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
 

5.1 WHO African Region

Countries that responded to the survey: African Region

Thirty seven of the 46 countries in the WHO African Region responded to the Global Survey. Table 4 summarizes the development of national policy and regulation of TM/CAM and herbal medicines in the African Region, with comparative figures for all of 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 4. WHO African Region: positive responses

 

Member States in the African Region which responded positively

Regional survey % that responded positively (37)

Global survey % that responded positively (141)

National policy on TM/CAM

12

32%

32%

Law or regulation on TM/CAM

10

27%

38%

National programme on TM/CAM

15

41%

28%

National office for TM/CAM

25

68%

53%

Expert committee on TM/CAM

16

43%

43%

National research institute on TM, CAM or herbal medicines

18

48%

41%

Law or regulation on herbal medicines

12

32%

65%

Registration of herbal medicines

8

21%

61%

The data clearly indicate that significant progress has been made in the WHO African Region regarding the development of national policies and regulations on traditional and complementary/alternative medicines. In particular, the high number of countries with national programmes, national offices and national research institutes on TM/CAM demonstrates an expanding commitment among African Region countries to promote and develop the scientific basis of African traditional medicines. In this region, however, the development of national policies and regulation, particularly for herbal medicines, is much more limited, especially in comparison with the Global Survey response figures.

Angola

There is no national policy on TM/CAM in the Republic of Angola. Laws and regulations are currently being developed, as is a national programme. The national office on TM/CAM was established in 1998 under the direction of the Ministry of Health. The expert committee was established in the same year. There are no national research institutes on TM, CAM or herbal medicines.

There is no regulation of herbal medicines in Angola. Herbal medicines are classified as over the counter medicines. By law, no claims may be made about herbal medicines.

A national pharmacopoeia is currently in development, as are national monographs on herbal medicines. There is no information available on manufacturing requirements or safety requirements for herbal medicines. There is no registration system for herbal medicines; no herbal medicines are included on a national essential drug list. There is no information on a post marketing surveillance system for herbal medicines. Herbal medicines in Angola are sold in special outlets, by licensed practitioners and in markets.

Benin

The Republic of Benin established a national policy in 2002, a law or regulation concerning TM/CAM was adopted in 2001, and a national programme on TM/CAM was put in place in 1999. A TM/CAM office has existed since 1997 under the Ministry of Health. The expert committee was established later in 2001. No national research institute exists for the study of TM/CAM and herbal medicines.

Benin does not regulate herbal medicines; herbal medicines are classified only as over the counter medicines and for self medication and can be sold with medical, health, nutrient content, and structure/function claims. No national pharmacopoeia or national monograph exists, although both are currently being developed. In the meantime, nothing is used. There are no regulatory requirements for manufacturing or safety assessment of herbal medicines. There is no system of registration and herbal medicines are not included on the essential drug list. No post marketing surveillance exists, though a system is being established. Herbal medicines are sold either as over the counter drugs in pharmacies, or without regulation.

Botswana

The Republic of Botswana does not currently have a national policy on TM/CAM, although this is in the process of development. Data were lacking on the existence of laws or regulations and a national programme on TM/CAM. Although Botswana does not currently have a national office, it was reported that such a national office is in development. Botswana does have an expert committee on TM/CAM, established in 2001 - the Health Education Unit in Gaborone. There are no national research institutes on TM, CAM or herbal medicines.

Information is not available on the regulation of herbal medicine, but in Botswana, no herbal medicine has any regulatory status. Again, no information is available about claims made for the sale of herbal medicine, nor about the claims that are allowed by law or regulation. Botswana does not have a national pharmacopoeia, nor is one in the process of development.

No information was provided regarding the existence of national monographs or the regulatory requirements for the manufacture of herbal medicine. Botswana does not have any control mechanism for the manufacture of herbal medicine. No regulatory requirements exist regarding safety; unprocessed herbal medicines without clinical claims are exempt from regulation as a medicine. Therefore, safety and regulation issues do not apply. Data are likewise incomplete regarding registration, inclusion on the essential drug list, post marketing surveillance system and market sale information.

Burkina Faso

Burkina Faso currently has no national policy, laws or regulations, nor a national programme on TM/CAM, but has reported that all three are being developed. A national office on TM/CAM exists; the Service de médecine et pharmacopée traditionnelles (Traditional Medicine and Pharmacopoeia Service) was established in 1987 and is administered by the Ministry of Health in Ouagadougou. The expert committee on TM/CAM in Burkina Faso was founded in 2000. Burkina Faso does not have research institutes on TM or CAM, but does have one on herbal medicine, founded in 1983, called the Institut de recherche en sciences de la santé (Institute for Health Sciences Research).

Burkina Faso has a national regulation on herbal medicine, which is partly the same type as for conventional medicine. The national regulation on herbal medicine is part of the public health code, No. 23/94/ADP, established in 1994. The relevant regulatory categories of herbal medicine are over the counter drug and dietary supplements. Herbal medicines are sold with claims in Burkina Faso; by law or regulation, herbal medicines can be sold with medical and nutrient content claims. Burkina Faso does not have a national pharmacopoeia, and uses the Senegalese pharmacopoeia (1974), but it is not legally binding. Likewise, Burkina Faso does not have national monographs, but uses those in the African pharmacopoeia (1985), which contains 261 monographs. It is not legally binding.

Regarding the regulatory requirements for manufacturing, the rules of GMP used for conventional pharmaceuticals also apply to herbal medicines. There is no control mechanism for the application of these requirements. The regulatory requirements for safety are limited to special requirements that include traditional use without demonstrated harmful effects and references to documented scientific research on similar products; no control mechanism exists for these requirements.

