WHO’s Guidelines for the Appropriate use of Herbal Medicines.
Herbal medicines form an important part of most traditional systems of medicine in the Western Pacific Region. They play an important role particularly in primary health care.
The significant contribution made by herbal medicines to human health has led to increased popular, official and commercial interest. More and more governments are considering policies on the appropriate use of herbal medicines.
In 1989, the World Health Assembly adopted a resolution on traditional medicine and modern health care. This resolution urges Member States to introduce measures for the regulation and control of medicinal plant products.
Government policy on herbal medicines requires a clear statement on the role of herbal medicines in health care. The extent of the government’s involvement and the relationship between herbal medicine and general health services need to be clearly defined. At the same time, mechanisms need to be established to ensure the safety and quality of herbal medicines and traditional methods of care.
To support Member States that are engaged in these issues, the WHO Regional Office for the Western Pacific Region organized a Working Group on Herbal Medicines in December 1997. This meeting prepared a set of Guidelines for the appropriate use of herbal medicines.
The guidelines cover a broad range of topics in relation to herbal medicines, with particular emphasis on national policy development, regulation of practice and registration of herbal products.
In some countries, a significant percentage of the population still relies heavily on locally produced herbal medicines for their health care. It may not, therefore, be possible to implement some aspects of the guidelines immediately. A schedule could be set up so the guidelines are implemented step by step. These guidelines represent a set of generic principles which can be flexibly implemented by individual countries.
It is hoped that these guidelines will prove a useful technical, managerial and administrative tool for countries intending to initiate or continue promoting the appropriate use of herbal medicines in their health care systems.
S.T. Han, MD, Ph.D.
1.1 The role of herbal medicines
Plants have been used for health and medical purposes for several thousands of years. The number of higher plant species on earth is about 250 000. It is estimated that 35 000 to 70 000 species have, at one time or another, been used in some cultures for medicinal purposes. A majority of the world’s population in developing countries still relies on herbal medicines to meet its health needs. Herbal medicines are often used to provide first-line and basic health service, both to people living in remote areas where it is the only available health service, and to people living in poor areas where it offers the only affordable remedy. Even in areas where modern medicine is available, the interest on herbal medicines and their utilization have been increasing rapidly in recent years.
Medicinal plants are important sources for pharmaceutical manufacturing. Medicinal plants and herbal medicines account for a significant percentage of the pharmaceutical market. For example, in China, medicinal plants and their products had a 33.1% share of the pharmaceutical market in 1995. In Malaysia, the market for traditional medicine is estimated at about 1 billion Malaysia rinngit annually.
1.2 WHO’s policy on herbal medicines
The World Health Organization is fully aware of the importance of herbal medicines to many of its Member States and supports the use of medicinal plants and their products. In early 1978, the World Health Assembly, the WHO governing body, adopted a resolution on drug policies and management of medicinal plants, which recognized the importance of medicinal plants in the health care system. The World Health Assembly proposed coordinating efforts through the preparation of an inventory of medicinal plants, the development of criteria and methods for proving the safety and efficacy of medicinal plant products, and the dissemination of relevant information. In 1987, 1988 and 1989, three more resolutions were adopted covering the identification, evaluation, preparation, cultivation, utilization, regulation and conservation of medicinal plants.
Based on those resolutions, WHO’s policy on herbal medicine may be summarized as follows:
(1) WHO is fully aware of the importance of herbal medicines for the health of a large number of the population in today’s world. Herbal medicines are recognized as valuable and readily available resources, and their appropriate use is encouraged;
(2) To promote the proper use of medicinal plants, a comprehensive programme for their identification, evaluation, preparation, cultivation, recognition as valuable and readily available resources, and their appropriate use is encouraged;
(3) It is necessary to make a systematic inventory and assessment (pre-clinical and clinical) of medicinal plants; to introduce measures on the regulation of herbal medicines to ensure quality control of herbal products by using modern techniques, applying suitable standards and good manufacturing practices; and to include herbal medicines in the national standard or pharmacopoeia.
(4) As many of the plants that provide traditional and modern drugs are threatened with extinction, WHO endorses the call for international cooperation and coordination to establish programmes for the conservation of medicinal plants, to ensure that adequate quantities are available for future generations.
