National Policy on Traditional Medicine and Regulation of Herbal Medicines - Report of a WHO Global Survey
(2005; 168 pages) Voir le document au format PDF
Table des matières
Afficher le documentAcknowledgements
Afficher le documentExecutive summary
Afficher le documentAcronyms, abbreviations and definitions
Afficher le documentWHO Regions
Ouvrir ce répertoire et afficher son contenu1. Introduction
Ouvrir ce répertoire et afficher son contenu2. National policy on traditional medicine and complementary/alternative medicine
Ouvrir ce répertoire et afficher son contenu3. The regulatory situation of herbal medicines
Ouvrir ce répertoire et afficher son contenu4. Member States, WHO and herbal medicines
Fermer ce répertoire5. Country summaries
Afficher le document5.1 WHO African Region
Afficher le document5.2 WHO Region of the Americas
Afficher le document5.3 WHO Eastern Mediterranean Region
Afficher le document5.4 WHO European Region
Afficher le document5.5 WHO South-East Asia Region
Afficher le document5.6 WHO Western Pacific Region
Afficher le documentReferences
Afficher le documentAnnex 1. Text of survey instrument
 

5.6 WHO Western Pacific Region

Countries that responded to the survey: Western Pacific Region

Twenty-one of the 27 countries of the WHO Western Pacific Region responded to the Global Survey. Table 9 summarizes the development of national policy and regulation of TM/CAM and herbal medicines in the Western Pacific Region, 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 regional percentage figure is a percentage of the total number of WHO Member States in that region. The survey response figures represent all of the responding countries. The survey response figures represent all the responding countries, either in the region or globally, as indicated.

Table 9. WHO Western Pacific Region: positive responses

 

Member States in the Western Pacific Region responding positively with the following

Regional survey % that responded positively
(22)

Global survey % that responded positively
(141)

National policy on TM/CAM

10

45%

32%

Law or regulation on TM/CAM

9

41%

38%

National programme on TM/CAM

7

32%

28%

National office for TM/CAM

13

59%

53%

Expert committee on TM/CAM

9

41%

43%

National research institute on TM, CAM or herbal medicines

8

36%

41%

Law or regulation on herbal medicines

12

55%

65%

Registration of herbal medicines

11

50%

61%

The countries of the region demonstrate a high level of political commitment to TM/CAM policy and research, which is similar to the total survey response percentages. Almost one third of all the countries responding to the survey have each of the different forms of policy and regulation for TM/CAM and herbal medicines.

Australia

In Australia, the national policy on TM/CAM was issued in 1999. Regulations on TM/CAM in the form of the Therapeutic Goods Act were issued in 1989. The national programme and national office on TM/CAM, the Office of Complementary Medicines, was established in 1999; the office is administered by the Ministry of Health. In 1997, the Complementary Medicines Evaluation Committee was established as the expert committee. No national research institutes have yet been established for TM, CAM or herbal medicines.

In 1989, Australia began regulating herbal medicines by means of the Therapeutic Goods Act, which contains partly the same regulations as those issued for conventional medicines. Herbal medicines are regulated as over the counter medicines for self medication; the specific categories are “registered goods” and “listed goods” and form part of the Australian Register of Therapeutic Goods. Medical, health, nutrient content and structure/function claims may be made for herbal medicines by law.

In place of a national pharmacopoeia, the British pharmacopoeia is used, and is considered legally binding in those cases when a herbal medicine is listed in the pharmacopoeia. A number of monographs are used in place of national ones; however, they are not considered legally binding.

Regulatory requirements for herbal medicines include adherence to information in pharmacopoeias and monographs and the same GMP rules as those used for conventional pharmaceuticals. Implementation of these requirements is ensured through GMP licensing for finished goods manufacturers. Safety requirements for herbal medicines include 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. Compliance with these requirements is ensured through “compositional guidelines” for approved complementary medicine substances that describe the identity tests and limits for contaminants and residues, although these are not legally binding on manufacturers. Other control mechanisms include post market reviews, evaluation of toxicological data on new proposed herbal substances and history of use data.

