Based on the amendment and Supplemental Regulation of Approval of New TCM Drugs implemented in 1992 [The approval of new pharmaceuticals (concerning the revision and the additional regulations on the sections on Chinese Traditional Medicine) implemented on 1 September 1992. Ministry of Health of the People’s Republic of China], new TCM drugs are classified under five categories:

Category 1

1. Artificial imitations of TCM herbs
2. Newly discovered medicinal plants and their preparations
3. Single active principal extracted from TCM plant materials and their preparations

Category 2

1. Chinese medicinal herbal injections
2. Parts of TCM medicinal plants newly employed as a remedy and their preparations
3. Non-single components extracted from TCM and natural plants and their preparations
4. TCM materials obtained by artificial techniques in vivo and their preparations

Category 3

1. New TCM preparations
2. Combined preparations of TCM and modern medicine in which TCM medicine is the main component
3. Cultivated material which traditionally is imported

Category 4

1. New dosage forms or new routes of administration of TCM drug
2. Materials introduced from other parts of the country and those for cultivation instead of harvesting in the wild

Category 5

1. TCM products with new and additional indications.

For these categories, different requirements have to be fulfilled for medicinal materials and the pharmaceutical form. All research on new medicines should provide data on toxicity, pharmacological properties and clinical research, as well as detailed documentation on the quality of the medicinal material and the pharmaceutical preparation. Proprietary medicines included in the national pharmacopoeia and new medicines approved by the Ministry of Public Health are exempted from clinical testing when only the dosage form is changed, such as from powder to capsules, or from tablets to granular form infused with boiling water, without changes in the indications for cardinal symptoms or dosage. As per the technical requirements for pharmacological studies, tests on major drug effects are to be designed in such a way that the special characteristics of TCM are taken into consideration. Two or more methods shall be selected for research on the major drug actions, based on the effects of the new medicines on the complex of symptoms or the illness. For new medicines in categories 1, 2 and 3 this research shall be sufficient to verify the major therapeutic functions and effects. For new medicines in category 4, two tests on the major effects are required or well-documented material has to be submitted. For new medicines in category 5, only tests on the major effects of the medicine on ‘new’ cardinal symptoms are required. Research on general pharmacology shall be performed on the nervous system, on the cardiovascular system and on the respiratory system. Technical requirements for studies on toxicity are as required by the document. While clinical trials are divided into three phases, clinical verifications do not have phases. Clinical trials shall be conducted for new medicines of categories 1, 2 and 3 and clinical verifications are required for new medicines of categories 4 and 5.

Medicines in categories 1 and 2 which have either toxic or incompatible compounds need to go through Phase 1 clinical trial to study the reaction and tolerance of the human body to the new medicine and to assess the safe dosage.

Phase 2 clinical trials are undertaken to obtain an accurate evaluation of the curative effects of the new medicine and its safety and consists of two stages. While the first applies when treatment is performed, the second is applicable when it is to be expanded. Selection of cases, methods used are all as per standard norms and when curative effects are determined, four ratings are applicable, namely – clinical recovery, significantly effective, effective and non-effective. The evaluation of the curative effects shall be based on the clinical symptoms, objective standards for curative effects and the ultimate results on the patient. The objective of the Phase 3 clinical trial is the further investigation of the safe use or effectiveness of the new medicine on the basis of the findings of Phase 2.

Clinical verification applicable to new medicines of categories 4 and 5 is to observe their curative effects, contraindications and precautions.

Summary of the clinical trial shall be objective and comprehensive and shall be an accurate reflection of the whole process. The discussion in the final report shall include the conclusion which is based on the outcome of the tests, the functions and effects on cardinal symptoms, the scope of application of the new medicine, its administration, the course of treatment, curative effects, safety, adverse reactions, contraindications and precautions.

The Amendment and Supplemental Regulation of Approval of new TCM drugs has a special chapter on the technical requirements for studies on quality standards for Chinese medicinal material and medicines. These include the prescription, the way of processing, the properties, the identification, the examination and the assay in accordance with the general guidelines laid down in the pharmacopoeia. It also describes the requirements for studies on stability.