No registration system for herbal medicines exists, and herbal medicines are not included on a national essential drug list. A post marketing surveillance system exists, but no system yet exists for monitoring adverse effects of herbal medicines. In Burkina Faso, herbal medicines are sold in pharmacies as over the counter medicines, in special outlets and by licensed practitioners. Burkina Faso reported annual market sales figures for 1998 2000, estimated by the National Traders Network. In 1998, the annual market sales for herbal medicines were 1.5 billion CFA francs (US$ 2.68 million), in 1999 sales were 1.8 billion CFA francs (US$ 3.22 million) and in 2000, sales were 3 billion CFA francs (US$ 5.37 million).

Burundi

The Republic of Burundi does not currently have national policy or laws and regulations on TM/CAM, but they are currently in development. Burundi has a national office on TM/CAM, administered under the Ministry of Health and established in 2002. A national expert committee was established in 2002 as well. National research institutes exist for traditional medicine and for herbal medicines; however, the dates of establishment and names of the institutes are not available.

Burundi does not regulate herbal medicine, but it was reported that herbal medicines have the regulatory statuses of over the counter sale medicines and for self medication only. Herbal medicines in Burundi are not sold with claims. Burundi does not have a national pharmacopoeia, nor is one pending, but uses other pharmacopoeias that are not legally binding. No national monographs exist, nor are any used in their place.

The relevant regulatory requirements for manufacturing are the same GMP rules as for conventional medicines, but these are not enforced by any control mechanism. No regulatory requirements for safety assessment exist. Burundi does not have a registration system for herbal medicines, nor are herbal medicines included on the national essential drug list. A post marketing surveillance system is currently in development. Herbal medicines in Burundi are sold in special outlets and by licensed practitioners with no restrictions.

Cameroon

The Republic of Cameroon currently does not have national policy or laws and regulations on TM/CAM, but a national policy is being developed. A national programme was established in 2001 called the Etude de la médecine traditionnelle (School of Traditional Medicine). A national office was established in 1995, and is administered by the Ministry of Health. No expert committee exists. National research institutes on traditional medicine and herbal medicine have been established.

In Cameroon, national regulation of herbal medicine was introduced in 1998 in Decree No. 98/405/PM. The regulation is partly the same for herbal medicines as for conventional pharmaceuticals. Herbal medicines in Cameroon have regulatory status as prescription medicines, over the counter medicines and for self medication. Health and medical claims may be made about herbal medicines. Cameroon does not have a national pharmacopoeia, but uses the European pharmacopoeia. No national monographs exist, nor are other monographs used in their place.

Regulatory requirements for manufacturing of herbal medicines are the same GMP rules required for conventional medicines; the implementation of these requirements is controlled through inspection. Requirements for safety assessment of herbal medicines include special requirements of traditional use without demonstrated harmful effects and references to documented scientific literature on similar products, but no control mechanism exists for these.

A registration system for herbal medicines exists in Cameroon, and currently 10 medicines are registered. One herbal medicine is included on the national essential drug list established in 1999. A post marketing surveillance system is in development. Finally, sales of herbal medicines in Cameroon include sales in pharmacies as prescription medicines and over the counter medicines, in special outlets and by travelling pedlars.

Central African Republic

In the Central African Republic, a national policy and laws and regulations and a national programme on TM/CAM are in development. The national office on TM/CAM was established in 1997 under the administration of the Ministry of Health. An expert committee on TM/CAM was created in 1995. No national research institutes on TM/CAM and herbal medicines exist.

There is no regulation of herbal medicines in the Central African Republic and there is no regulatory status applied to herbal medicines. No claims may be made about herbal medicines. A national pharmacopoeia and national monographs are the process of being developed.

There are no manufacturing or safety assessment regulatory requirements. In the Central African Republic, there is also no registration of herbal medicines, nor are herbal medicines included on the essential drug list. A post marketing surveillance system is currently in development. No restrictions exist on the sale of herbal medicines in the Central African Republic.

Chad

In the Republic of Chad, a national policy, laws and regulations on TM/CAM are currently in development. The national programme on TM/CAM was established in 2002, while the national office on TM/CAM was created in 2001 under the Ministry of Health. No committee of experts exists; however, national research institutes on traditional medicine and on herbal medicine were founded in 1993.

Chad does not regulate herbal medicines, therefore there is no regulatory status for herbal medicines, nor can claims be made by law. There is no national pharmacopoeia, nor are there national monographs, and no other instruments are used in their place. There are no manufacturing or safety assessment requirements, nor is a registration system in place. Herbal medicines are not listed on the essential drug list. A post marketing surveillance system is being developed. There are no restrictions on the sale of herbal medicines.

Comoros

In the Islamic Federal Republic of the Comoros (now the Union of the Comoros), there are no national policy, laws or regulations, and none is in development. A national office was established in 2002 under the Ministry of Health. There is no expert committee on TM/CAM. A national research institute on traditional medicine was founded in 1979, called the Centre national de documentation et de recherche scientifique (National Documentation and Scientific Research Centre - NDRS).

Comoros does not regulate herbal medicines, although herbal medicines have a regulatory status of over the counter medicines. No claims can legally be made about herbal medicines. There is no national pharmacopoeia, nor are there national monographs, and none are used in their place. There are no manufacturing or safety assessment requirements, nor is a registration system in place. Herbal medicines are not listed on the essential drug list. No post marketing surveillance system exists. Herbal medicines are on free sale in the Comoros.