1.3 The need for the guidelines on appropriate use of herbal medicines
Herbal medicines, particularly those applied by traditional systems of medicine, have been used for thousands of years. Clinical experience built over many centuries provides a substantial basis for the safe and effective use of herbal medicines, not just as a main form of therapy, but as a complement to the main stream of Western medical treatment in certain diseases. In developing countries, herbal medicines are considered to be more readily available, accessible, affordable, culturally acceptable and sustainable than Western medicines. In developed countries, the popularity of herbal medicines is continuing to grow, particularly for the treatment of certain categories of disease.
Herbal medicines, however, are not necessarily always safe simply because they are natural. Some have given rise to serious adverse reactions and some contain chemicals that may produce long-term side effects such as carcinogenicity and hepatotoxicity. Herbal medicines will only benefit the health of human beings when they are used appropriately. Thus, good quality control and standardization of herbal medicines are essential. Furthermore, with the increased use of both herbal medicines and modern western pharmaceutical drugs, there is a need to monitor interactions.
With the growing popularity of herbal medicines worldwide, many countries will be interested in receiving technical support and guidance in developing a framework for the promotion, development and regulation of herbal medicines. This framework will lay a strong foundation for the future development of herbal medicines in the health care systems of individual countries.
The management of herbal medicine practices and the use of herbal medicinal plants differ from country to country and are at different stages of development. These guidelines for the appropriate use of herbal medicines, general enough to be comprehensive and yet flexible enough to be modified for each individual country’s needs, will, therefore, be helpful.
- To promote the appropriate use of herbal medicines; and
- to encourage the integration of herbal medicines into the mainstream health service delivery system.
- To provide basic principles and applicable standards for interested countries and areas in the Region to develop a national policy and programmes on herbal medicines;
- to guide interested countries and areas in the Region to develop measures for promoting the appropriate use of herbal medicines, appropriate to their own situations;
- to facilitate information exchange on the appropriate use of herbal medicines among policy-makers, researchers and drug administrators; and
- to ensure the safe and effective use of herbal medicines by practitioners and consumers.
The following terms are used as working definitions in this document:
|Characterizing compound or marker||a natural constituent of a plant part that may be used to assure the identity or quality of a plant material or preparation, but is not necessarily responsible for the plant’s biological or therapeutic activity.|
|Herbal medicines||plant-derived materials or products with therapeutic or other human health benefits which contain either raw or processed ingredients from one or more plants. In some traditions, materials of inorganic or animal origin may also be present, although for the purpose of this document, the focus will be on plant materials only.|
|Under this definition, there are three kinds of herbal medicines: raw plant materials, processed plant materials and medicinal herbal products. The definition does not apply where the active component has been identified, and either isolated or synthesized as a chemical component of a drug product.|
|Ingredient||the substance in the herbal formulation which may not be a purified chemical component.|
|Medicinal herbal products||finished, labelled pharmaceutical products in dosage forms that contain one or more of the following: powdered plant materials, extracts, purified extracts, or partially purified active substances isolated from plant materials. Medicines containing plant material combined with chemically defined active substances, including chemically defined, isolated constituents of plants, are not considered to be herbal medicines.|
|Medicinal plant||a plant which has been used for medical purposes at one time or another, and which, although not necessarily a product or available for marketing, is the original material of herbal medicines.|
|Processed plant materials||plant materials treated according to traditional procedures to improve their safety and efficacy, to facilitate their clinical use, or to make medicinal preparations.|
|Raw plant materials||fresh or dry plant materials which are marketed whole or simply cut into small pieces.|
|Therapeutic compound||a constituent which is responsible for the intervention of a plant, that results in the amelioration of the manifestations of human disease.|
|Traditional use||the use of herbal medicines by practitioners of a traditional system of medicine, where:|
|(a) the use is well-established and widely acknowledged, i.e., the use represents the accumulated experience of many practitioners over an extended period of time;|
|(b) the use of the herbal medicine, including dosage, indication, and administration route is well-established and documented; and|
|(c) the use is generally and currently regarded as safe.|
4. National policy development
A national policy is a statement of the Government. It should clearly indicate the view of the Government on the role of herbal medicines in promoting and maintaining health and the Government’s position on their development, appropriate use and relationship to the national drug policy.
