Implementation Regulations of the Drug Administration Law of the People's Republic of China (Revised in 2026)
Implementation Regulations of the Drug Administration Law of the People's Republic of China (Revised in 2026)
Implementation Regulations of the Drug Administration Law of the People's Republic of China (Revised in 2026)
Order of the State Council of the People's Republic of China No. 828
January 16, 2026
The Implementation Regulations of the Drug Administration Law of the People's Republic of China, which were revised and adopted at the 76th Executive Meeting of the State Council on December 31, 2025, are hereby promulgated and shall come into force as of May 15, 2026.
Li Qiang, Premier
Implementation Regulations of the Drug Administration Law of the People's Republic of China (Revised in 2026)
(Promulgated by Order of the State Council of the People's Republic of China No. 360 on August 4, 2002; revised for the first time in accordance with the Decision of the State Council on Revising Certain Administrative Regulations on February 6, 2016; revised for the second time in accordance with the Decision of the State Council on Revising Certain Administrative Regulations on March 2, 2019; revised for the third time in accordance with the Decision of the State Council on Revising and Repealing Some Administrative Regulations on December 6, 2024; revised for the fourth time by Order of the State Council of the People's Republic of China No. 828 on January 16, 2026)
Chapter I General Provisions
Article 1 The Implementation Regulations of the Drug Administration Law of the People's Republic of China (Revised in 2026) (hereinafter referred to as the "Regulations") are formulated in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the "Drug Administration Law").
Article 2 In the development, manufacturing, distribution, use, supervision, and regulation of drugs, the relevant parties shall adhere to a people's health-centered approach, observe scientific laws and ethical principles, and comprehensively prevent and control risks.
Article 3 The State shall improve the drug innovation system, support clinical value-oriented drug development and innovation, encourage the research and creation of new drugs, and support the promotion and use of new drugs in clinical settings; promote the inheritance and innovation of traditional Chinese medicine (TCM), and fully leverage its role in prevention, medical treatment, and healthcare; promote the research and development of, and innovation in generic drugs, and improve their quality and efficacy.
Article 4 Departments in charge of drug supervision and regulation (hereinafter referred to as "medical products administrations") of people's governments at or above the county level shall be responsible for drug supervision and regulation. Other relevant departments of people's governments at or above the county level shall, within their respective duties, be responsible for supervision and regulation related to drugs.
Article 5 The competent authority of industry and information technology under the State Council, the competent authority of commerce under the State Council, and other relevant authorities shall, in accordance with the division of responsibilities and based on national economic and social development plans and the development of the drug industry, formulate the relevant national development plans and industrial policies for sectors such as drug manufacturing and circulation, promote structural adjustments and technological innovation in the drug industry, enhance the resilience and safety level of the industrial chain, and promote the high-quality development of the drug industry. The medical products administration under the State Council shall work in coordination with the competent authority of industry and information technology under the State Council, the competent authority of commerce under the State Council, and other relevant authorities to implement the relevant national development plans and industrial policies for the drug industry.
Chapter II Drug Development and Registration
Article 6 Entities that are engaged in drug development shall abide by the Good Laboratory Practice for Non-Clinical Laboratory Studies (GLP) and the Good Clinical Practice (GCP), ensuring that records and data are authentic, accurate, complete, and traceable.
Article 7 Non-clinical drug safety evaluation studies that are conducted for the purpose of applying for drug registration shall be carried out by accredited institutions that conduct non-clinical drug safety evaluation studies. An application for qualification accreditation as an institution that conducts non-clinical drug safety evaluation studies shall be submitted to the medical products administration under the State Council and shall be accompanied by supporting documentation that demonstrates its compliance with the GLP. The medical products administration under the State Council shall organize a review and make a decision within 20 working days of the date of acceptance of the application. Where the prescribed conditions are met, approval shall be granted and a qualification certificate shall be issued; in the case of non-compliance with the prescribed conditions, no approval shall be granted and reasons shall be given in writing.