There are 1 500 herbal medicines registered in Australia; none is included on the national essential drug list. The post marketing surveillance system has included adverse effect monitoring since 1970. In Australia, herbal medicines are sold in pharmacies as over the counter drugs, in special outlets, by licensed practitioners and without restriction.

Cambodia

In the Kingdom of Cambodia, the national policy on TM/CAM was issued in 1996 and regulations were issued in 1998. There is currently no national programme, and no information available about any plans to issue one. The national office was established in 1982 under the direction of the Ministry of Health. The establishment of an expert committee is currently being planned. The National Center of Traditional Medicine has established a committee with 11 members (Committee for Researching Traditional Medicine), and submitted the proposal (No. 023 MCSVB dated 21 March 2003) to the Ministry of Health, but it has not yet been formally adopted. There are no national research institutes on TM, CAM or herbal medicines.

Regulation of herbal medicines in Cambodia was introduced in 1998. Herbal medicines are regulated as over the counter medicines and for self medication only. By law, no claims may be made about herbal medicines.

No national pharmacopoeia exists, and one is not currently being prepared. National monographs are found in Cambodia’s medicinal plants, Vol. 1, approved by the Ministry of Health in 1996, and Cambodia’s medicinal plants, Vol. 2, approved in 1997, and in Your medicines in your garden, which was approved in 2000. Vol. 3 of Cambodia’s medicinal plants is currently in development. No information is available about the legal status of these monographs. The regulatory requirements for manufacturing or safety assessment, and the control mechanisms established to ensure compliance, come under the Department of Drugs and Food.

There are currently 48 registered herbal medicines; however, none of them are included on a national essential drug list. The regulation of herbal medicines, registration and licence of herbal medicines currently comes under the Department of Drugs and Food. No information is available about post marketing surveillance or adverse effect monitoring. Herbal medicines in Cambodia are sold in pharmacies as over the counter medicines, in special outlets, by licensed practitioners and without restriction.

China

In the People’s Republic of China, the national policy on TM/CAM was issued in 1949 and regulations were issued in 1963. The national programme was issued in 1954. The national office was established in 1949 under the Ministry of Health, but in 1998, the State Drug Administration became responsible for regulatory issues relating to traditional medicine. It is independent of the Ministry of Health. The expert committee on TM/CAM was established in 1963. National research institutes on TM, CAM and herbal medicines have been established, but the dates of establishment are not available.

The national regulations on herbal medicine were issued in 1963 in the same laws as for conventional pharmaceuticals. Herbal medicines are regulated as prescription and over the counter medicines, self medication, dietary supplements, health foods and functional foods and as a separate regulatory category. By law, medical, health and nutrient content claims may be made.

The Chinese pharmacopoeia was first published in 1963, and is considered to be legally binding; it contains 992 national herbal monographs. Regulatory requirements for herbal medicines include adherence to information contained in pharmacopoeias and monographs, the same GMP rules that apply to conventional pharmaceuticals and special GMP rules. No detailed information is available on the control mechanisms used for these requirements. Safety assessment requirements for herbal medicines include the requirements applying to conventional pharmaceuticals as well as special requirements of traditional use without demonstrated harmful effects and reference to documented scientific research on similar products. Detailed information about the control mechanisms used to ensure the implementation of these requirements is not available.

There are more than 9 000 registered herbal medicines; by the end of 2002, 1 242 herbal medicines had been included on the national essential drug list. The national post marketing surveillance system has included adverse effect monitoring since 1984. In China, herbal medicines are sold in pharmacies as prescription and over the counter medicines, in special outlets and by licensed practitioners.

Cook Islands

The Cook Islands do not have a national policy, laws, regulations, a national programme, a national office, an expert committee or national research institutes on TM/CAM, nor are there currently any plans to establish these.

There are no regulations on herbal medicines, nor do herbal medicines have any regulatory status. No claims may be made by law. No national pharmacopoeia or national monographs exist or are in development. There are no regulatory requirements for manufacturing or safety. No registration system exists; nor are herbal medicines included on a national essential drug list. There is no post marketing surveillance system for herbal medicines. There are no restrictions on the sale of herbal medicines.