4.1 Process for the development of a policy on herbal medicine
A systematic review of the current status of herbal medicine in individual countries and its role in maintaining health will be necessary for policy development.
The national health authority is the most appropriate body to take the lead in developing the national policy. It can be assisted by a national advisory committee, supported by subcommittees to advise on specific aspects, if required. Where necessary, expert opinions can be obtained from international agencies and other countries. In formulating the policy, consideration should be given to the existing health care system, socioeconomic situation, local tradition and culture. The approach should be practical.
A strategic plan should be developed as part of overall planning. Following identification of problems and benefits, priorities can be set and objectives better defined. The adoption of a strategy is very important as it may involve a choice between several approaches to address the issues. Consultation with the communities and interested parties concerned is essential.
The contents of the draft policy document should be discussed with institutions within and outside government and with the private sector before it is finalized and submitted for formal endorsement.
4.2 Issues to be included in the policy
A number of components will be important in the development of an effective policy on herbal medicine. The policy should recognise the contribution herbal medicine can make to the overall health care system of the country.
4.2.1 Recognizing the role of herbal medicine in the health care system
It is noted that herbal medicine has been used by traditional systems of medicine for a long time. Prolonged and apparently uneventful use of herbal medicine is highly suggestive of its safety and efficacy. Traditional use of herbal medicine is usually an integral part of the culture, which developed within an ethnic group before the spread of modern science. The principles of the traditional system of medicine must be respected when a policy on herbal medicine is prepared. As a general rule, traditional experience should be taken into account along with the medical, historical and ethnological background of the medicine.
4.2.2 Supporting the appropriate use of herbal medicine
The policy should address the importance of herbal medicines in the health care system by identifying the health, economic, social and other benefits of their use. The policy may need to make reference to specific strategies for promoting and incorporating the use of herbal medicines.
4.2.3 Developing appropriate human resources
To ensure the safe and effective use of herbal medicines, the training requirements of practitioners and regulators need to be addressed. This should include reference to quality training programmes for practitioners, and consideration of the educational requirements of regulatory and other personnel.
The policy should also address the education of medical practitioners, pharmacists and the community to facilitate the safe and effective use of herbal medicines as an integral part of the total health care system.
4.2.4 Establishing suitable management and regulatory measures
The needs of consumers and industry, the role of practitioners, and the responsibilities of government should be clearly established in this regard. Policies should be responsive to these identified needs and be designed to ensure they best serve the public in terms of the delivery of safe and effective herbal medicines. The policy should consider the regulatory framework necessary to oversee the manufacture, processing, storage, distribution, sale, import, export and use of these products.
4.2.5 Planning for research and development
The direction and priorities for research and development should be identified. These should take into account such matters as the nature of the country’s health care system, the economic and social situation, the availability of health and research personnel, and the degree of access to orthodox and herbal medicines. Account should also be taken of associated research activities occurring in the Region and globally.
4.2.6 Supply of herbal medicines
Where appropriate, the policy should address the need for, and mechanisms to ensure reliable supply of quality herbal medicines. These measures may include policies to manage the utilization of local natural resources, and cultivation and trading with attention to minimizing contamination.
4.2.7 Subscribing to the conservation of medicinal plants
The policy should address the need to preserve endangered species, particularly those identified as requiring conservation nationally and internationally. Practical measures for conservation may need to be identified, particularly for those plants identified as having significant therapeutic use and other benefits to the country.
4.2.8 Provisions of funds
For a national policy to be realised, the policy should identify the costs associated with any national programme and the expected sources of funding. The cost-benefit of the national herbal medicine policy and programme may need to be identified.
4.2.9 Technical cooperation among countries
The importance and benefits of cooperation with other countries, particularly on technical issues, should be recognized. Mechanisms to facilitate this cooperation should be included in the policy.
4.2.10 Monitoring and evaluation of national herbal medicine policies
A process for monitoring and evaluating of the progress and success of the policy should be an integral part of the herbal medicine policy. This will provide the basis for any adjustment to the policy as it evolves, and support for ongoing funding.
