Regulatory Situation of Herbal Medicines A worldwide Review

WHO/TRM/98.1page 36The Republic of Korea has legally adopted two medicare systems, Western medicine and oriental medicine.Traditional medicine in Korea is based on both traditional Chinese medicine and Korean folk medicine. Theempirical folk medicine has passed on from generation to generation and is not prescribed by Korean orientalphysicians.Legal StatusThe Composite Pharmacy Law governs all activities concerning pharmacies, pharmaceutical industries, andsuppliers of medicines including herbal raw materials. The two official drug compendia are the fifth edition ofthe Korean Pharmacopoeia and the Korean Natural Drug Standards [141].In 1969, the Ministry of Public Health and Social Affairs published a notification which acknowledged that aherbal preparation could be prepared by a pharmaceutical company without submitting any clinical ortoxicological data, provided that the formula is described in the eleven classic books on traditional Korean andChinese medicines [141].Since 1983, the government has been working on standardization of 530 medicinal plants, including 145which were already listed in the Korean Pharmacopoeia. Since 1993, only standardized medicinal plants canlegally be distributed. For herbal medicines produced by domestic pharmaceutical companies, thegovernment imposes strict regulations on these companies, so that they follow the GMP standard inmanufacturing herbal medicines.For the production of well controlled herbal raw materials, the Ministry of Public Health and Social Affairs haspublished a notification under which a new licence will be issued to the manufacturer of standardized herbs.Herbal drugs and preparations thereof have to be standardized and controlled according to the requirementsof the Korean Pharmacopoeia, the National Institute of Health and the Ministry of Public Health and SocialAffairs. The information required for these products includes taxonomic status, parts of plants, morphology,qualitative examination, purity, content of essential oil or extract, and grade of quality.A single herb used in traditional medicine may contain hundreds of constituents. In the case of a combinationof several herbs, hundreds of natural constituents would have to be assayed in quality control. For this reasonthe National Institute of Health employs approximate assay methods within which an active natural product oran indicative substance may be analyzed in quality control [141].The Medical Act and the Drug Administrative Act stipulate that only certified oriental medical doctors orpharmacies with oriental medical doctors' prescriptions can provide patients with any of the herbal medicineslisted in the Korean Pharmacopoeia [142].Market Importance of Oriental MedicineAbout 500 doctors a year from 11 schools become oriental medical doctors. At present, registered orientalmedical doctors number 5 792, accounting for 12% of all doctors. Among them, 4 208 work in urban areas and399 in rural areas, with 324 working for general hospitals or oriental medical hospitals, and 4 283 runningprivate clinics. The number of beds in oriental medical facilities is 1 276 or 1.05% of the total number of bedsnationwide [141].Oriental Health InsuranceJuly 1989 witnessed the establishment of a national health insurance system in the Republic of Korea.Oriental health insurance which was introduced in February 1987, has failed to spread as much as it mightbecause of limited insurance coverage. For example, insurance benefits for these medicines are granted foronly 68 single formula extracts out of a total of 530, and for only 56 compound formula medicines out of 250. In1990, oriental health insurance covered only 1.1% of total treatment cases, and accounted for 0.6% of the totalaccount of benefits. The number of cases treated under oriental health insurance has increased 4.9 times,from 320 770 in 1987 to 1 558 906 in 1990 [141].SingaporeAlthough Western medicine is the main form of health care in Singapore, TCM continues to enjoy considerablepopularity, but its practice is confined to outpatient care. About 12% of daily outpatient attendance is estimated