Regulatory Situation of Herbal Medicines A worldwide Review

WHO/TRM/98.1page 35In New Zealand, herbal medicines are dealt with in two ways according to the Medicines Act of 1981. On theone hand, any herbal remedy may be manufactured and sold if requested for the expressed purpose oftreating a particular person. This remedy must not contain a scheduled medicine and must be supplied undera designation that specifies the plant and the process of manufacture of the remedy, without any other nameand without any written recommendation as to the use of the remedy. In these cases, no licensing and noassessment is required.On the other hand, for any herbal medicine not covered by the above-mentioned conditions, marketingapproval is required. The assessment of herbal medicines is carried out in the same way as for proprietarymedicines by the Therapeutics Assessment and Utilization Section of the Department of Health. Theapplication includes control of active ingredients and excipients, method of manufacture, control tests of thefinished product, labelling, stability etc.The efficacy of herbal medicines is not evaluated critically. Often there are hardly any clinical data for efficacy,since most of these remedies are prescribed on a patient basis. Supporting evidence for efficacy may includereferences in standard books, unless this information has been superseded by more recent research data.Indication claims are restricted to self-limiting conditions. In some cases, where there is concern about safety,toxicity data have to be provided; if not, a withdrawal from the market may be the consequence [139].PhilippinesCultivation and use of medicinal plants in the Philippines date back to the pre-Spanish times, and studiesbegan in the 16th century, mostly written by Spanish missionaries. Complete and very useful information onthe treatment of diseases is provided by the book of Dr Pardo de Tavera "Plantas Medicinales de Filipinas"published 1892. The first official mandate in recent years that recognized the usefulness of medicinal plantshas been the Letter of Instruction issued by the Department of Education in 1973 encouraging public schoolsto include medicinal plants in health education.In history, traditional healers (herbolarios) were the first who recommended the use of plant preparations.Now, especially in rural areas where the use of plants for common ailments has never been abandoned,these experiences of community-based health programmes have been very encouraging. It has been shownin several studies that people living in rural areas tend to use more traditional herbal medicines than Westerndrugs compared to people living in urban areas [140].Legal StatusThe regulation and control of herbal products, whether food or medicines, are under the authority of the Bureauof Food and Drugs (BFAD) of the Department of Health. Two administrative orders, issued in 1982 and 1984,require that all traditional drugs both local and imported comply with registration and quality controlrequirements. An official list of traditional products had to be established according to these orders. Among thequality control requirements are tests for the presence of synthetic drugs (especially analgesics, anabolics,corticosteroids, hormones), heavy metals, alcohol content and impurities. Tests for galenical forms arerequired as well as microbial tests and stability data.A monitoring system for import and export of medicinal plant products does not exist. Imported products maybe sold in Chinese drug stores. Small community manufacturing of medicinal plants in tea bags, capsules orsyrups has proliferated, but no regulation or control has been implemented. It is regarded as very importantthat the traditional medical system remains distinct from Western medicine, but might complement it.Therefore, the use of safe and effective herbal medicines should be effectively promoted but without falsehopes and expectations [140].In 1987, the National Drug Policy was adopted, emphasizing quality assurance and rational use of drugs.Since then, 10 policies have been adopted of which one dealt with research on traditional healing methodsand promotion of the use of medicinal plants [140].In October 1995, the Department of Health's (DOH) Circular 168-A was signed by the Secretary of Health. Thiscircular lists herbal medicinal plants which are being studied, utilized and promoted by the DOH to serve assafe and effective alternative medicines in the health care delivery system. The list includes 10 scientificallyvalidated medicinal plants and 70 plants which are presently undergoing further studies by governmentresearchers [127].Republic of Korea