Date:

Country:

Name of Investigator:

Title of Investigator:

Address:

Telephone:

Fax:

E-mail:

1. Traditional/Complementary/Alternative Medicine
(TM/CAM)

Useful explanations:

Traditional Medicine (TM): TM is the sum total of the knowledge, skills, and practices based on the theories, beliefs and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in prevention, diagnosis, improvement or treatment of physical and mental illnesses.

Complementary and Alternative Medicine (CAM): The term CAM often refers to a broad set of health-care practices that are not part of a country’s own tradition and are not integrated into the dominant health-care system. Other terms sometimes used to describe these health-care practices include ‘natural medicine’, ‘non-conventional medicine’ and ‘holistic medicine’.

Source: General guidelines for methodologies on research and evaluation of traditional medicine, WHO/EDM/TRM/2000.1.

Policy

Useful explanations:

National policy on TM/CAM: A national policy on TM/CAM could include some of the following key elements: a definition of TM/CAM, provision for the creation of laws and regulations, consideration of intellectual property issues, etc. The policy could further contain main strategies proposed by the government for achieving the objectives of the policy.

Source: WHO traditional medicine strategy 2002-2005 (in press).

Law & Regulation

Useful explanations:

Law on TM/CAM: A law is the first stage of legislative procedures; it is a rule of conduct imposed by the authority. A law establishes the legal conditions under which TM/CAM should be organized in line with a national TM/CAM policy, or other relevant policies. The law could cover different areas in the TM/CAM field, for instance education of professionals, licensing of practitioners and manufacturers, the manufacture of products used in TM/CAM, sales practice, etc. Both public and private sector could be taken into account.

Regulation on TM/CAM: Regulations form the second stage of legislative procedures, specifically designed to provide the legal machinery to achieve the administrative and technical goals of a law. Many activities in the field of TM/CAM could be covered by regulations, such as a description of obligations and responsibilities of licensed practitioners, the penal sanctions if these are not respected, the obligation of manufacturers of TM/CAM products, etc.

Source: Indicators for monitoring national drug policies, 2^nd ed., WHO/EDM/PAR/99.3.

National Programme

Useful explanations:

National programme on TM/CAM: A national programme on TM/CAM is defined here as any programme performed on local or national level, by the ministry of health, by other ministries, or by local bodies, whose mandate is to take concrete action in order to achieve objectives in line with the national policy or legislation.

Ministry of Health

Other, namely

__________________

If no, is the establishment of such an office being planned?

YES NO

National Research Institute

Useful explanations:

A national research institute for TM/CAM or for herbal medicine is a research institute that performs research on TM/CAM or herbal medicine and is fully or partially funded by the government.

YEAR OF ESTABLISHMENT

TM?

YES NO

_____________

CAM?

YES NO

_____________

Herbal medicines?*

YES NO

_____________

2. The Regulatory Situation of Herbal Medicines

Useful explanations:

Herbal Medicines: Herbal medicines are here defined as plant-derived material or preparations with therapeutic or other human health benefits, which contain either raw or processed ingredients from one or more plants. In some traditions material of inorganic or animal origin may also be present¹.

Conventional Pharmaceuticals: Conventional pharmaceuticals are here defined as medicinal drugs used in conventional systems of medicine with the intention to treat or prevent disease or to restore, correct or modify physiological function².

Source: 1. General guidelines for methodologies on research and evaluation of traditional medicine, WHO/EDM/TRM/2000.1. 2. Dorlands illustrated medical dictionary, 29^th edition, 2000.

Law & Regulation

Useful explanations:

For explanation of law and regulation, please see textbox above.

Please choose type of law or regulation:

Same law or regulation as for conventional pharmaceuticals

Separate law or regulation for herbal medicines

The law or regulation for herbal medicines is partly the same as for conventional pharmaceuticals

Regulatory Status

Useful explanations:

Prescription Medicines: Medicines/drugs that can only be purchased with a prescription, a physician’s order¹.

Over the Counter Medicines: Medicines/drugs that can be purchased without a prescription from a physician¹.

Self-medication only: Medicines/drugs only allowed for self-medication purposes.

Herbal Medicines: see description in textbox above.

Dietary Supplements: A dietary supplement could be intended to supplement the diet that bears or contains for instance a vitamin, a mineral, an herb or other botanical, an amino acid. A dietary substance could be intended to supplement the diet by increasing the total daily intake of a concentrate, metabolite, constituent, extract, or combination of these ingredients².

Health Food: Health foods could be products that are presented with specific health claims and therefore regulated differently than other foods³.

Functional Food: Like health foods, functional foods could be products presented with specific health claims and therefore regulated differently than other foods³.

Other: This group includes products that are classified differently than the above-mentioned categories.

Since many countries define herbal medicines differently, please notice that “herbal medicines” in this questionnaire refer to the WHO definition on page 1.

Source: 1. Dorlands illustrated medical dictionary, 29^th ed, 2000. 2. Chang J. Scientific evaluation of traditional Chinese medicine under DSHEA: a conundrum. Journal of Alternative and Complementary Medicine, 1999, 5:181-189. 3. CSPI reports: international functional foods: public health boon or 21^st century quackery Washington, D.C., International Association of Consumer Organizations, 1999 (http://www.cspinet.org/reports/functional_foods/table1.html)

Please tick all that apply.

Prescription Medicines

Over-the-counter Medicines (O.T.C.)

