Chinese Traditional Medicine Regulation

Traditional Chinese Medicine Law (2017)

The Traditional Chinese Medicine Law of the People’s Republic of China (Zhongyiyao Fa, 中医药法), effective 1 July 2017, is the foundational legal instrument for the regulation of traditional Chinese medicine (TCM). The Law defines TCM as the collective term for the medical sciences of the Han and minority ethnic groups in China, reflecting the historical and cultural traditions of the Chinese people and containing unique theories and technical methods for disease prevention and treatment.

The Law was adopted after 33 years of legislative deliberation. It established TCM as equal in legal status to Western medicine (xiyi) and required the state to support the development of both systems. The Law addresses TCM classification, hospital regulation, practitioner licensing, patent medicine regulation, education, and international cooperation.

TCM Classification

The 2017 Law classifies TCM into three categories: pure TCM (chun zhongyi) — diagnosis and treatment using only TCM methods (herbal medicine, acupuncture, moxibustion, massage, cupping); integrated TCM-Western medicine (zhongxiyi jiehe) — combining TCM and Western medical approaches with the practitioner qualified in both; and national minority medicine (minzu yi) — the traditional medical systems of China’s minority nationalities, including Tibetan medicine (zang yi), Mongolian medicine (meng yi), Uyghur medicine (wei yi), and Dai medicine (dai yi).

The Law requires the state to protect, develop, and study national minority medicine. Minority medicine institutions receive government funding and are regulated under the TCM Law with modifications to account for differences in diagnostic and therapeutic methods.

TCM Hospital Regulation

TCM hospitals are regulated under the Law’s provisions on TCM medical institutions. The Law requires that TCM hospitals incorporate TCM diagnostic and therapeutic methods as their primary service model. A TCM hospital must have at least two-thirds of its medical staff practising TCM and must use TCM methods for at least 60% of its patient consultations.

The regulatory framework distinguishes between public TCM hospitals — which are established by the government and receive public funding — and private TCM clinics (zhongyiyao zhensuo), which are established by TCM practitioners. Private TCM clinics are permitted to operate without a registered TCM physician on staff where the clinic owner holds a TCM qualification and the clinic uses only TCM methods.

Patent Medicine

TCM patent medicines (zhongchengyao) — ready-made TCM preparations in pill, capsule, or liquid form — are regulated under the Drug Administration Law (修订后的药品管理法, 2019 revision) and the TCM Law. Patent medicines must be approved by the National Medical Products Administration (NMPA, formerly the China Food and Drug Administration) before they may be marketed.

The approval process for TCM patent medicines differs from the process for Western pharmaceuticals. The NMPA evaluates TCM patent medicines based on: (1) the rationale of the component herbal ingredients based on TCM theory; (2) the safety data from clinical trials (or from documented historical use); (3) the quality consistency of the preparation; and (4) the demonstrated efficacy in TCM-specific clinical trials. The Law permits the approval of TCM patent medicines based on “evidence of clinical application experience” where the preparation has a documented history of safe use.

The 2020 Measures for the Registration of TCM Patent Medicines (2020) introduced a special registration pathway for TCM preparations whose ingredients and preparation methods are consistent with TCM classical prescriptions (jingdian mingfang). The classical prescription pathway requires less extensive clinical trial data and is intended to accelerate the approval of preparations with documented historical efficacy.

TCM Practitioner Licensing

TCM practitioner licensing is governed by the Regulations on the Administration of TCM Practitioners and the Provisions on the Examination and Registration of TCM Practitioners.

The Law establishes two pathways to TCM practitioner qualification. The standard pathway: a TCM practitioner must graduate from a recognised TCM university programme (typically 5 years for a bachelor’s degree), pass the National TCM Practitioner Qualification Examination, and complete a one-year clinical internship. The mentorship pathway (shicheng): a person who has studied TCM under a qualified master TCM practitioner for at least three years, or who has acquired TCM knowledge through more than five years of clinical practice, may apply for the TCM practitioner examination without a formal university degree. The mentorship pathway was introduced by the 2017 Law to preserve TCM knowledge transmission outside the formal education system.

The TCM practitioner examination covers TCM theory, diagnosis, herbal medicine, acupuncture, and integrative medicine (including basic Western medical knowledge). Successful examinees are issued a TCM Practitioner Certificate and must register with the local health bureau before practising.

The Law also provides for the licensing of TCM massage practitioners and TCM rehabilitation therapists, whose scope of practice is limited to specific TCM techniques and does not include herbal prescribing or acupuncture.

Integrative Medicine

Integrative medicine (zhongxiyi jiehe) is formally recognised as a medical specialisation. Integrative medicine practitioners must hold qualifications in both TCM and Western medicine. The education pathway includes an integrative medicine university programme (typically 6 years) that covers both TCM and Western medical curricula, and a postgraduate clinical training programme.

Integrative medicine hospitals and departments exist within the public hospital system. The 2017 Law requires general public hospitals to establish TCM departments or to offer integrated TCM-Western medicine services. The integration policy aims to combine TCM’s holistic diagnostic approach with Western medicine’s diagnostic technology and acute care capability.

International Recognition

The international recognition of TCM is a policy priority. The TCM Law (Articles 43-45) requires the State Administration of TCM to: promote TCM international standards through the International Organization for Standardization (ISO); support the establishment of TCM clinics and TCM educational programmes abroad; and negotiate mutual recognition agreements for TCM qualifications with other countries.

TCM has been increasingly recognised internationally. Acupuncture is regulated as a medical profession in over 50 countries. TCM herbal medicine is registered as traditional medicine or food supplement in the EU, Australia, and Canada. The WHO International Classification of Diseases (ICD-11), effective 2022, includes a chapter on traditional medicine conditions, providing a standardised diagnostic framework for TCM.

China has also used TCM recognition as a component of its Belt and Road Initiative. The Belt and Road TCM Development Plan (2017) committed China to establishing TCM centres in 30 countries along the Belt and Road corridors, with Chinese government support for TCM regulation, education, and clinical services.

Conclusion

The 2017 TCM Law provided comprehensive legal recognition and regulation of traditional Chinese medicine, establishing its equal status with Western medicine, regulating hospital and practitioner licensing, creating the classical prescription pathway for patent medicine approval, and promoting international recognition. The Law’s accommodation of the mentorship pathway preserves traditional knowledge transmission. The integration of TCM with Western medicine within the public hospital system has created a dual medical system unique to China, raising questions about the quality of evidence for TCM efficacy, the potential for adverse interactions between TCM and Western pharmaceuticals, and the allocation of public health resources.