The qualification certificate for institutions that conduct non-clinical drug safety evaluation studies shall be valid for five years. Upon expiration of the validity period, if continued conduct of non-clinical drug safety evaluation studies is required, an application for the reissuance of the qualification certificate shall be submitted.
Article 8 Sponsors of clinical drug trials shall select clinical drug trial institutions and investigators with the corresponding capabilities. They shall also fulfill responsibilities for subject protection, management of drugs for clinical trial use, clinical trial data management, and risk management.
The preparation of drugs for clinical trial use shall comply with the relevant requirements of the Good Manufacturing Practice for Pharmaceutical Products (GMP).
Sponsors of clinical drug trials and clinical drug trial institutions shall not charge subjects any fees related to the clinical trials.
Article 9 Where a change of the sponsor is proposed for a clinical drug trial that has been approved in accordance with Paragraph 1 of Article 19 of the Drug Administration Law, an application shall be submitted to the medical products administration under the State Council. The medical products administration under the State Council shall review the application and make a decision within 20 working days of the date of acceptance of the application.
Article 10 Drug development activities conducted outside the territory of China for the purpose of applying for drug registration shall comply with the relevant provisions of the Drug Administration Law, the Regulations, and other applicable laws, regulations, rules, standards, and norms; research data that are obtained outside the territory of China and meet the relevant requirements of the medical products administration under the State Council may be used for drug registration applications.
Article 11 The importation of comparator products or samples necessary for drug development or testing for registration purposes shall be subject to the approval of the medical products administration under the State Council; however, drugs for clinical trial use as specified in the clinical drug trial approval documents may be imported on the basis of such approval documents. The medical products administration under the State Council shall review the application and make a decision within 20 working days of the date of acceptance of the application.
Article 12 The development of chemical generic drugs shall be carried out in accordance with the technical requirements that are formulated by the medical products administration under the State Council, with comparator products scientifically selected for comparative studies; where reference listed drugs are designated by the medical products administration under the State Council, such reference listed drugs shall be selected as the comparator products for comparative studies.
Article 13 The development of TCM shall be guided by the TCM theory, and comprehensively evaluate the safety and efficacy of TCM based on the TCM theory, human experience in TCM use, and clinical trial data. The evaluation of the efficacy of TCM shall be consistent with its clinical positioning and reflect its characteristics.
Article 14 The development and manufacturing of TCM shall ensure the stability of the sources and quality of Chinese medicinal materials and the sustainable use of resources, and avoid adverse ecological and environmental impacts; where wild animals or plants are involved, the relevant provisions of the State shall be complied with.
Article 15 For drugs under application for registration, the medical products administration under the State Council shall carry out review and approval in accordance with Article 25 of the Drug Administration Law.
To support clinical value-oriented drug development and innovation, the medical products administration under the State Council may adopt a breakthrough therapy designation procedure, a conditional approval procedure, a priority review and approval procedure, a special approval procedure, and other measures for eligible drug registration applications to accelerate the marketing of drugs.
The medical products administration under the State Council shall establish and improve review and approval, inspection and testing, and standards management systems that accommodate the characteristics of TCM.
Article 16 When approving a drug, the medical products administration under the State Council shall review and approve its chemically active pharmaceutical ingredients concurrently; where the prescribed conditions are met, a drug registration certificate shall be issued for that drug, and an approval certificate for chemically active pharmaceutical ingredients shall be issued for the chemically active pharmaceutical ingredients. For chemically active pharmaceutical ingredients used in the manufacturing of generic drugs that have already been registered, an application for review and approval may also be submitted directly to the medical products administration under the State Council. Where the prescribed conditions are met, an approval certificate for chemically active pharmaceutical ingredients shall be issued. When reviewing and approving chemically active pharmaceutical ingredients, the medical products administration under the State Council shall concurrently approve the quality standards, manufacturing processes, and labels of such ingredients.
The transfer of a drug registration certificate or an approval certificate for chemically active pharmaceutical ingredients shall require an application to the medical products administration under the State Council. The medical products administration under the State Council shall review the application and make a decision within 20 working days of the date of acceptance of the application.
