No post marketing surveillance system for herbal medicines exists, nor is one being planned. In Suriname, there are no restrictions on the sale of herbal medicines.

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