Fiji

In the Republic of Fiji, there is no national policy, law or regulation or national programme for TM/CAM: however, there are plans to establish a national policy and a national programme. There is a TM/CAM national office which is administered under the Ministry of Health. Currently, there is no expert committee or national research institute for the study of TM/CAM or herbal medicines.

Fiji does not regulate herbal medicines, and herbal medicines are not sold with claims. Neither a national pharmacopoeia nor a national herbal monograph exist, and neither is in the process of being prepared. There is no information about the regulatory requirements for the manufacture of herbal medicines. The safety requirement is the special requirement of traditional use without demonstrated harmful effects. There is no information available regarding the registration system for herbal medicines: however, it was reported that no herbal medicines are included on the national essential drug list. There is also no information about any post marketing surveillance system for herbal medicines. In the Republic of Fiji, there are no restrictions on the sale of herbal products.

Japan

In Japan, no information is available on the existence of a national policy on TM/CAM. National laws and regulations on TM/CAM were issued in 1950 in the Pharmaceutical Affairs Law. No national programme on TM/CAM has been issued, and no programme is in development. No information is available about the establishment of a national office or a national expert committee. The National Institute of Health Sciences conducts research on herbal medicines; it was established in 1874.

National herbal regulations on herbal medicines in Japan were issued in 1960 in the revised Pharmaceutical Affairs Law; these regulations are the same as those for conventional pharmaceuticals. Herbal medicines are regulated as prescription and over the counter medicines, dietary supplements (called “health foods”) and functional foods. By law, medical, nutrient content and structure/function claims may be made for herbal medicines.

The Japanese pharmacopoeia was last published in 2001, and is legally binding. No national monographs have been issued, and no others are used in their place. Regulatory requirements for manufacturing are the same GMP rules that apply to conventional pharmaceuticals; these requirements are part of the following regulations: Pharmaceutical Affairs Law, Regulations for Manufacturing Control and Quality Control of Drugs and Quasi Drugs and Regulations for Buildings and Facilities for Pharmacies. The control mechanisms used to ensure the implementation of these requirements are the same as those used for conventional pharmaceuticals; however, details are not available. The regulatory requirements for safety are the same requirements that apply to conventional pharmaceuticals. To ensure the implementation of these requirements, the same rules of approval review, GMP and post marketing surveillance are used for herbal medicines as for conventional pharmaceuticals.

There is an approval system rather than a registration system; at least 1 469 herbal medicines have been approved. No information is available on a national essential drug list, or the inclusion of herbal medicines on it. The post marketing surveillance system has included adverse effect monitoring since 1993. In Japan, herbal medicines are sold in pharmacies as prescription and over the counter medicines.

Kiribati

No information is available about the existence of plans to issue a national policy on TM/CAM in Kiribati. Laws and regulations are being developed. There is a national programme. The national office of TM/CAM is the Maurin Kiribati Traditional Healers Federation. The national expert committee on TM/CAM was established in 1995. There are no national research institutes on TM/CAM or herbal medicines.

There is currently no regulation of herbal medicine in Kiribati; herbal medicines have no regulatory status and no claims may be made by law. Neither a national pharmacopoeia nor national monographs are in existence or in development.

There are no regulatory requirements for manufacturing or safety. There is no registration system, nor are herbal medicines included on a national essential drug list. A post marketing surveillance system is currently being developed. There are no restrictions on the sale of herbal medicines.

Lao People’s Democratic Republic

In the Lao People’s Democratic Republic, the national policy on TM/CAM was included in the National Drug Policy issued in 1998. Regulations were also issued in that year. The national programme on TM/CAM was issued in 2000. The Traditional Medicine Research Centre is the national office of TM/CAM, and is administered by the Ministry of Health; it was established in 1976. There is no expert committee on TM/CAM issues. National research institutes on traditional medicine and herbal medicines were established in 1996 and 1976, respectively.