Article 17 The validity period of a drug registration certificate and an approval certificate for chemically active pharmaceutical ingredients shall be five years. Upon expiration of the validity period, where continued marketing is required, an application for re-registration shall be submitted.
A marketing authorization holder or a manufacturer of chemically active pharmaceutical ingredients shall apply for re-registration to the medical products administration of the local people's government at the provincial level; where a marketing authorization holder or a manufacturer of chemically active pharmaceutical ingredients is an overseas enterprise, it shall apply for re-registration to the medical products administration under the State Council.
Article 18 Where the circumstances for the registration of over-the-counter (OTC) drugs as specified by the medical products administration under the State Council are met, a drug registration applicant may directly submit an application for the registration of OTC drugs.
Where a marketing authorization holder of a registered prescription drug considers it suitable to be managed as an OTC drug, it may apply to the medical products administration under the State Council for its conversion to an OTC drug. Where a marketing authorization holder of a registered OTC drug, based on adverse reaction monitoring and post-marketing evaluation results, considers it unsuitable to be managed as an OTC drug, it shall apply to the medical products administration under the State Council for its conversion to a prescription drug. Where, after organizing an evaluation, the medical products administration under the State Council considers that the requirements are met, it shall decide to convert a prescription drug to an OTC drug or an OTC drug to a prescription drug, and issue a public announcement.
The medical products administration under the State Council may, based on the need to ensure public drug use safety and after organizing an evaluation, decide to convert an OTC drug to a prescription drug.
Article 19 The State shall promote the improvement in drug standards and continuously enhance the quality level of drugs.
The drug quality standards that are approved by the medical products administration under the State Council are drug registration standards. Drug registration standards shall comply with the general technical requirements of the Pharmacopoeia of the People's Republic of China and shall not be less strict than the corresponding national drug standards. A marketing authorization holder shall, in light of the formulation and revision of national drug standards, assess its drug registration standards, and where revision is necessary, revise them in a timely manner and submit a change application, or carry out filing and reporting in accordance with the provisions of the medical products administration under the State Council.
Article 20 In the development of drugs or in the application for drug registration, biological reference standards or chemical reference standards of national drugs shall be used.
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Order of the State Council of the People's Republic of China No. 828
January 16, 2026
The Implementation Regulations of the Drug Administration Law of the People's Republic of China, which were revised and adopted at the 76th Executive Meeting of the State Council on December 31, 2025, are hereby promulgated and shall come into force as of May 15, 2026.
Li Qiang, Premier
Implementation Regulations of the Drug Administration Law of the People's Republic of China (Revised in 2026)
(Promulgated by Order of the State Council of the People's Republic of China No. 360 on August 4, 2002; revised for the first time in accordance with the Decision of the State Council on Revising Certain Administrative Regulations on February 6, 2016; revised for the second time in accordance with the Decision of the State Council on Revising Certain Administrative Regulations on March 2, 2019; revised for the third time in accordance with the Decision of the State Council on Revising and Repealing Some Administrative Regulations on December 6, 2024; revised for the fourth time by Order of the State Council of the People's Republic of China No. 828 on January 16, 2026)
Chapter I General Provisions
Article 1 The Implementation Regulations of the Drug Administration Law of the People's Republic of China (Revised in 2026) (hereinafter referred to as the "Regulations") are formulated in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the "Drug Administration Law").
Article 2 In the development, manufacturing, distribution, use, supervision, and regulation of drugs, the relevant parties shall adhere to a people's health-centered approach, observe scientific laws and ethical principles, and comprehensively prevent and control risks.
Article 3 The State shall improve the drug innovation system, support clinical value-oriented drug development and innovation, encourage the research and creation of new drugs, and support the promotion and use of new drugs in clinical settings; promote the inheritance and innovation of traditional Chinese medicine (TCM), and fully leverage its role in prevention, medical treatment, and healthcare; promote the research and development of, and innovation in generic drugs, and improve their quality and efficacy.