Congo

The Republic of the Congo does not have a national policy on TM/CAM, and is not currently establishing one. However, a bill on traditional medicine has been presented to the Parliament and is awaiting approval. The national programme was issued in 1982. Decree No. 82 228 also established the national office on TM/CAM. The national office, the Service de la médecine traditionnelle (Traditional Medicine Department) is administered by the Ministry of Health. There is no expert committee on TM or CAM, nor are there national research institutes on TM/CAM or herbal medicine.

Congo does not regulate herbal medicines; there is no regulatory status given to herbal medicines and no claims can legally be made. A national pharmacopoeia is currently being developed: at present, the African pharmacopoeia (1985) is used. No national monographs exist, and no others are used in their place.

The relevant manufacturing regulatory requirements include adherence to the information contained in pharmacopoeias and monographs. Special GMP rules apply to herbal medicines, but no control mechanism exists to ensure implementation of these requirements. The regulatory requirements for safety assessment include all of the following: the same requirements as 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 exists for these requirements for safety assessment of herbal medicines.

No registration system exists, and herbal medicines are not included on an essential drug list. The post marketing surveillance system is being developed. No restrictions are made on the sale of herbal medicines. Estimates of market sales for 2001 2003 about the growth of the market are 25%, 30% and 20%, respectively.

Côte d’Ivoire

In the Republic of Côte d’Ivoire, the national policy on TM/CAM was established in 1996. The laws or regulations about TM/CAM were established in 1999 by the Council of Ministers. The national programme on TM/CAM was issued through the Ministerial Decree of 28/12/2002. The national office, established in 2002, is called the Programme national de promotion de la médecine traditionnelle (National Programme for the Promotion of Traditional Medicine) and is located in Abidjan, Côte d’Ivoire. The expert committee on TM/CAM was also established in 2002. No national research institutes on TM, CAM or herbal medicines have been established in Côte d’Ivoire.

Herbal medicines are not regulated in Côte d’Ivoire; no regulatory status is given to herbal medicines and no claims can be legally made. Neither a national pharmacopoeia nor national monographs exist, although the latter are in development. No regulatory requirements exist for manufacturing or safety assessment, since the programme has only recently been established. No registration system exists, and herbal medicines are not included on an essential drug list. The post marketing surveillance system is being developed. Herbal medicines are freely sold by their makers in Côte d’Ivoire.

Democratic Republic of the Congo

In the Democratic Republic of the Congo, a national policy and laws and regulations on TM/CAM are currently being developed. The national programme was issued in 2002 through ministerial decree No. 1250, on the Organization of the Exercise of the Profession of Practitioner of Traditional Medicine. The national office was also established in 2002 as the Programme national de promotion de la médecine traditionnelle et des plantes medicinales (National Programme for the Promotion of Traditional Medicine and Medicinal Plants), administered by the Ministry of Health. The expert committee was created in 1997. The national research institute, the Institut de recherché en sciences de santé (Institute for Health Sciences Research), founded in 1976, conducts research on traditional medicine and herbal medicine.

Regulation of herbal medicines was established in 2001 through ministerial decree. The regulation is the same as that for conventional pharmaceuticals. In the Democratic Republic of the Congo, herbal medicines have regulatory status as prescription medicines and over the counter medicines. Herbal medicines are sold with claims; according to law, medical, health, nutrient content and structure/function claims are possible.

There is no national pharmacopoeia, nor is one being developed; the African pharmacopoeia (1985) is used and is legally binding. Likewise, there are no national monographs, nor are they in development; the WHO monographs are used and are legally binding. The relevant regulatory requirements for manufacturing are adherence to information in pharmacopoeias and monographs and the same GMP rules as for conventional pharmaceuticals; however, there is no control mechanism for these requirements. Regulatory requirements for safety assessment include the following: the same requirements as for conventional pharmaceuticals as well as special requirements of traditional use without demonstrated harmful effects and reference to documented scientific research on similar products. The implementation of these requirements for safety assessment is ensured through compulsory submission of the results of toxicological assays.

There is a registration system for herbal medicines; 15 medicines are registered. The essential drug list includes six herbal medicines and was issued in 2001. A post marketing surveillance system exists and includes adverse effect monitoring, established in 1982. In the Democratic Republic of the Congo, herbal medicines are sold in pharmacies as prescription medicines and over the counter medicines.

Equatorial Guinea

In the Republic of Equatorial Guinea, a national policy on TM/CAM was issued in 1999 and laws and regulations on TM/CAM were issued in 1985. There is no national programme; however, one is in development. The national office, Service médecine traditionnelle (Traditional Medicine Department), administered by the Ministry of Health and Social Welfare, was established in 1995. There is no expert committee. The national research institute, Conseil pour la recherche scientifique et technique (Council for Scientific and Technical Research), was established in 1989 and covers both traditional and herbal medicine research.

Regulation of herbal medicines in Equatorial Guinea was established in 1985 through special legislation applying only to herbal medicines, through Law No. 4/1985, which also created the Traditional Medicine Department. Herbal medicines have the regulatory status of over the counter medicines and self administered medications. By law, medical, nutrient content and structure/function claims may be made about herbal medicines.

No national pharmacopoeia exists, nor is one planned; furthermore, no pharmacopoeia is used in its place. National monographs exist in the Recetario plantas medicinales de Equatorial Guinea (1996), which contains 18 monographs. The information is not legally binding. No requirements exist for manufacturing; however, special requirements of traditional use without demonstrated harmful effects exist for safety assessment, and these are enforced by supervision visits to the traditional practitioners.

