Regulatory Situation of Herbal Medicines - A Worldwide Review
(1998; 49 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentACKNOWLEDGEMENTS
View the documentFOREWORD
Open this folder and view contentsI. INTRODUCTION
Close this folderII. REGULATORY SITUATION
Open this folder and view contentsAfrica
Open this folder and view contentsThe Americas
Open this folder and view contentsEastern Mediterranean
Open this folder and view contentsEurope
Open this folder and view contentsSouth East Asia
Close this folderWestern Pacific
View the documentAustralia
View the documentChina
View the documentHong Kong
View the documentMacao
View the documentFiji
View the documentJapan
View the documentMalaysia
View the documentMongolia
View the documentNew Zealand
View the documentPhilippines
View the documentRepublic of Korea
View the documentSingapore
View the documentViet Nam
View the documentIII. CONCLUSION
View the documentIV. REFERENCES
 

Republic of Korea

The 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. The empirical folk medicine has passed on from generation to generation and is not prescribed by Korean oriental physicians.

Legal Status

The Composite Pharmacy Law governs all activities concerning pharmacies, pharmaceutical industries, and suppliers of medicines including herbal raw materials. The two official drug compendia are the fifth edition of the 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 a herbal preparation could be prepared by a pharmaceutical company without submitting any clinical or toxicological data, provided that the formula is described in the eleven classic books on traditional Korean and Chinese medicines [141].

Since 1983, the government has been working on standardization of 530 medicinal plants, including 145 which were already listed in the Korean Pharmacopoeia. Since 1993, only standardized medicinal plants can legally be distributed. For herbal medicines produced by domestic pharmaceutical companies, the government imposes strict regulations on these companies, so that they follow the GMP standard in manufacturing herbal medicines.

For the production of well controlled herbal raw materials, the Ministry of Public Health and Social Affairs has published 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 requirements of the Korean Pharmacopoeia, the National Institute of Health and the Ministry of Public Health and Social Affairs. 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 combination of several herbs, hundreds of natural constituents would have to be assayed in quality control. For this reason the National Institute of Health employs approximate assay methods within which an active natural product or an indicative substance may be analyzed in quality control [141].

The Medical Act and the Drug Administrative Act stipulate that only certified oriental medical doctors or pharmacies with oriental medical doctors' prescriptions can provide patients with any of the herbal medicines listed in the Korean Pharmacopoeia [142].

Market Importance of Oriental Medicine

About 500 doctors a year from 11 schools become oriental medical doctors. At present, registered oriental medical doctors number 5 792, accounting for 12% of all doctors. Among them, 4 208 work in urban areas and 399 in rural areas, with 324 working for general hospitals or oriental medical hospitals, and 4 283 running private clinics. The number of beds in oriental medical facilities is 1 276 or 1.05% of the total number of beds nationwide [141].

Oriental Health Insurance

July 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 might because of limited insurance coverage. For example, insurance benefits for these medicines are granted for only 68 single formula extracts out of a total of 530, and for only 56 compound formula medicines out of 250. In 1990, oriental health insurance covered only 1.1% of total treatment cases, and accounted for 0.6% of the total account 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].

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