Regulations on herbal medicine in the Lao People’s Democratic Republic were issued in 2002; they are separate from those issued for conventional pharmaceuticals. Herbal medicines are regulated as over the counter medicines. By law, no claims may be made. A national pharmacopoeia is neither in existence nor in development. National monographs on herbal medicines are found in Medicinal plants of ASEAN; these 10 herbal monographs are considered to be legally binding.

The regulatory requirements for herbal medicines are the same GMP rules used for conventional pharmaceuticals; however, no information is available on any kind of control mechanisms for these requirements. Safety requirements are also the same requirements as for conventional pharmaceuticals; no control mechanism exists to guarantee these requirements for herbal medicines.

There is a registration system in the Lao People’s Democratic Republic; however, the number of registered herbal medicines is not available. Thirty herbal medicines were included on the national essential drug list that was issued in 2002. A post marketing surveillance system is currently being planned. In the Lao People’s Democratic Republic, herbal medicines are sold in pharmacies as over the counter medicines and by licensed practitioners.

Malaysia

Malaysia has a national policy on TM/CAM, which was launched in the year 2001. The registration and licensing of TM/CAM is legislated through the Control of Drugs and Cosmetics Regulations 1984. A national programme was established in 2001 along with the policy. The Ministry of Health has recently set up a division for TM/CAM. Several expert committees on TM/CAM have been established to look into specific areas of TM/CAM. A Herbal Medicine Research Centre has also been set up under the Institute for Medical Research.

Regulations for traditional medicines, including herbal medicines and dietary supplements formed part of the Control of Drugs and Cosmetics Regulation in 1984. Traditional medicines are allowed to be sold as over the counter medicines. Limited health claims may also be made.

Malaysia does not have any national pharmacopoeia. However, international pharmacopoeias such as The Chinese pharmacopoeia and the Pharmacopoeia of India are used as references, but are not considered legally binding. Malaysia published the first Malaysian herbal monograph in 1999, but this is also not considered to be legally binding.

Traditional manufacturers are required to adhere to the GMP requirements for traditional products, a major part of which has been adapted from the GMP guidelines for pharmaceuticals. Compliance with these requirements is ensured through routine inspection, GMP certification and licensing of manufacturers. Safety requirements for herbal medicines include evidence of traditional use without demonstrated harmful effects, compliance with the limits set for heavy metals (mercury, arsenic, lead), testing for microbial and fungal contamination, other physicochemical tests and screening for adulterants.

As of December 2003, the Drug Control Authority (DCA) has registered approximately 12 000 traditional medicines, including herbal products. However, none of these products are included on the national essential drug list. The post marketing surveillance programme was introduced for pharmaceuticals in 1987 and was extended to cover traditional medicines in 1997. Adverse drug reaction monitoring of traditional medicines, market sampling and investigation of product complaints have since been included in the programme. In Malaysia, herbal medicines are sold in pharmacies as over the counter drugs without any restrictions.

Market sales estimates for imported and locally made medicinal products are currently not available. At the moment, there are no dedicated tariff codes for traditional medicines. However, data have been published for the domestic market in 1999, which gave a value for herbal remedies of 2 billion Malaysian ringgit (US$ 530.5 million), flavours and fragrances 1.60 billion ringgit (US$ 424.4 million), pharmaceuticals/ nutraceuticals 950 million ringgit (US$ 252.0 million) which, added together, gives a total value of 4.55 billion ringgit (US$ 1.2 billion).

Micronesia (Federated States of)

In the Federated States of Micronesia, while there are currently no plans to establish a national policy on TM/CAM, legislation stipulates that no law may be passed against the use of traditional medicine. There are no laws, regulations or national programmes on TM/CAM, nor are there currently any in development. There is no national office, national expert committee or national research institute on TM, CAM or herbal medicines.