There is no system of registration, and herbal medicines are not included on the essential drug list. No post marketing surveillance exists or is in preparation. There are no restrictions on the sale of herbal medicines: however, they are sold through special outlets and licensed practitioners.

Ethiopia

In the Federal Democratic Republic of Ethiopia, the national policy on TM/CAM was issued in the Health, Drug, Science and Technology Policy of 1999. Laws and regulations on TM/CAM were issued in the Drug Administration and Control Proclamation No. 176/99 of 1999. The national programme is one of the responsibilities of the Drug Administration and Control Authority (DACA) established by Proclamation No. 176. DACA, administered by the Ministry of Health, was established as the focal point for the national office on TM/CAM in 2000. The expert committee is also part of DACA. Finally, the national research institute covering both traditional and herbal medicines is the Drug Research Department of the Ethiopian Health and Nutrition Institute.

Ethiopia does not regulate herbal medicine and no regulatory status exists for herbal medicine: however, herbal medicines are sold with medical claims. There is no national pharmacopoeia or national monographs. No regulatory requirements exist for manufacturing or for safety assessment. There is no registration system, herbal medicines are not included on an essential medicines list, nor is there a post marketing surveillance system. There are no restrictions on the sale of herbal medicines in Ethiopia.

Gabon

The Gabonese Republic issued its national policy in 1995 in Ordinance No. 001/95, which officially recognizes traditional medicine in the overall Gabon health policy. No laws or regulations on TM/CAM have been issued, but these are in the process of development, as is the national programme. The national office, administered by the Ministry of Health, was established in 2000. No expert committee exists. A research institute on traditional medicine and herbal medicine has been established.

However, Gabon does not regulate herbal medicine. No regulatory status is given to herbal medicines and no claims can legally be made. Neither a national pharmacopoeia nor national monographs exist. There are no regulatory requirements for manufacturing or safety assessment. No registration system exists, and herbal medicines are not included on an essential drug list. The post marketing surveillance system is being developed. Herbal medicines are sold in special outlets without any restrictions.

The Gambia

In the Republic of the Gambia, national policy is in the process of being developed. Laws and regulations on TM/CAM do not exist, nor are they currently in development. A national programme exists, but no information was provided as to when it was established. The national office, administered by the Ministry of Health, was established in 2000 as part of the national acute respiratory infection control programme. The expert committee on TM/CAM was established in 2002. No national research institutes exist for study of TM/CAM or herbal medicines.

The Gambia does not currently regulate herbal medicines. No regulatory status is given to herbal medicines, and no claims can legally be made. Neither a national pharmacopoeia nor national monographs exist. There are no regulatory requirements for manufacturing or safety assessment. No registration system exists, and herbal medicines are not included on an essential drug list. There are no restrictions on sale of herbal medicines in the Gambia.

Ghana

In the Republic of Ghana, the national policy on TM/CAM was issued in 2002. Laws and regulations on TM/CAM were issued in 1992, and the national programme in 2000. The national office on TM/CAM was established in 1999 under the direction of the Ministry of Health. The expert committee was also established in the same year. A national research institute on herbal medicines was established in 1975.

Herbal regulation in Ghana began in 1992 through the Food and Drugs Law, which also establishes regulations on conventional pharmaceuticals. Herbal medicines are regulated as over the counter medicines and as a separate regulatory category. By law, medical, health and nutrient content claims may be made. The Ghana herbal pharmacopoeia was published in 1992; it is not considered to be legally binding. The national pharmacopoeia also contains monographs on herbal medicines.

Regulatory requirements for manufacturing of herbal medicines include the same GMP rules that apply to conventional pharmaceuticals and special GMP rules. While a large proportion of manufacturers of herbal medicines in Ghana are small scale industries, efforts have been made to provide training in GMP compliance. Implementation of the manufacturing requirements is ensured through annual inspections. Safety assessment requirements include traditional use without demonstrated harmful effects, reference to documented scientific research on similar products and phytochemical analysis. Compliance with these requirements is ensured through the pharmacovigilance centre.

There are 340 registered herbal medicines in Ghana; however, none is included on the national essential drug list. The national post marketing surveillance system has included adverse effect monitoring of herbal medicines since 2000. In Ghana, herbal medicines are sold in pharmacies as over the counter medicines, in special outlets and by licensed practitioners.

Guinea

The Republic of Guinea established its national policy on TM/CAM in 1994; laws and regulations on TM/CAM followed in 1997. No national programme exists, but one is in development. The national office was established in 1977, is administered by the Ministry of Health and is called the Division de médecine traditionelle (Traditional Medicine Division). An expert committee called the Thematic Group on TM/CAM was created in 1999. A national institute on herbal medicines was established in 2001.

Regulation of herbal medicines in Guinea began in 1994, and is characterized as being partly the same laws and regulations as for conventional pharmaceuticals. Herbal medicines are regulated as prescription medicines, over the counter medicines, self medication and as herbal medicines as a separate regulatory category. No claims may be made according to law. No national pharmacopoeia exists, but one is in development; other pharmacopoeias are used, but details were not given, and they are not legally binding. National monographs exist in the Plantes médecinales guinéennes (1997), but they are not legally binding.

