Traditional Medicines and OTC Products
A legal intro to traditional medicines and OTC products in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Traditional Chinese Medicine (TCM) is a system for diagnosis, prevention and treatment that has existed for thousands of years and is regulated by the Regulations on Protection of Varieties of TCM and other relevant regulations. The regulatory requirements for such medicines are as follows:
- Entry of foreign investment: foreign investors are prohibited to invest in the application of steaming, frying, simmering and calcining and other processing techniques for Chinese herbal medicines and the production of confidential prescription products of proprietary Chinese medicine.
- Classification: the protected varieties of TCM shall be classified into first class and second class. The varieties of Chinese medicine that meet one of the following conditions shall be eligible for an application for the first-class protection: (1) with curative effect on a particular disease; (2) artificial product from varieties of wild Chinese medicinal materials under the national first class protection; or (3) applicable to the prevention of and treatment for a peculiar disease. The varieties of Chinese medicine that meet one of the following conditions shall be eligible for an application for the second-class protection: (1) the varieties that satisfy the provisions of first-class protection or the varieties with the first-class protection being lifted; (2) with remarkable curative effect on a particular disease; or (3) efficacious substances or special preparation extracted from natural pharmaceutical materials.
- Time limit of protection for varieties of TCM: for a variety of TCM under the first-class protection: 30 years, 20 years or 10 years; for a variety of TCM under the second-class protection: 7 years.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Only those traditional, herbal, complementary, or alternative products that can be sold without the prescription may be advertised directly to the public.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
Advertising of TCMs that do not need prescription follows the same rules as advertising of OTC medicines.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
OTC drugs in China refer to the drugs which can be purchased or used by consumers without prescriptions from licensed doctors. The categorization of OTC drugs is subject to the approval of the NMPA.
OTC drugs are divided into Class A and Class B drugs. Drugstores can sell both classes directly to consumers, but general commercial stores such as supermarkets and convenience stores can only sell Class B OTC drugs. Class A OTC drugs must be sold by the pharmaceutical retail enterprise with practicing apothecaries or other pharmaceutical technical personnel whose qualifications have been certified according to applicable laws. Where there is no drug retail enterprise at town or country fairs in remote areas with poor communications, the local drug retail enterprise may, after obtaining approval from the local drug regulatory institution of the county (municipality) and being registered with the administrative department for industry and commerce, set up stores at the fairs to sell OTC drugs within the approved scope for drug distribution.
5. Are there any limitations on locations or channels through which OTC products may be sold?
Please refer to Question 4 above.
6. What health, advertising, and marketing claims may be made for OTC products?
The medical advertisements must contain the generic name, a statement of advice “Please purchase and use in accordance with the drug instructions or under the guidance of pharmacist”, its medical advertisement permission number and its approval number for production. Meanwhile, an addition of the special label (OTC) for OTC drugs should be indicated in the advertisements for such nonprescription drugs.
7. Can OTC products be marketed or advertised directly to the public?
OTC products may be marketed or advertised to the general public directly upon the approval of NMPA. Please refer to Questions 17 & 20 of the Marketing, Manufacturing, Packaging & Labeling, Advertising article.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
The NMPA has the authority to revise and publish the list of OTC drugs. Alternatively, the marketing authorization holders can apply to the NMPA for the conversion between prescription drugs and OTC drugs.
9. What are the requirements for the importation of either traditional medicines or OTC products?
The requirements for the importation of either traditional medicines or OTC products are generally the same as that for chemical drugs or prescription drugs. All drugs imported into China should obtain the Imported Drug License from the NMPA.