There are no regulations on herbal medicines; herbal medicines are classified as prescription and over the counter medicines, and as a separate category. Herbal medicines are sold with structure/function claims. No national pharmacopoeia or national herbal monographs exist or are in development. There are no regulatory requirements for manufacturing or safety. There is no registration system for herbal medicines, nor are they included on a national essential drug list. There is no post marketing surveillance system for herbal medicines. There are no restrictions on the sale of herbal medicines, which are sold when traditional treatment is provided.

Mongolia

In 1999, Mongolia issued its national policy on TM/CAM in the “State Policy for Development of Mongolian Traditional Medicine”. No national laws or regulations specifically for TM/CAM have been issued or are in development; however, all health related aspects are regulated under the health and drug laws. There have been two national programmes on traditional medicine, 1992 96 and 1997 2000. In 1998, the Traditional Medical Science Technology and Production Corporation was established; it is administered by the Ministry of Health. The national expert committee was established in 1991, and is called the Professional Committee for Traditional Medicine. In 1961, the Institute for Natural Compounds of the Mongolian Academy of Sciences was established and later was transformed into the Institute of Folk Medicine, and finally became the Traditional Medical Science, Technology and Production Corporation in 1998. It serves as the national research institute for traditional medicine.

Regulations on herbal medicines were issued in 1998 and 2001; the laws are the same for herbal medicines as for conventional pharmaceuticals. Herbal medicines are regulated as prescription and over the counter medicines by the Health Minister’s order No. 169 of 2001. By law, herbal medicines may be sold with medical, health and nutrient claims.

In place of a national pharmacopoeia, many reliable resources are used, including the Chinese pharmacopoeia, State pharmacopoeia of the USSR and Indian pharmacopoeia, but they are not considered legally binding. National herbal monographs are found in the Manual of traditional medicine raw materials and prescriptions control (2003); the four herbal monographs it contains are considered legally binding.

The regulatory requirements for herbal medicine manufacture are the same GMP rules that apply to conventional pharmaceuticals. Implementation of the requirements is ensured by the State Professional Inspection Agency, which inspects manufacturing processes. The regulatory requirements for safety are the same requirements as those for conventional pharmaceuticals. Compliance with these requirements is ensured by the State Professional Inspection Agency and adverse reaction monitoring by the Drug Council.

There are 22 registered herbal medicines in Mongolia; however, none are included on the essential drug list. The national post marketing surveillance system has included adverse effect monitoring since 1998. Herbal medicines are sold in pharmacies as prescription and over the counter medicines as well as without restriction. Data on national annual sales of herbal medicines were provided for the period 2000 to 2002. In 2000, sales of herbal medicines had a value of 32.4 million tugrik (US$ 27 835). In 2001, sales reached 44.2 million tugrik (US$ 37 973). In 2002, sales dropped slightly to 40.2 million tugrik (US$ 34 536).

Nauru

In the Republic of Nauru, a national policy, laws, regulations and a national programme on TM/CAM are being established. There is a national office administered by the Ministry of Health. No expert committee has been established and there are no national research institutes on TM, CAM or herbal medicines.

There is no regulation of herbal medicines; they are classified for self medication only. No claims may be made by law. No national pharmacopoeia exists, but one is being developed. The WHO monographs are used while the pharmacopoeia is being developed. There are no national herbal monographs, nor are there plans to develop any.

There is no information about the existence of manufacturing requirements; there are no safety requirements for herbal medicine. Likewise, there is no registration system or inclusion of herbal medicines on a national essential drug list. A post marketing surveillance system is being planned. There are no restrictions on the sale of herbal medicines in Nauru.

New Zealand

In New Zealand, while there is no national policy on TM/CAM currently, such a policy is under consideration. No exclusive laws or regulations on TM/CAM have yet been established; however, several are in development. There is no national programme, nor are there currently plans to issue one. There is no national office for TM/CAM; however, plans for an office of complementary medicine are being discussed. The Ministerial Advisory Committee on Complementary and Alternative Health was established in 2001. No national research institutes on TM/CAM or herbal medicines have been established.