Regulatory requirements for manufacturing include adherence to the information contained in pharmacopoeias and monographs and special GMP for herbal medicines; however, there is no control mechanism to ensure implementation. The regulatory requirements for safety assessment include the special requirements of traditional use without demonstrated harmful effects and reference to documented scientific research on similar products. Again, there is no control mechanism for these requirements.

There is no registration system for herbal medicines and they are not included on the essential drug list. A post marketing surveillance system is in development. Herbal medicines in Guinea are sold in pharmacies as prescription and over the counter medicines without restriction.

Guinea Bissau

The Republic of Guinea Bissau has no national policy, laws or regulations, national programme, national office, expert committee or research institutes related to TM/CAM.

Guinea Bissau does not regulate herbal medicines, and they are treated as over the counter medicines, about which claims cannot be made. Neither a national pharmacopoeia nor national monographs exist; however, they are in the process of development. No other materials are used in their place. There are no regulatory requirements for manufacturing or safety assessment. No registration system exists, and herbal medicines are not included on an essential drug list. There are no restrictions on sale of herbal medicines in Guinea Bissau.

Kenya

In the Republic of Kenya, a national policy, laws and regulations on TM/CAM are being developed. No national programme has been issued, and no national office or expert committee have been established. A national research institute that conducts research on traditional medicine was established in 1984, called the Kenya Medical Research Institute.

Herbal medicines are not regulated in Kenya. Neither a national pharmacopoeia nor national monographs exist or are being developed. No other pharmacopoeias or monographs are used in their place.

No information was provided on manufacturing requirements, but special regulatory requirements for safety assessment of traditional use without demonstrated harmful effects and reference to documented scientific research on similar products apply to herbal medicines. These have been established by the Kenya Medical Research Institute, but no control mechanism exists to ensure their implementation.

There is no registration system for herbal medicines and they are not included on the essential drug list. A post marketing surveillance system is in development. Herbal medicines in Kenya are sold without restriction.

Madagascar

The Republic of Madagascar has a national policy, laws and regulations and a national programme on TM/CAM in development. The national office was established under the Ministry of Health in 2002 and is called the Service de la médecine et pharmacopées traditionnelles (Department of Traditional Medicine and Pharmacopoeias). There is no expert committee. Two national research institutes on herbal medicine exist: the Institut malgache de recherche appliquée (Malagasy Institute of Applied Research - IMRA) was founded in 1958 and the Centre national d application des recherches pharmaceutiques (National Centre for the Application of Pharmaceutical Research - CNARP) in 1971.

Madagascar does not regulate herbal medicines; they are classified as over the counter medicines. By law, medical, health, nutrient content and structure/function claims may be made. Neither a national pharmacopoeia nor national monographs exist; however, they are in the process of development. No other materials are used in their place.

Manufacturing regulatory requirements include adherence to the information contained in pharmacopoeias and monographs, GMP rules for conventional pharmaceuticals and special GMP rules. There is no control mechanism for these requirements. Safety assessment regulatory requirements include those required for conventional pharmaceuticals, and special requirements of traditional use without demonstrated harmful effects and reference to documented scientific research on similar products apply to herbal medicines. There is, however, no control mechanism for these requirements.

There is no registration system for herbal medicines and they are not included on the essential drug list. A post marketing surveillance system is in development. Herbal medicines in Madagascar are sold without restriction in pharmacies as over the counter medicines and in special outlets.

Madagascar provided annual market sales data for the period 1999 2001. In 1999, sales were 15.71 million Malagasy francs (US$ 2 million) and involved 417 051 kg of herbal medicines; in 2000, sales were 18.28 million francs (US$3.15 million) and involved 580 401 kg of herbal medicines; and in 2001, 20.78 million francs (US$ 3.59 million) and 320 609 kg of herbal medicines. These figures are from the Institut national de la statistique (National Statistics Institute - INSTAT).

Malawi

In the Republic of Malawi, no information is available about the national policy on TM/CAM. Laws and regulations on TM/CAM are pending, as is the national programme. No information is available about a national office, expert committee or national research institute.

Herbal medicines are regulated by the same laws that are used for conventional pharmaceuticals. No information is available on their regulatory status. Herbal medicines may be sold by law with medical and structure/function claims.

No information is available about the existence or development of a national pharmacopoeia, or whether other pharmacopoeias are used. No national monographs exist. No information is available about regulatory requirements for manufacturing or safety assessment. There is no registration system for herbal medicines and they are not included on the essential drug list. A post marketing surveillance system is in development. There is no market information for Malawi on the methods of sale of herbal medicines.

Mali

While the Republic of Mali does not currently have a national policy on TM/CAM, such a policy is in development. Laws, regulations and the national programme on TM/CAM were issued in 1973. In 1968, the national office was established as the Département médecine traditionnelle (Traditional Medicine Department) under the Ministry of Health. No expert committee for TM/CAM exists: however, national research institutes were established in 1968 as part of the Traditional Medicine Department.

Regulations on herbal medicines were issued in 1994 which are partly the same as those governing conventional pharmaceuticals. Herbal medicines are regulated as over the counter medicines and may, by law, be sold with medical claims. No national pharmacopoeia exists; in its place the African pharmacopoeia (1985) is used, but is not legally binding. National monographs exist in the Formulaire thérapeutique (1998), which contains seven monographs, but those are not legally binding.

Regulatory requirements for manufacturing include adherence to information in pharmacopoeias and monographs, as well as good conditions for harvest, drying, extraction and packaging and quality control. Implementation of these requirements is ensured by laboratory testing for content and foreign substances and by ensuring correct identification of plants and standardized extracts. Safety assessment regulatory requirements include special requirements of traditional use without demonstrated harmful effects and reference to documented scientific research on similar products. Implementation is ensured by means of toxicity testing.