5. Development of a national programme on herbal medicines
During the forty-second World Health Assembly, Member States were urged to initiate comprehensive programmes on medicinal plants used in traditional medicine for their identification, evaluation, preparation, cultivation and conservation. The approach to the adoption and development of these programmes should take into consideration the socioeconomic situation of the country and availability of resources to support these programmes. The countries should take a phased approach taking into consideration the priorities of each country.
5.1 National management body for the herbal medicine programme
A national body of appropriate size to coordinate the development of the herbal medicine programme should be established. This body should be responsible for defining the national policy and strategy and translating them into an action plan. It should work closely with other related agencies such as the national drug policy body.
The national management body for herbal medicine should coordinate the implementation of multisectoral and interdisciplinary activities related to herbal medicine. It should also provide advice, suggestions and references to policy-makers. It should ensure that the adopted policy, strategy and action plans are translated into operational activities at different levels.
Advisory committees should be set up to provide suggestions and recommendations to the national body. A national network for implementation of the national herbal medicine programme should be established to support the work of the national body.
5.2 Use of herbal medicines in health care
In many communities and families in the Region, herbal medicine is an available, affordable, effective and culturally-acceptable health care modality. The use of herbal medicine can meet certain primary health care requirements of the people, particularly in less developed, rural and remote areas. The existing community-based traditional medicine projects in several countries have demonstrated the vital role that can be played by herbal medicine in primary health care. In more developed countries, it can complement modern pharmaceutical medicines.
The knowledge available in communities about the use of medicinal plants should be collected and collated, preferably with the participation of the communities themselves. Medicinal plants commonly used in the communities should be selected. The basic criteria in the selection of plants should be: (1) locally available; (2) useful for common health problems; and (3) availability of references on their safety and efficacy. Educational and training materials on these selected plants should be prepared and disseminated. Community health workers should be trained in the identification, collection, processing, storage and utilization of the plants. Villagers should be encouraged to plant medicinal plants in their gardens or backyards.
The herbal medicine practices should be coordinated and integrated into the country’s health care system. They can be components of health care establishments at the primary, secondary and tertiary levels or can stand alone. Countries are encouraged to be aware of recent developments in herbal medicine throughout the world and to adopt such treatments into their health care services as and when appropriate if it is beneficial to the community.
5.3 Research on herbal medicines
Although herbal medicines used by traditional systems of medicine have been tested through long historical practice, scientific research on herbal medicines will provide additional evidence of their safety and efficacy. Research will also provide data on herbal medicines to meet regulatory requirements. However, respect of the principles of the traditional system of medicine under study must be an important consideration when the research project is prepared, conducted and evaluated. The Research guidelines for evaluating the safety and efficacy of herbal medicines, prepared by the WHO Regional Office for the Western Pacific, provide suggestions and guidance on research methodology on pharmacodynamic and general pharmacological studies, toxicity investigations and clinical trials.
Efforts should be made to upgrade research capability in the field of herbal medicines. Research should initially be utilization-based and preferably include the participation of practitioners and consumers to ensure maximum support from the community.
Whenever necessary, research projects should be conducted in collaboration, involving various research agencies.
5.4 Preparation of information on medicinal plants
A monograph on medicinal plants is a technical document which provides scientific information on the safety, efficacy and quality control of medicinal plants to promote their proper use as herbal medicines. It can serve as a document for official endorsement as well as assist the appropriate use of herbal medicine. It will also facilitate information exchange among Member States.
The information contained in the monographs includes botanical features, quality control standard and test methods, major chemical constituents, clinical applications, pharmacology, posology and possible contraindications and precautions. The format of monographs for medicinal plants, prepared by a WHO collaborating centre for traditional medicine at the University of Illinois in Chicago, United States of America, could be used as a model for interested countries.
Each country should prepare informative publications from the monographs as a reference for the health care workers and the public.
5.5 Conservation of medicinal plants
The use of plants as medicines has been taken for granted on the assumption that the plants will be available on a continuing basis. However, many medicinal plants face extinction or severe genetic loss. The forty-first World Health Assembly (1988) adopted a resolution which endorsed the call for international cooperation and coordination to establish a basis for the conservation of medicinal plants to ensure that adequate quantities are available for future generations. Each individual country is encouraged to develop programmes to preserve the continuing existence of local medicinal plants and, if applicable, to introduce additional plants through appropriate processes.
