IARC MONOGRAPHS ON THE EVALUATION OF CARCINOGENIC ...

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of adverse reactions to OTC drugs. The third system is Adverse Reaction Reporting from
Manufacturers. These cases are reported to the MHW by the responsible company, with
information arising from medical conferences and from journals.
3.3.8 Korea (Republic of)
The Pharmaceutical Act of 1993 explicitly allowed pharmacists to prescribe and
dispense herbal drugs (Cho, 2000).
3.3.9 China
IARC MONOGRAPHS VOLUME 82
Many herbal medicines have been used for hundreds of years and it is assumed in
many cases that they must work. For example, about 7000 species of plants are used in
China as herbal medicines, but only 230 of the most commonly used ones have been
subject to in-depth pharmacological, analytical and clinical studies.
The 2000 edition of the Chinese pharmacopoeia included 784 items on traditional
Chinese medicines and 509 on Chinese patent medicines. Herbal medicines in China are
normally considered as medicinal products with special requirements for marketing.
New drugs have to be investigated and approved according to the Drug Administration
Law. New traditional Chinese medicines are classified under five categories based on the
Amendment and Supplement Regulation of Approval of new traditional medicines:
Class 1
(1) Artificial alternatives of Chinese crude drugs.
(2) Newly discovered Chinese crude drugs and their preparations.
(3) Active constituents extracted from Chinese crude drugs and their preparations.
(4) Active constituents extracted from a composite formulation of traditional
Chinese medicines.
Class 2
(1) Injection of traditional Chinese medicines
(2) Use of new medicinal parts of Chinese crude drugs and their preparations.
(3) Effective fractions extracted from Chinese crude drugs or natural drugs and
their preparations.
(4) Chinese crude drugs artificially developed in an animal body and their
preparations.
(5) Effective fractions extracted from a composite formulation.
Class 3
(1) New composite formulations of traditional Chinese medicines.
(2) Composite preparations of traditional Chinese medicines and chemical drugs
with the main efficacy due to the traditional Chinese medicine.
(3) Domestically cultivated or bred crude drugs originally imported and commonly
used in China, and their preparations.