The registration system for herbal medicines includes seven medicines, as does the essential drug list. A post marketing surveillance system exists that includes adverse effect monitoring of herbal medicines; it was established in 1990. Herbal medicines in Mali are sold in pharmacies as over the counter medicines and in herb shops.

Mauritania

Although the Islamic Republic of Mauritania does not currently have a national policy on TM/CAM, one is in the process of development. No laws or regulations yet exist on TM/CAM; a national programme has also not been issued. No national office exists, although one is being planned. No expert committee exists, nor do research institutes on TM/CAM or herbal medicine.

Mauritania does not regulate herbal medicines; they are categorized as over the counter medicines, self medication, herbal medicines, dietary supplements or health foods. No claims can legally be made about them. A national pharmacopoeia and national monographs are in development; no other materials are used in their place at present.

Regulatory requirements for manufacturing are restricted to adherence to information in pharmacopoeias and monographs. Requirements for safety assessment are restricted to the special requirement of traditional use without demonstrated harmful effects and reference to documented scientific research on similar products. No information is available on the control mechanisms for these regulatory requirements. No registration system exists for herbal medicines. A post marketing surveillance system is in development. There are no restrictions on the sale of herbal medicines in Mauritania.

Mozambique

The Republic of Mozambique currently has a national policy which was approved recently, while laws and regulation on TM/CAM are being developed. There is a national programme on TM/CAM, and a national office was established in 1977, which is administered by the Ministry of Health. The expert committee for TM/CAM was created in 2000. While no national research institutes on TM, CAM or herbal medicines exist separately, there is a Department of Studies of Medicinal Plants and Traditional Medicine in the National Institute of Health.

Herbal medicine is not regulated in Mozambique, so no regulatory status exists for herbal medicines and no claims may be made by law. In place of a national pharmacopoeia, the African pharmacopoeia (1985) is used and is legally binding. The national monographs are contained in the series Plantas Medicinais e seu uso tradicional em Mocambique (1983 1991, five volumes). The information in this series is legally binding.

As there is no manufacture of herbal medicine in the country, no regulatory requirements or safety assessment requirements exist. There is no registration system for herbal medicines, and they are not included on the essential drug list. A post marketing surveillance system is in development. Herbal medicines are sold in pharmacies as over the counter medicines with no restrictions.

Niger

The Republic of the Niger is currently developing its national policy on TM/CAM, but laws and regulations were issued in 1997, and the national programme on traditional medicine was issued in 2001. The national office was established in 1995 under the administration of the Ministry of Health; however, no expert committee has been established, nor have any national research institutes on TM, CAM or herbal medicines.

Niger began regulation of herbal medicines in 1997, using legislation that is partly the same as that which regulates conventional pharmaceuticals. Under this regulation, herbal medicines are classified in the following regulatory categories: over the counter medicines, self medication, dietary supplements and functional foods. No claims may be made under these laws. Niger’s national pharmacopoeia is in development, and those pharmacopoeias used in its place are legally binding. National monographs are contained in the Inventaire des plantes medecinales (2000), which contains 339 monographs. It is not legally binding.

The relevant regulatory requirements for manufacturing include the use of the same GMP rules as for conventional pharmaceuticals and special GMP rules. The implementation of these requirements is ensured by the Laboratoire national de santé publique et d’expertise (National Laboratory of Public Health and Expert Evaluation - LANSPEX). Special requirements for safety assessment, including traditional use without demonstrated harmful effects and reference to documented scientific research on similar products, apply to herbal medicines; the implementation of these requirements are also ensured by LANSPEX.

There is a registration system for herbal medicines, and currently one product is registered. The national essential drug list includes one herbal medicine; it was issued in 2000. A post marketing surveillance system is in development. Herbal medicines in Niger are sold in pharmacies as over the counter medicines, in special outlets and by licensed practitioners.

Nigeria

The Federal Republic of Nigeria is currently developing a national policy on TM/CAM. Laws and regulations were issued in 1993 and revised in 1999. A national programme is also pending. The national office was established in 1997, and is administered by the Federal Ministry of Health. The expert committee on TM/CAM was created in 1978. Nigeria has two national research institutes on TM/CAM and herbal medicines, founded in 1988 and 1992. They are the Nigeria Natural Medicines Development Agency in Lagos, Nigeria and the National Institute for Pharmaceutical Research and Development.

Regulation of herbal medicines was introduced in Nigeria in 1993 in Decree No. 15, and was revised in 1999. Herbal medicines are regulated as dietary supplements, health foods, functional foods and as an independent regulatory category. Claims that may be made about herbal medicines include health, nutrient content and structure/function claims in accordance with the law. The Nigerian national pharmacopoeia and national monographs are in development, but no other materials are used in their place at present.

Manufacturing regulatory requirements are restricted to good hygienic practices and are enforced through checklists drawn up by the regulatory agency. Special requirements for safety assessment exist, including traditional use without demonstrated harmful effects; compliance with these requirements is ensured through animal studies to assess acute toxicity. There are currently 107 registered herbal medicines in Nigeria, but none is listed on the essential drug list. A post marketing surveillance system is in development. In Nigeria, herbal medicines are sold without restriction by licensed practitioners.