Guidelines on the conservation of medicinal plants prepared by WHO, IUCN (The World Conservation Union) and WWF (World Wide Fund for Nature) should be followed by Member States when a national programme on herbal medicine is prepared.
Medicinal plants are valuable natural and genetic resources and an inventory and survey of medicinal plants should be conducted in each country regularly. A list of endangered species of medicinal plant in each country should be prepared and actions for their protection and conservation should be taken, preferably by the Government, including the establishment of seed banks.
The cultivation of plants needed for medicinal purposes should be encouraged to ensure adequate local supply. Incentive schemes could be devised to support this.
5.6 Training and education
Proper plans should be made concerning the education and training of practitioners and related health workers, and, where appropriate, examination, continuing education, and registration or licensing of the appropriate groups.
A human resource development plan should also be prepared to ensure that there will be adequate types and numbers of health care personnel to support this programme. External support and expertise may be required at various stages.
It is desirable to include knowledge on traditional and herbal medicine in the curricula for students in medical and pharmaceutical schools.
5.7 Collection and exchange of information on herbal medicines
Collection and exchange of information on herbal medicines, including the preparation of monographs on medicinal plants and evaluation of their safety, efficacy and quality, should be encouraged. For collected information, the construction of various databases is desirable to promote information exchange. Utilization of available databases and distribution of information from existing databases should be given high priority.
6. Regulation of practitioners
Herbal medicines may be used as self-medication for many conditions. However, in most cases, the use of herbal medicines needs to be guided by qualified practitioners.
The type of regulatory framework deemed appropriate for herbal medicine will thus depend on the nature of the problems identified as arising from its practice.
Regulation of practitioners who provide service to others, particularly practitioners whose practice brings economic benefit, should ensure quality of herbal medicine services and thus protect the public. The regulation of herbal medicine practitioners may also protect the qualified practitioners.
There are many regulatory options which can be adopted. These range from professional organizations imposing standards on their own members, to a recognition of these standards, either directly or indirectly, by the government, including statutory support for bodies which impose standards or formal government registration of practitioners by law.
To facilitate the process for registration of practitioners, a national examination system could be created. The examination could be organized by health authorities or an independent body under the supervision of the Government. The establishment of a national examination system will promote efforts in upgrading the training on herbal medicine and ensuring that certain standards of practice are met.
7.1 General considerations
Medicinal herbal products are prepared from material of plant origin which may be subject to contamination and deterioration, and may vary in composition and properties. This is in contrast to conventional pharmaceutical products, which are usually prepared from synthetic materials by means of reproducible manufacturing techniques and procedures. Furthermore, in the manufacture and quality control of medicinal herbal products, procedures and techniques are often used which are substantially different from those employed for conventional pharmaceutical products and from traditional methods of preparation.
The control of the starting materials, storage and processing assumes particular importance because of the complexity, variability and perishable natures of any medicinal herbal products and the number of potentially active ingredients present in small quantities. It is advisable that medicinal herbal products that may be widely used in the marketplace are adequately regulated so as to ensure quality, efficacy and safety of the products.
In recognition of the various legislative, socioeconomic and cultural contexts, the degree and form of management or regulation should be consistent with the specific circumstances of that country, yet adequate to ensure safety and quality of herbal medicines. In some countries different regulatory requirements for herbal medicines have been applied.
A regulatory system should be developed for manufacturers and distributors of medicinal herbal products at all levels including importers, exporters, wholesalers or retailers by licensing, registration or other means. The system should allow for periodic review.
7.2 Good manufacturing practices (GMP)
Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to quality standards appropriate to their intended use and as required by the marketing authority. GMP rules are directed primarily at diminishing the risks inherent in any pharmaceutical production that cannot be prevented completely through the testing of final products.
All procedures for the manufacture of herbal medicine under regulation should be in accordance with GMP. WHO Good manufacturing practices for pharmaceutical products and Good manufacturing practices: supplementary guidelines for the manufacture of herbal medicinal products may be consulted when the GMP for an individual country is prepared.
A phased approach to the implementation of GMP may be required.
7.3 Training of regulatory staff
The agency administering the regulatory system should develop appropriately qualified staff resources, capable of making informed decisions in the area of herbal medicines. This may involve the provision of specific training programmes.