Herbal medicines are regulated under the Medicines Act of 1981, which also regulates conventional pharmaceuticals. Many herbal medicines are regulated under the Dietary Supplements Act of 1985. Herbal medicines are regulated as over the counter medicines, dietary supplements and as a separate regulatory category. Herbal medicines classified as extemporaneously prepared herbal medicines are exempt from regulation. Medical and health claims may be made only about those herbal medicines approved under the Medicines Act by law.

There is neither a national pharmacopoeia nor national herbal monographs, and none are being prepared. The same regulatory requirements apply to the manufacture of herbal medicines as apply to conventional pharmaceuticals. Special GMP rules apply to the manufacture of dietary supplements, but they are strictly voluntary. Implementation of these requirements is ensured, when mandatory, by auditing and licensing by the regulatory agency Medsafe. Safety requirements only apply to those herbal medicines not classified as dietary supplements; they are the same that apply to conventional pharmaceuticals. For the herbal medicines that are supplied commercially, implementation of safety requirements is ensured by a pre market evaluation and approval process.

There is a registration system in New Zealand, which is used only for products sold commercially and not regulated as dietary supplements; the total number of registered herbal medicines is not available. No herbal medicines are included on the national essential drug list. As part of the post marketing surveillance system, there is adverse effect monitoring for both conventional pharmaceuticals and herbal medicines. Herbal medicines in New Zealand are sold in pharmacies as prescription and over the counter medicines, in special outlets and without restriction. In 2000, sales of complementary medicines and other health care products were estimated at 70-80 million New Zealand dollars (US$ 43-49 million).

Niue

In the Republic of Niue, a national policy on TM/CAM is currently being developed. Laws, regulations and national programmes have not been adopted, nor are they in development. There is no national office. The national expert committee was established in 2001. There are no national research institutes.

There are no national laws or regulations on herbal medicines; there is no regulatory status for herbal medicines. Herbal medicines are not sold with claims. There is neither a national pharmacopoeia nor national herbal monographs, nor are there currently plans to develop these. There are no regulatory requirements for manufacturing or safety. There is no national registration system; no herbal medicines are included on a national essential drug list. There is no post marketing surveillance system for herbal medicines. Herbal medicines are not sold in Niue.

Papua New Guinea

In Papua New Guinea, a national policy, laws and regulations on TM/CAM are currently in development. The national programme was issued in 2001 as part of the National Health Plan, 2001-10. A national office is currently being established. The national expert committee was established in 2001. No national research institutes have yet been established for TM/CAM or herbal medicines.

No national regulations on herbal medicines have been issued. Herbal medicines have no regulatory status, and by law no claims may be made. No national pharmacopoeia exists, none is in the process of development and nothing else is used in its place. No national herbal monographs have been issued or are in the process of development.

There are no regulatory requirements for manufacturing in Papua New Guinea; however, these requirements are being developed. No safety regulatory requirements have yet been established. There is no registration system for herbal medicines, and herbal medicines are not included on a national essential drug list. There is currently no national post marketing surveillance system for herbal medicines. Herbal medicines are sold without restriction.

Philippines

In the Republic of the Philippines, the national policy on TM/CAM was issued in 1997. No laws or regulations have yet been issued. There is no information available on the existence of a national programme on TM/CAM. The national office, the Philippine Institute of Traditional and Alternative Care, was founded in 1997. It is administered by the Department of Health. There is no national expert committee on TM/CAM. The National Integrated Research Programme on Medicinal Plants of the Philippine Council of Health Research and Development serves as the national research institute on herbal medicines.

The regulations on herbal medicines were issued in 1984; these regulations are separate from those for conventional pharmaceuticals. Herbal medicines are regulated as over the counter medicines. By law, medical claims may be made for herbal medicines with supporting scientific proof.

Pending the development of the national pharmacopoeia, the United States pharmacopoeia, the Japanese pharmacopoeia and the ESCOP monographs are used and are considered to be legally binding. Pending the development of national herbal monographs, herbal monographs from a number of foreign pharmacopoeias are used; however, they are not legally binding.