Rwanda

The Rwandese Republic is currently developing laws and regulations on TM/CAM, but neither a national policy nor a national programme are planned. No national office exists, nor are there plans to develop one. There is no expert committee. The national research institute on traditional medicine and herbal medicines, the Institut de recherche scientifique et technologique (Scientific and Technological Research Institute - IRST) was established in 1982 (Pharmacopeé traditionnelle).

Herbal medicines are not currently regulated in Rwanda; they are categorized as over the counter medicines, self medication and dietary supplements. By law, medical claims may be about herbal medicines. No national pharmacopoeia exists; however the Pharmacopeé belge (IV. ed.), the Pharmacopeé française (IX. ed.) and the Pharmacopeé japonaise (XI. ed.) are used, but are not legally binding. National monographs are being developed.

Regulatory requirements for herbal medicines include adherence to information in pharmacopoeias and monographs and the same rules of GMP as are used for conventional pharmaceuticals. Implementation of these requirements involves internal controls and consultation with the International pharmacopoeia and European pharmacopoeia. Safety assessment requirements are the same as those for conventional pharmaceuticals, and implementation is ensured through quality control of raw materials and manufactured products.

There is no registration system for herbal medicines, and no herbal medicines are included on the national essential drug list. A post marketing surveillance system is in development. Herbal medicines in Rwanda are sold in pharmacies as prescription and over the counter medicines. Estimates by a researcher of the annual market sales of seven herbal medicines were provided for 2000 and 2001; however, the units of measurement used (whether currency or units sold) are unclear.

Sao Tome and Principe

Currently the Democratic Republic of Sao Tome and Principe is developing a national policy, laws, regulations and a national programme on TM/CAM. No national office exists, or is currently planned. No expert committee exists, nor any national research institutes on TM/CAM or herbal medicines.

Herbal medicines are not regulated in Sao Tome and Principe. No national pharmacopoeias or national monographs exist or are in development. No formal written regulatory requirements for manufacturing exist; for safety assessment, requirements are restricted to traditional use without demonstrated harmful effects. No control mechanism exists for this requirement.

No registration system exists, nor are herbal medicines included on the national essential drug list. There is no post marketing surveillance system for herbal medicines, nor are there plans to develop one. Herbal medicines in Sao Tome and Principe are sold in special outlets.

Senegal

In the Republic of Senegal, information on the status of a national policy on TM/CAM is not available. Laws and regulations on TM/CAM are pending, and a national programme has been set up. No information is available about a national office, expert committee or national research institutes.

Herbal medicines in Senegal are not regulated. No information is available about regulatory status. Herbal medicines are sold with medical claims. No information is available on a national pharmacopoeia. No national monographs exist, nor are any in development.

Regulatory requirements for manufacturing consist of the same GMP rules as for conventional pharmaceuticals. There is no information about control mechanisms for these requirements, or about safety assessment requirements.

There is no registration system for herbal medicines and they are not included on the essential drug list. No post marketing surveillance system exists, and none is in development. There is no market information available for Senegal.

Seychelles

In the Republic of Seychelles, national policy, laws and regulations on TM/CAM are currently in development. There is currently no national programme, national office or expert committee for TM/CAM. No national research institutes exist for the study of TM/CAM and herbal medicines.

Seychelles does not regulate herbal medicines, but herbal medicines are given the status of self medication only. Neither a national pharmacopoeia nor a national herbal monograph exist or are being developed; the British pharmacopoeia is currently used, though the information is not considered legally binding. No requirements currently exist for the manufacturing or safety assessment of herbal medicines. There is no registration system for herbal medicines, and none are listed on the essential drug list. No post marketing surveillance system exists and there are no plans to establish such a system. In the Republic of Seychelles, herbal medicines are mainly sold on the premises of herbalists.

Sierra Leone

The Republic of Sierra Leone is in the process of establishing a national policy, a national programme and a national office for TM/CAM. There is no national law or regulation on TM/CAM and there are no plans to develop one. An expert committee for TM/CAM was established in 2003 at the University of Sierra Leone. No national research institutes exist for the study of TM/CAM or herbal medicines.

Sierra Leone does not regulate herbal medicines; however, they are classified as over the counter medicines and as dietary supplements. By law, no claims may be made about herbal medicines. There are no plans to develop a national pharmacopoeia or national monographs, and nothing else is used in their place. No regulatory requirements apply to the manufacturing of herbal medicines. The regulatory requirements for the safety assessment of herbal medicines are the same as for conventional pharmaceuticals, but there is no control mechanism to ensure implementation. There is a registration system for herbal medicines, but there are no available data on the number of herbal medicines registered. No herbal medicines are included on the national essential drug list. There are currently plans to establish a system for post marketing surveillance of herbal medicines, which are sold either in pharmacies as over the counter drugs or without any restrictions.

South Africa

The national policy on TM/CAM of the Republic of South Africa was issued in 1996 as part of the National Drug Policy. Laws and regulations are currently in development. The national programme on TM/CAM was issued in 2002. The national office was established in 2001 under the Ministry of Health. The Medicines Control Council serves as the expert committee for TM/CAM; it was established in 2001. While no national research institutes exist for TM, CAM or herbal medicines independently, other national research institutes have departments that cover traditional and herbal medicines.

In South Africa, herbal medicines are not currently regulated, although the laws and regulations are currently being finalized. No regulatory status yet exists for herbal medicines; however, currently they are sold for self medication only. By law, health and nutrient content claims may be made about herbal medicines.

The national pharmacopoeia is in development, as are national monographs on herbal medicines. In place of national monographs, the WHO monographs are used; however, they are not legally binding.