7.4 WHO certification scheme on the quality of pharmaceutical products moving in international commerce
Countries that do not have professional staff or laboratories to evaluate and handle extensive documentation for registration, may wish to take into account regulatory decisions made in other countries. The WHO certification scheme on the quality of pharmaceutical products moving in international commerce could be applied.
The aim of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce is to assure the quality of imported drugs, especially in small countries that have no drug registration system or no facilities for the systematic evaluation of the quality, efficacy and safety of pharmaceutical products.
A certificate is issued by drug regulatory authorities in exporting countries on request from drug regulatory authorities in importing countries. The certificate issued under the scheme confirms that:
(1) the pharmaceutical product mentioned in the certificate has been: evaluated for quality, safety and efficacy; registered in the country of origin; and approved for sale in that country. An explanation is required if any of these three criteria are not met;
(2) the pharmaceutical product has been manufactured according to Good Manufacturing Practices and that the manufacturing plant in the country of origin has been regularly inspected by the drug regulatory authorities to confirm compliance with GMP;
(3) the labelling and any other written information accompanying the product has been approved by the drug regulatory authority in the country of origin.
A similar system could be used for herbal medicines available for the international market.
8.1 General considerations
8.1.1 Each country or area should adopt a regulatory system to manage the appropriate use of herbal medicines. Adopting a regulatory mechanism will help ensure that herbal medicines have acceptable quality, safety and efficacy. The WHO Guidelines for the assessment of herbal medicines should be consulted when assessment processes for herbal medicines are being prepared.
Legislation should act as clear guidelines to industry and in its formation should draw on the expertise of a wide range of stakeholders (industry, consumers, practitioners, etc).
Legislation on herbal medicines should also recognise specific issues such as traditional history of use and/or level of current (unregulated) usage in the community. As a general principle, the history of use of a substance should in most cases be adequate evidence of its basic safety, provided its proposed application appropriately reflects its historical use.
8.1.2 Characteristics of herbal medicines
Herbal medicines have several attributes which differ from chemical synthetic drugs.
Herbal medicines are major remedies used by traditional systems of medicine which were developed based on different concepts from those of modern medicine.
Herbal medicines, as defined above, are usually mixed chemical compounds. Often not all active components of herbal medicines have been isolated, characterized or quantified. Efficacy is a result of the summation of pharmacological activity of an undefined blend of active components from one or more species of herb. Even a single plant material is not a purified single chemical compound. Standard techniques for the control of individual purified components may not be applicable for evaluating the quality of herbal medicines. In most cases it may not be appropriate to transfer the existing controls on chemical drugs to herbal medicines.
Where herbal medicines are not prepared by traditional methods it would need to be established that the processes have not changed the safety and therapeutic activity of the herbal medicines.
8.1.3 The regulatory process is a mechanism for evaluating the safety, efficacy and quality of medicinal products. The levels of evaluation may vary depending on the product. A comprehensive regulatory system for pharmaceutical products would require adequate data on pharmaceutical chemistry, pharmacological and toxicological studies, clinical investigations and therapeutic applications. However, for herbal medicines some modifications to the regulatory system are necessary. The registration requirement for herbal medicines would most likely be different from that for purified chemical drugs.
8.1.4 Various assessment procedures can be established with consideration of the categories of herbal medicine and different country situations.
(a) Notification procedure (listing): This involves obtaining information on herbal medicines which are being sold in a certain country. The amount of information requested in a notification may vary. It may initially be restricted to the names of herbal medicines and of manufacturers or importers if the medicine is imported from other countries. It may then be expanded to require notification of the composition, the pharmacological action, and the therapeutic classification. The assessment of listed herbal medicines may focus solely on the safety and quality for each intended use.
The listed herbal medicines may include those used traditionally, which are well-established, and those only used for simple, self-limiting conditions, without therapeutic claims having been assessed.
(b) Registration procedure (licensing): This comprises detailed evaluation of data submitted in support of the safety, efficacy, and quality of pharmaceutical products. It also determines the indications for its use. The procedure includes an assessment of both the herbal medicinal product, manufacturing procedures and facilities.
8.1.5 All manufacturing procedures should be in accordance with Good Manufacturing Practices (GMP). However, for many developing countries, medicinal herbal products are manufactured by factories, small workshops or traditional medical practitioners which may not meet GMP requirements. Countries should establish a process for manufacturers to acquire GMP status within an established timeframe.