Manufacturing requirements for herbal medicines are the same as the GMP rules for conventional pharmaceuticals. A control mechanism exists to ensure implementation of these requirements; however, specific details are not available. Safety requirements include the same as those required for conventional pharmaceuticals as well as the special requirement of traditional use without demonstrated harmful effects. To ensure compliance with these requirements, preclinical and clinical trials are required.

The Philippines has a registration system for herbal medicines; however, the number of registered herbal medicines is not available. Four herbal medicines are included on the national essential drug list for 2000. The post marketing surveillance system includes adverse effect monitoring for herbal medicines, using the same system as for conventional pharmaceuticals. In the Philippines, herbal medicines are sold in pharmacies as over the counter medicines and in special outlets. National sales of herbal medicines for January to May 2002 had a value of 11 468 500 Philippine pesos (US$ 208 024).

Republic of Korea

The national policy of TM/CAM in the Republic of Korea was issued in 1993; in the same year, laws, regulations and a national programme were also issued. The Bureau of Oriental Medicine within the Ministry of Health and Welfare was also established in 1993. Currently, there is no expert committee on TM/CAM. National research institutes on traditional medicine and herbal medicines were established in 1994.

Herbal medicine regulations were first issued in 1986 and were amended in 1994. The regulations on herbal medicine are part of the Pharmaceutical Affairs Law that governs conventional pharmaceuticals. Herbal medicines are regulated as prescription and over the counter medicines. By law, medical, health, nutrient content and structure/function claims may be made for herbal medicines.

The Korea pharmacopoeia was issued in 1959, and is considered to be legally binding. No national herbal monographs are currently in development, and no others are used in their place.

Regulatory requirements for manufacturing of herbal medicines in the Republic of Korea are limited to adherence to the information in pharmacopoeias and monographs; no control mechanisms exist for this requirement. Safety requirements are limited to traditional use without demonstrated harmful effects; again, there are no control mechanisms for this safety requirement.

There are about 4 000 registered herbal medicines in the Republic of Korea; 515 herbal medicines are included on the national essential drug list issued in 1959. A post marketing surveillance system for herbal medicines is being planned. In the Republic of Korea, herbal medicines are sold in pharmacies as over the counter medicines, in special outlets and by licensed practitioners. Annual market sales data were provided by the Republic of Korea for the period 1998-2001. Sales in 1998 were US$ 279 million, in 1999, US$271 million and in 2001, US$ 291 million.

Singapore

In the Republic of Singapore, the national policy on TM/CAM was issued in 1995. In 2000, the Traditional Chinese Medicine Practitioners Act established regulations on TM/CAM. There is no national programme, nor are there currently any plans to issue one. The TM/CAM national office was established in 1995 and is administered by the Ministry of Health. The expert committee was established in 1996. There are currently no national institutes on TM/CAM or herbal medicines.

There are national regulations on herbal medicines in Singapore. A subgroup of herbal remedies is Chinese proprietary medicines (CPM), which are traditional Chinese herbal medicines in finished dosage forms (e.g. tablets, capsules). In 1998, Singapore issued regulations on Chinese proprietary medicines, which are similar to those regulating conventional pharmaceuticals. Herbal medicines are regulated as over the counter medicines. By law, medical, health, nutrient content and structure/function claims may be made for herbal remedies, except for 19 serious diseases or medical conditions for which claims are prohibited.

Singapore does not possess a national pharmacopoeia or national herbal monographs. Reputable references, including the Chinese pharmacopoeia, are used, but are not considered to be legally binding.

Regulatory requirements for Chinese proprietary medicines are the same GMP rules used for conventional pharmaceuticals. Control mechanisms for CPM requirements include marketing authorization requirements and licensing of manufacturers. Regulatory requirements for safety include traditional use without demonstrated harmful effects, toxic heavy metal content and microbial content testing, and absence of prohibited ingredients. Licensing of dealers and product approval are required for every CPM product imported, manufactured or assembled.

There are currently no registration requirements for herbal medicines and none are included on a national essential drug list; however, a listing system has been established for CPM products. The post marketing surveillance system for all herbal medicines has included adverse effect monitoring since 1993. There are no restrictions on the sale of herbal medicines, as long as they comply with the national regulations.

