Advancing the Regulation of Traditional and Complementary Medicine Products: A Comparison of Five Regulatory Systems on Traditional Medicines with a Long History of Use

Table 4

Comparison of the registration dossier requirements.

	The item of major registration documents	Classic Chinese medicine formulation (China)	Standard formulation of Chinese medicine (Taiwan)	Established medicine (Hong Kong)	Kampo medicine (Japan)	Herbal drug (Korea)
(1) General documents	(1.1) Origin or background of discovery, conditions of use in foreign countries	×	×	×	×	⃝
	(1.2) The therapeutic group, comparisons with other drugs, and related information	×	×	×	⃝	⃝
(2) Product quality documents	(2.1) Quality data on crude drugs
	(2.1.1) The production information of crude drugs	⃝	×	×	×	×
	(2.1.2) The resource evaluation of crude drugs	⃝	×	×	×	×
	(2.1.3) Quality standards study data of crude drugs	⃝	×	×	×	⃝
	(2.1.4) Quality standards	⃝	×	⃝	×	⃝
	(2.1.5) Test report	⃝	×	⃝	×	⃝
	(2.2) Quality data on prepared slices of crude drug
	(2.2.1) Processing information	⃝	×	×	×	×
	(2.2.2) Quality standards study data of crude drugs	⃝	×	×	×	×
	(2.2.3) Quality standards	⃝	×	×	×	×
	(2.2.4) Test report	⃝	×	×	×	×
	(2.3) Quality data on corresponding objects of substance benchmark	⃝	×	×	×	×
	(2.4) Manufacturing method data of the product
	(2.4.1) Study data on manufacturing method in each step	⃝	×	×	×	⃝
	(2.4.2) Manufacturing verification or recorded data	⃝	⃝	×	×	×
	(2.4.3) Description of manufacturing method	⃝	⃝	⃝	×	⃝
	(2.5) Quality data on product
	(2.5.1) Quality standards study data	⃝	△	×	⃝	⃝
	(2.5.2) Quality standards	⃝	⃝	⃝	⃝	⃝
	(2.5.3) Test report	⃝	⃝	⃝	⃝	⃝
	(2.6) Stability test report	⃝	⃝	⃝	△	⃝
	(2.7) Data for container and packaging material	⃝	×	×	×	⃝
(3) Product safety documents	(3.1) Acute, subacute, and chronic toxicity, teratogenicity, and another type of toxicity
	(3.1.1) Single-dose toxicity test report	⃝	×	⃝	×	⃝
	(3.1.2) Repeated-dose toxicity test report	⃝	×	⃝	×	△
	(3.1.3) Genotoxicity test report	×	×	×	×	×
	(3.1.4) Local irritation test report	×	×	⃝	×	△
	(3.1.5) Carcinogenicity test report	△	×	×	×	×
	(3.1.6) Reproductive toxicity test report	△	×	×	×	×
	(3.1.7) Other toxicity tests	×	×	×	×	×
(4) Product efficacy documents	(4.1) Reference materials on product efficacy	⃝	×	⃝	×	×
	(4.2) Absorption, distribution, metabolism, and excretion study	×	×	×	×	×
	(4.3) Pharmacodynamic study (primary and secondary)	×	×	×	×	×
	(4.4) Pharmacological study	×	×	×	×	×
	(4.5) Clinical trial report	×	×	×	×	×

○: data submission is required; △: data submission to be required is case-based; ×: data submission is exempted.