8.1.6 Different regulatory procedures may be applied to raw plant materials, processed plant materials and medicinal herbal products. In some countries, raw plant materials may not be required to be regulated.
8.1.7 For toxic plant materials, the regulatory authority may issue a list of controlled toxic plant materials to guide manufacturers, wholesalers or importers and the public. The use of listed toxic medicinal substances may need special regulations.
8.1.8 For countries where a mechanism for the regulation of herbal medicines has not yet been established, the regulation procedure could be initiated step by step. A first stage notification (listing) procedure will provide useful data on medicinal herbal products available on the market. Depending on human resource and laboratory facilities, more comprehensive regulatory procedures could be implemented in order to achieve an acceptable level of safety, quality and efficacy.
8.2 Requirements for raw plant materials
While a regulatory system for raw plant materials used in individual dispensing would be difficult and impractical to implement, plant materials identified as toxic should be subjected to specific regulatory procedures. Plant materials classified as toxic should be dispensed only by appropriately qualified practitioners.
At all levels of handling of raw plant materials, clear and accurate identification and labelling is paramount. Countries should also give consideration to mechanisms for controlling contamination of raw plant materials with pests, microorganisms, aflatoxins and other mycotoxins, pesticides, heavy metals and other foreign matters.
8.3 Requirements for processed plant materials
8.3.1 Processed plant materials may be supplied as ingredients to practitioners or as starting materials to product manufacturers. In these cases, the following information should be supplied:
(a) taxonomical classification of the plant including genus, species and family;
(b) common names;
(c) expected countries of origin;
(d) part of the plant used and its condition (such as fresh aerial part; dried root and rhizome, sliced or decorticated);
(e) year, season, preliminary preparation and drying and methods of collection, if necessary;
(f) the method of preparation, including details of new processing techniques; and
(g) the excipients used (where relevant) for commercial reasons.
8.3.2 Where, for commercial reasons, the supplier/manufacturer of processed medicinal materials does not wish to provide details of the extraction methodology or excipients used to the manufacturer or practitioner, a notification (listing) or registration procedure could be implemented. In this case, particularly if using new processing methods, in addition to the information required under 8.3.1, the following information, may also be required, if relevant:
(h) characterizing compounds of the processed medicinal material and the chromatogram of the characterizing compounds;
(i) data on long-term toxicity tests, if appropriate;
(j) data on mutagenicity tests;
(k) data on carcinogenicity tests, if appropriate;
(k) data on reproductive and developmental toxicity tests when necessary;
(l) stability tests;
(m) quality standard, including the assay or limit of toxic ingredients, microorganisms, mycotoxins, heavy metals and pesticide, insecticide and herbicide residues; and
(n) reports on clinical trials, when necessary.
8.4 Requirements for medicinal herbal products
For medicinal herbal products a notification (listing) or registration procedure should be used in most cases. The manufacturers, distributors or importers should provide information on items listed below in relation to the product. In general, the requirements for medicinal herbal products would be pertaining to the product, however, data on individual components may in some circumstances be required. Efforts should be made to achieve high standards of practice in this area wherever possible.
(1) For traditionally used medicinal herbal products the following are needed:
(a) name of the product;
(b) list of ingredient(s) (active and inactive) of the product with scientific name(s), part of the plant used, and quantity; and with reference to the source text for the prescription, if available;
(c) the list of plant ingredient(s) of the product with taxonomic classification, including species, genus, and family;
(d) methods and technology used in manufacture;
(e) physical and chemical identification tests;
(f) quality standards for the ingredients when necessary (which may include the limit of residue of heavy metals and pesticides, insecticide and herbicide);
(g) quality standards for the products;
(h) stability tests;
(i) therapeutic uses and dosage;
(j) evidence of traditional use or recent clinical experience with the product in the form proposed, to support the safety and efficacy of the product;
(k) package and packaging materials; and
(l) content on label or package insert.
For those traditionally used herbal medicines with new dosage forms or new administration routes, the following additional data may be needed:
(m) comparative data on bioavailability.
For special dosage forms, such as injections and nebulisers, additional data may be required.