The manufacturing requirements for herbal medicines are the same GMP rules as those used for conventional pharmaceuticals. Compliance with these requirements is ensured through GMP inspections of herbal medicine manufacturing centres and a manufacturing licensing system. Safety assessment requirements include traditional use without demonstrated harmful effects, reference to documented scientific research on similar products and clinical data. Compliance is ensured through adherence to at least one of these requirements.

There is currently no national registration system for herbal medicines, although one is in development. No herbal medicines are included on the national essential drug list. A national post marketing surveillance system for herbal medicines is in development. In South Africa, herbal medicines are sold in pharmacies as over the counter medicines, in special outlets, by licensed practitioners and without restriction.

Togo

In the Togolese Republic, the national policy on TM/CAM was issued in 1996, and laws and regulations were issued in 2001. The national programme on TM/CAM was issued in 1996. Although there is no national office, there is a programme head for traditional medicine at the Ministry of Health, and a national office is being set up. No expert committee exists, nor any national research institutes on TM/CAM or herbal medicines.

In Togo, herbal medicine regulations were passed in 2001; this legislation is partly the same as for conventional pharmaceuticals. Herbal medicines have the regulatory status of over the counter medicines or self medication, with herbal medicines as an independent regulatory category. Claims are made for herbal medicines; these include medical and health claims as well as effects against bewitchment, sorcery and accidents.

No national pharmacopoeia exists or is being developed; in its place, the following resources are used but are not legally binding Codex français, Pharmacopeé africaine (1985) and Médecine traditionnelle et pharmacopeé: contributions aux études ethnobotaniques et floristiques au Togo (1986). No national monographs exist or are being developed; instead, the monographs contained in the annual periodical Revue de médecines et pharmacopeés africaines are used.

There are no regulatory requirements for manufacturing of herbal medicines. Safety assessment requirements include use without demonstrated harmful effects and reference to documented scientific research on similar products, but there is no control mechanism to ensure implementation.

There is no registration of herbal medicines and they are not included on the essential drug list. There is no post marketing surveillance system, and none is planned. In Togo, herbal medicines are sold without restriction in special outlets and as over the counter medicines in pharmacies.

Uganda

In the Republic of Uganda, a national policy, laws and regulations, a national programme and a national office on TM/CAM are all currently being developed. No expert committee has yet been set up. A national research institute on herbal medicines was established in 1963; it is the Natural Chemotherapeutics Research Laboratory.

Herbal medicine regulation in Uganda was established by the National Drug Authority Statute and Policy of 1993. The law for herbal medicines is the same as for conventional pharmaceuticals. There is no specific regulatory status given to herbal medicines. Claims which may be made by law include health, medical, nutrient content and cultural use claims.

The national pharmacopoeia is entitled A contribution of the traditional medicine pharmacopoeia of Uganda (1993); the information is not legally binding. No national monographs exist; however, the regional monographs of the Scientific, Technical and Research Commission of the Organization of African Unity are used.

There are no manufacturing regulatory requirements for herbal medicines: however, if they are produced for commercial use, then the medical safety and hygiene rules of the National Drug Authority inspectorate apply. There are no safety assessment requirements, and it is noted that issues of safety generally arise from the misuse of herbal medicines.

A registration system for herbal medicines was established in 2002; however no medicines are yet registered. Herbal medicines are not included on the essential drug list. No post marketing surveillance system is in place, nor is one planned. In Uganda, herbal medicines are sold in pharmacies as over the counter medicines, by pedlars and in food markets, without restriction.

United Republic of Tanzania

In the United Republic of Tanzania, a national policy was issued in 2000; laws and regulations and a national programme on TM/CAM are being developed. The national office was established in 1989 as the Traditional Medicine Section of the Department of Curative Services, administered by the Ministry of Health. No expert committee exists. The national research institute on traditional medicine, the Institute of Traditional Medicine of the Muhimbili University College of Health Sciences, was founded in 1974.

Herbal medicines are currently not regulated in the United Republic of Tanzania. Herbal medicines have no regulatory status and are chiefly used for self medication purposes. No claims may be made about herbal medicines by law. There is no national pharmacopoeia, nor are there national monographs; furthermore, none are in development and nothing is used in their places.

There are no manufacturing requirements; safety assessment requirements are limited to traditional use without demonstrated harmful effects; however, no control mechanism guarantees this requirement. There is no registration system for herbal medicines, nor are herbal medicines included on the essential drug list. A post marketing surveillance system is being planned. There are no restrictions on the sale of herbal medicines in the United Republic of Tanzania.

Zambia

In the Republic of Zambia, the national policy on TM/CAM is part of the National Drug Policy, approved in 1997. National laws and regulations and a national programme on TM/CAM are being planned. The national office on TM/CAM is split between a desk for traditional medicine practices and a component of the National Drug Policy Analysis office on traditional and herbal medicines. An expert committee and national research institutes on TM/CAM are being planned.

While Zambia does not currently regulate herbal medicines, a bill has been proposed to do so; as the bill has not yet been passed, there is no regulatory status for herbal medicines at present. Herbal medicines are sold with claims, including medical, health nutrient content and structure/function claims; however, as the regulations are still pending, these are not yet legally recognized. There is no national pharmacopoeia and there are no national monographs in existence or in preparation. There are no manufacturing or safety assessment regulatory requirements as yet.

Likewise, there is not yet a registration system for herbal medicines, nor are herbal medicines included on the essential drug list. There are currently no plans to establish a post marketing surveillance system for herbal medicines. There are no restrictions on the sale of herbal medicines in Zambia.

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