Article 4 Departments in charge of drug supervision and regulation (hereinafter referred to as "medical products administrations") of people's governments at or above the county level shall be responsible for drug supervision and regulation. Other relevant departments of people's governments at or above the county level shall, within their respective duties, be responsible for supervision and regulation related to drugs.
Article 5 The competent authority of industry and information technology under the State Council, the competent authority of commerce under the State Council, and other relevant authorities shall, in accordance with the division of responsibilities and based on national economic and social development plans and the development of the drug industry, formulate the relevant national development plans and industrial policies for sectors such as drug manufacturing and circulation, promote structural adjustments and technological innovation in the drug industry, enhance the resilience and safety level of the industrial chain, and promote the high-quality development of the drug industry. The medical products administration under the State Council shall work in coordination with the competent authority of industry and information technology under the State Council, the competent authority of commerce under the State Council, and other relevant authorities to implement the relevant national development plans and industrial policies for the drug industry.
Chapter II Drug Development and Registration
Article 6 Entities that are engaged in drug development shall abide by the Good Laboratory Practice for Non-Clinical Laboratory Studies (GLP) and the Good Clinical Practice (GCP), ensuring that records and data are authentic, accurate, complete, and traceable.
Article 7 Non-clinical drug safety evaluation studies that are conducted for the purpose of applying for drug registration shall be carried out by accredited institutions that conduct non-clinical drug safety evaluation studies. An application for qualification accreditation as an institution that conducts non-clinical drug safety evaluation studies shall be submitted to the medical products administration under the State Council and shall be accompanied by supporting documentation that demonstrates its compliance with the GLP. The medical products administration under the State Council shall organize a review and make a decision within 20 working days of the date of acceptance of the application. Where the prescribed conditions are met, approval shall be granted and a qualification certificate shall be issued; in the case of non-compliance with the prescribed conditions, no approval shall be granted and reasons shall be given in writing.
The qualification certificate for institutions that conduct non-clinical drug safety evaluation studies shall be valid for five years. Upon expiration of the validity period, if continued conduct of non-clinical drug safety evaluation studies is required, an application for the reissuance of the qualification certificate shall be submitted.
Article 8 Sponsors of clinical drug trials shall select clinical drug trial institutions and investigators with the corresponding capabilities. They shall also fulfill responsibilities for subject protection, management of drugs for clinical trial use, clinical trial data management, and risk management.
The preparation of drugs for clinical trial use shall comply with the relevant requirements of the Good Manufacturing Practice for Pharmaceutical Products (GMP).
Sponsors of clinical drug trials and clinical drug trial institutions shall not charge subjects any fees related to the clinical trials.
Article 9 Where a change of the sponsor is proposed for a clinical drug trial that has been approved in accordance with Paragraph 1 of Article 19 of the Drug Administration Law, an application shall be submitted to the medical products administration under the State Council. The medical products administration under the State Council shall review the application and make a decision within 20 working days of the date of acceptance of the application.
Article 10 Drug development activities conducted outside the territory of China for the purpose of applying for drug registration shall comply with the relevant provisions of the Drug Administration Law, the Regulations, and other applicable laws, regulations, rules, standards, and norms; research data that are obtained outside the territory of China and meet the relevant requirements of the medical products administration under the State Council may be used for drug registration applications.
Article 11 The importation of comparator products or samples necessary for drug development or testing for registration purposes shall be subject to the approval of the medical products administration under the State Council; however, drugs for clinical trial use as specified in the clinical drug trial approval documents may be imported on the basis of such approval documents. The medical products administration under the State Council shall review the application and make a decision within 20 working days of the date of acceptance of the application.
Article 12 The development of chemical generic drugs shall be carried out in accordance with the technical requirements that are formulated by the medical products administration under the State Council, with comparator products scientifically selected for comparative studies; where reference listed drugs are designated by the medical products administration under the State Council, such reference listed drugs shall be selected as the comparator products for comparative studies.
Article 13 The development of TCM shall be guided by the TCM theory, and comprehensively evaluate the safety and efficacy of TCM based on the TCM theory, human experience in TCM use, and clinical trial data. The evaluation of the efficacy of TCM shall be consistent with its clinical positioning and reflect its characteristics.