Solomon Islands

In the Solomon Islands, a national policy on TM/CAM was issued in 1994. Laws, regulation and a national programme on TM/CAM have not been issued, nor are they in development. There is also no national office, expert committee or national research institute.

There are no national laws or regulations on herbal medicines; herbal medicines are classified for self medication only. Herbal medicines are not sold with claims. There is neither a national pharmacopoeia nor national herbal monographs, nor are there currently plans to develop these.

Regulatory requirements for manufacturing include adherence to information in pharmacopoeias and monographs and the same rules of GMP required for conventional pharmaceuticals. There are no control mechanisms for these requirements. Safety requirements are limited to traditional use without demonstrated harmful effects. Again, no control mechanisms exist for this requirement.

There is no national registration system; no herbal medicines are included on the national essential drug list. A post marketing surveillance system for herbal medicines is in the process of being developed. Herbal medicines are sold without restriction in the Solomon Islands.

Tuvalu

In Tuvalu, no national policy, laws, regulations or national programme on TM/CAM have been issued, nor are they in development. There is also no national office, expert committee or national research institute.

There are no national laws or regulations on herbal medicines; herbal medicines are classified in a separate category. Herbal medicines are not sold with claims. There is neither a national pharmacopoeia nor national herbal monographs, nor are there currently plans to develop these. There are no regulatory requirements for manufacturing or safety. There is no national registration system; no herbal medicines are included on a national essential drug list. There is no post marketing surveillance system for herbal medicines, nor is one being developed. Herbal medicines in Tuvalu are sold directly by traditional healers.

Vanuatu

In Vanuatu, no national policy, laws, regulations or national programmes have been issued. A national policy is being developed. There is also no national office, expert committee or national research institute.

There are no national laws or regulations on herbal medicines; herbal medicines are classified as a separate category. Herbal medicines are not sold with claims. There is neither a national pharmacopoeia nor national herbal monographs; there are currently no plans to develop them.

Regulatory requirements for manufacturing are the same GMP rules as for conventional pharmaceuticals. No information is available about safety requirements. There is no national registration system; no herbal medicines are included on an essential drug list. There is no post marketing surveillance system for herbal medicines, nor is one being developed. Herbal medicines in Vanuatu are sold in special outlets.

Viet Nam

In the Socialist Republic of Viet Nam, a national policy on TM/CAM is currently being developed. Laws and regulations were issued in 1989 and a national programme was issued in 1986. The Department of Traditional Medicine is administered by the Ministry of Health, and was established in 1957. There is currently no expert committee. In 1957, the Vietnamese Institute of Traditional Medicine was established, and in 1976 the Hochiminh Institute of Traditional Medicine and Pharmacy was founded.

National laws and regulations on herbal medicines were issued in 1989, separately from the laws governing conventional pharmaceuticals. Herbal medicines are regulated as prescription and over the counter medicines. By law, medical, health and nutrient content claims may be made.

The Vietnam pharmacopoeia is legally binding, as are the national herbal monographs found in Vietnam medicinal plants.

Regulatory requirements for manufacturing include adherence to information in pharmacopoeias and monographs and the same GMP rules used for conventional pharmaceuticals. Implementation of these requirements is ensured by inspection and visits to manufacturing establishments. Safety requirements for herbal medicines include traditional use without demonstrated harmful effects and reference to documented scientific research on similar products. Classical or traditional remedies are used and promoted without the need to demonstrate the safety of the product. New remedies, indications or uses for herbal medicines must be accompanied by records of clinical trials. Implementation of these requirements is ensured by the registration system.

There are currently 1 573 registered herbal medicines in Viet Nam; 267 herbal medicines are included on the national essential medicines list of 1996. The post marketing surveillance system includes monitoring of adverse effects for herbal medicines. In Viet Nam, herbal medicines are sold in pharmacies as prescription and over the counter medicines, in special outlets and by licensed practitioners.

 

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