Self-medication only

Herbal Medicines as a separate regulatory category

Dietary Supplements

Health Food

Functional Food

Other, namely

No status

Claims

Useful explanations:

Medical claims: Medical claims are here defined as those claims specified to treat, cure or prevent a disease or restore, correct or modify physiological functions. Most often, products with medical claims have to be registered by the medical products agency before allowed into the market.¹

Health claims: Health claims are here defined as follows: “any statement, suggestion or implication in labelling or advertising that a product carries a specific health benefit, but not nutritional claims nor medicinal claims. The term health claim further includes claims that refer to nutrient function and recommended dietary practice”².

Nutrient content claims: Nutrient content claims are for instance indicating that a certain product is particularly rich or low in a nutritional component such as fibre or fat².

Structure/functional claims: These claims link a substance to an effect on a structure or function of the body³.

Source: 1. Joint Health Claims Initiative Body, www.jhci.co.uk. 2. Swedish Food Administration - www.slv.se. 3. CSPI reports: international functional foods: public health boon or 21^st century quackery? www.cspinet.org/reports/functional_foods/table1.html

Please tick all that apply.

Medical claims

Health claims

Nutrient content claims

Structure/function claim

No claims can be made according to the law

Other claims, namely

Pharmacopoeia

Useful explanations:

Pharmacopoeia: A pharmacopoeia is a formulary, especially an official one and usually one having legal force in all pharmacies of a given country, containing a description of drugs in current medical practices and noting their formulae, analytical composition if known, physical constants, main chemical properties useful in identification, and mode of preparation of compound preparations/combination products. Details may also be included of assay methods to regulate purity, content of active principle, preservation of quality and where appropriate, biological potency.

Source: Churchill medical dictionary, 1989.

If yes,

Title:_________________________
Edition number:_______________
Year of issue:__________________

Please submit a copy of the pharmacopoeia, if available in English, otherwise in original language.

If several pharmacopoeias exist for herbal products, please submit information about all.

Is the information in the pharmacopoeia legally binding?

YES NO

If no,

Is a national pharmacopoeia including herbal medicines in process

YES NO

Is any other pharmacopoeia used

YES NO

If yes,

Title:________________________
Edition number:_______________
Year of issue:_________________

Is the information in the pharmacopoeia legally binding?

YES NO

Monographs

Useful explanations:

Monographs on herbal products constitute descriptions of different herbal medicinal formulae, which can either be included in a pharmacopoeia or exist separately.

Source: WHO monographs on selected medicinal plants, Vol. 1, 1999.

If yes,

Title: ________________________
Edition number: ________________
Year of issue: __________________
Number of monographs issued: ____

Please submit a copy of the monographs, if available in English, otherwise in original language.

Is the information in the monographs legally binding?

YES NO

If no,

Are national herbal monographs in process?

YES NO

Are other monographs used?

YES NO

If yes,

Title: ________________________
Edition number: ________________
Year of issue: __________________
Number of monographs issued: ____

Is the information in the monographs legally binding?

YES NO

Manufacturing

Useful explanations:

Good Manufacturing Practice (GMP): Basic requirements of GMP include areas such as quality management, personnel, premises and equipment, documentation, production, quality control, contract manufacture and analysis, complaints and product recall and self inspection.

Source: British pharmacopoeia, 2000.

Please tick all that apply.

Adherence to information in pharmacopoeia/monographs

Same rules of Good Manufacturing Practice (GMP) as for conventional pharmaceuticals

Special GMP rules

No requirements

Others, namely

Please submit a copy of the rules, if available in English, otherwise in original language.

12b. Is implementation of the manufacturing requirements of herbal medicines ensured by any control mechanism?

YES NO

Please tick all that apply.

Same requirements as for conventional pharmaceuticals

Special requirements, namely

Traditional use without demonstrated harmful effects

Reference to documented scientific research on similar products

Other requirements, namely

No requirements

13b. Is implementation of the safety requirements for herbal medicines ensured by any control mechanism?

YES NO

14. Is there a registration system for herbal medicines?

YES NO

15. Are herbal medicines included in the national essential drug list?

YES NO

16. Is there a post-marketing surveillance system for herbal medicines?

YES NO

If yes,
Is there a national system to monitor adverse effects of herbal medicines?

YES NO

Year of establishment:

__________

If no,
Are there any plans to establish such a system?

YES NO

Please tick all that apply.

In pharmacies as prescription drugs

In pharmacies as over-the-counter drugs

In special outlets

By licensed practitioners

No restrictions for selling herbal products

Other ways, namely

HERBAL MEDICINES ANNUAL SALES

YEAR

MARKET SALES

TYPE OF DATA/ESTIMATE

YEAR

MARKET SALES

TYPE OF DATA/ESTIMATE

YEAR

MARKET SALES

TYPE OF DATA/ESTIMATE

3. The countries, WHO and Herbal Medicine

Useful explanations:

WHO wants to learn more about the needs of each Member State and the feedback from each country is therefore essential for a future successful support from WHO to the countries.

Lack of research data

Lack of expertise within the national health authorities and control agency

Lack of appropriate mechanisms for control of herbal medicines

Lack of education and training

Other, namely

Please tick options as prioritised.

MUCH NEEDED

NEEDED

NOT NEEDED

Information sharing on regulatory issues

Training workshops about national capacity to establish regulations on herbal medicine

General guidelines for research and evaluation of traditional medicine

Training workshops about national capacity building on safety monitoring of herbal medicines

Provision of databases

Arrangement of global meetings

Other, namely

As a descriptive report

As a condensed report with results presented in figures/tables

Results/analysis presented in a database