Article 14 The development and manufacturing of TCM shall ensure the stability of the sources and quality of Chinese medicinal materials and the sustainable use of resources, and avoid adverse ecological and environmental impacts; where wild animals or plants are involved, the relevant provisions of the State shall be complied with.
Article 15 For drugs under application for registration, the medical products administration under the State Council shall carry out review and approval in accordance with Article 25 of the Drug Administration Law.
To support clinical value-oriented drug development and innovation, the medical products administration under the State Council may adopt a breakthrough therapy designation procedure, a conditional approval procedure, a priority review and approval procedure, a special approval procedure, and other measures for eligible drug registration applications to accelerate the marketing of drugs.
The medical products administration under the State Council shall establish and improve review and approval, inspection and testing, and standards management systems that accommodate the characteristics of TCM.
Article 16 When approving a drug, the medical products administration under the State Council shall review and approve its chemically active pharmaceutical ingredients concurrently; where the prescribed conditions are met, a drug registration certificate shall be issued for that drug, and an approval certificate for chemically active pharmaceutical ingredients shall be issued for the chemically active pharmaceutical ingredients. For chemically active pharmaceutical ingredients used in the manufacturing of generic drugs that have already been registered, an application for review and approval may also be submitted directly to the medical products administration under the State Council. Where the prescribed conditions are met, an approval certificate for chemically active pharmaceutical ingredients shall be issued. When reviewing and approving chemically active pharmaceutical ingredients, the medical products administration under the State Council shall concurrently approve the quality standards, manufacturing processes, and labels of such ingredients.
The transfer of a drug registration certificate or an approval certificate for chemically active pharmaceutical ingredients shall require an application to the medical products administration under the State Council. The medical products administration under the State Council shall review the application and make a decision within 20 working days of the date of acceptance of the application.
Article 17 The validity period of a drug registration certificate and an approval certificate for chemically active pharmaceutical ingredients shall be five years. Upon expiration of the validity period, where continued marketing is required, an application for re-registration shall be submitted.
A marketing authorization holder or a manufacturer of chemically active pharmaceutical ingredients shall apply for re-registration to the medical products administration of the local people's government at the provincial level; where a marketing authorization holder or a manufacturer of chemically active pharmaceutical ingredients is an overseas enterprise, it shall apply for re-registration to the medical products administration under the State Council.
Article 18 Where the circumstances for the registration of over-the-counter (OTC) drugs as specified by the medical products administration under the State Council are met, a drug registration applicant may directly submit an application for the registration of OTC drugs.
Where a marketing authorization holder of a registered prescription drug considers it suitable to be managed as an OTC drug, it may apply to the medical products administration under the State Council for its conversion to an OTC drug. Where a marketing authorization holder of a registered OTC drug, based on adverse reaction monitoring and post-marketing evaluation results, considers it unsuitable to be managed as an OTC drug, it shall apply to the medical products administration under the State Council for its conversion to a prescription drug. Where, after organizing an evaluation, the medical products administration under the State Council considers that the requirements are met, it shall decide to convert a prescription drug to an OTC drug or an OTC drug to a prescription drug, and issue a public announcement.
The medical products administration under the State Council may, based on the need to ensure public drug use safety and after organizing an evaluation, decide to convert an OTC drug to a prescription drug.
Article 19 The State shall promote the improvement in drug standards and continuously enhance the quality level of drugs.
The drug quality standards that are approved by the medical products administration under the State Council are drug registration standards. Drug registration standards shall comply with the general technical requirements of the Pharmacopoeia of the People's Republic of China and shall not be less strict than the corresponding national drug standards. A marketing authorization holder shall, in light of the formulation and revision of national drug standards, assess its drug registration standards, and where revision is necessary, revise them in a timely manner and submit a change application, or carry out filing and reporting in accordance with the provisions of the medical products administration under the State Council.
Article 20 In the development of drugs or in the application for drug registration, biological reference standards or chemical reference standards of national drugs shall be used.
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