For those traditionally used herbal medicines with new indications, the following data, additional to items (a) to (l) may be needed:
(n) reports on clinical trials.
(2) For new medicinal herbal products which contain herbs with no traditional history of use, the following data should be submitted, in addition to the data on items (a) to (l) listed above:
(a) data on pharmacodynamic, bioavailability tests, and general pharmacological studies;
(b) data on acute toxicity tests;
(c) data on long-term toxicity tests, if necessary;
(d) data on mutagenicity tests, if necessary;
(e) data on carcinogenicity tests, if necessary;
(f) data on reproductive and developmental toxicity tests, if necessary; and
(g) reports on clinical trials.
(3) For importing countries, confirmation of the regulatory status in the country of origin should be required. Countries should consider extending the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce to cover medicinal herbal products. Where countries and areas have not yet adopted this scheme, the importers should submit a certificate of free sale and certificates of Good Manufacturing Practice (GMP) for the country of origin. Those certificates should be issued by the drug regulatory authority of the country of origin. After reviewing all the documents, a registration or notification (listing) may be given to medicinal herbal products imported by individual importers and the registration or listing number must appear on the labels of medicine.
8.5 Label requirements
It is recommended that the following is printed on the product label in the official language(s) used by the countries or areas:
(a) name of product;
(b) name and quantity (in dry weight when relevant) of active ingredient(s);
(c) dosage form;
(d) directions for use including indications, dosage, mode of administration, duration of use, age group limitations, and use during pregnancy and lactation;
(e) warning statements and relevant contraindications, adverse effects, if any, and overdose information when relevant;
(f) batch number;
(g) expiry date;
(h) storage conditions;
(i) name and address of manufacturers and/or importers; and
(j) registration or notification (listing) number.
The scientific name of active ingredient(s), in addition to the common name in the language of preference of the national regulatory authority, should be used.
The label and package insert should be “user-friendly”. Easy and understandable information should be provided.
The drug regulatory authority may provide to industry directions on labelling and on allowable indications and claims.
8.6 Responsible government agency for regulation
The responsible government agency could be the Drug Regulatory Authority or other government agencies with similar responsibilities. It is recommended that a special unit for herbal medicines should be created under the responsible agency for the regulation of medicines.
The responsible agency should review and evaluate all the data received from manufacturers or wholesalers. The applicants should be informed on time whether or not their products have been accepted for notification (listing) or registration.
The responsible agency should keep all the records for registration or notification of herbal medicines.
A registration or notification number should be given when an herbal medicine has been accepted with the drug regulatory authority. A certificate of registration or notification will be issued to each herbal medicine accepted by the relevant authority.
The regulatory authority should provide information to medical practitioners, pharmacists, owners of herbal drug stores and the public on the regulatory process and should have available a list of accepted medicinal herbal products.
8.7 Promotion and advertisement of herbal medicines
Advertisements and other promotional activities aimed at health personnel and the public should be fully consistent with the accepted product information. Restrictions may be placed on some advertising claims consistent with public health and safety.
8.8 Monitoring of adverse reactions to herbal medicines
The regulatory authority should establish a system for monitoring or surveillance of adverse reactions to herbal medicine. In the first instance, manufacturers should be encouraged to submit reports of adverse reactions. Ultimately, post-marketing surveillance should be required for medicinal herbal products which contain either toxic ingredients or present with new indications, new processing methods or routes of administration. Practitioners and consumers should be encouraged to report any adverse effects related to the use of medicinal herbal products. The regulatory authorities should investigate reported cases of adverse effects and, if necessary, issue relevant warnings or impose further restrictions oh the use of the medicinal herbal product. Regulatory authorities are encouraged to maintain accurate records of reported adverse reactions to herbal medicines and to make available that information to other Member States on request.
9. Use of the guidelines
These guidelines for the appropriate use of herbal medicines are intended to facilitate the work of national health authorities. It is hoped that they can cover a wide range of issues and meet the different situations of countries and areas in the Region. These guidelines can be modified by each Member State to suit their own specific needs. It is hoped that each interested country will eventually develop its own management and regulatory system for herbal medicine which will best suit its own situation. A phased approach to the adoption of the guidelines should be considered by Member States.
These guidelines also provide reference points for researchers, manufacturers and traders.