Chapter I General Provisions

Article 1 In order to promote the inheritance, innovation, and development of traditional Chinese medicine, strengthen the supervision and administration of manufacturing of traditional Chinese medicines (TCMs), regulate production activities for TCMs, and improve the quality of TCMs, the Special Provision on Supervision and Administration of Manufacturing of Traditional Chinese Medicines (hereinafter referred to as the Provision) is established in accordance with the Drug Administration Law of the People's Republic of China, the Law of the People's Republic of China on Traditional Chinese Medicine, the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, the Measures for the Administration of Drug Registration, the Measures for the Supervision and Administration of Drug Manufacturing, and other relevant laws, regulations, and rules.

Article 2 The Provision shall apply to the manufacturing, supervision, and administration of traditional Chinese medicinal (TCM) prepared slices, TCM dispensing granules, Chinese proprietary medicines, TCM crude drugs under approval administration, and TCM extracts under filing management.

Article 3 The marketing authorization holder (hereinafter referred to as the MAH) and TCM manufacturer shall adhere to the principles and characteristics of traditional Chinese medicine, strictly manufacture in accordance with laws and regulations, and ensure that the entire TCM production process continuously complies with statutory requirements.

Article 4 Drug regulatory authorities shall strengthen supervision and administration over TCM manufacturing, supervise MAHs and TCM manufacturers in fulfilling their primary responsibilities for quality and safety, and ensure the safety, efficacy, and quality control of TCMs.

Article 5 The MAHs and TCM manufacturers shall be encouraged to extend their quality management systems to cover the entire production process of TCM crude drugs, ensure the quality of TCM crude drugs, accelerate the construction of high-level digital workshops, smart factories, and green factories, improve the quality control level of TCM manufacturing, and promote the digital and intelligent transformation of TCM manufacturing.

Article 6 Drug regulatory authorities shall strengthen research on TCM regulatory science, promote interdisciplinary and interdepartmental collaborative efforts, accelerate the research and application of new regulatory tools, methods, and standards for TCMs by leveraging the resources of higher education institutions and research institutes, improve the manufacturing regulatory system in line with the characteristics of TCMs, and facilitate high-quality development of the TCM industry.

Article 7 Industry associations in the field of traditional Chinese medicine shall strengthen industry self-discipline, guide and urge the MAHs and TCM manufacturers to comply with industry rules consciously, enhance integrity building, regulate product promotion, promote fair competition, and jointly foster a sound industry order in the TCM industry.

Chapter II Essential Requirements

Article 8 The manufacturing of prepared slices shall not exceed the scope of processing approved by the drug manufacturing license, and the prepared slices purchased from outside sources shall not be directly repackaged or placed on the market after merely changing their packaging or labels. Manufacturers of prepared slices shall label their products clearly, accurately, and in a standardized manner in accordance with the Provision for Labels of TCM Prepared Slices.

Where toxic drugs for medical use are used for the manufacturing of TCM prepared slices, manufacturers shall comply with the relevant laws, regulations, and provisions concerning toxic crude drugs for medical use and toxic prepared pieces.

Article 9 An application for expanding the manufacturing scope to include TCM dispensing granules shall be made by a drug manufacturer that has been approved to manufacture TCM prepared slices and granules, and that possesses complete manufacturing capabilities for processing of TCM prepared slices, extraction, separation, concentration, drying, and granulation, as well as the manufacturing capability commensurate with the number of products manufactured and marketed, and has the capability of whole-process traceability and risk management.

A manufacturer of TCM dispensing granules shall carry out by itself the processing of qualified prepared slices used for the manufacturing of TCM dispensing granules, and their descriptions and specifications shall comply with the specifications and requirements for the manufacturing of the corresponding products.

Article 10 Where TCM extracts subject to filing management are manufactured and used, the TCM extract manufacturers and the MAHs of Chinese proprietary medicines shall respectively carry out manufacturing and use filings in accordance with relevant requirements. For TCM extracts made by MAHs themselves and used only for the manufacturing of Chinese proprietary medicines within MAHs’ own enterprises, filing is not required for manufacturing or use. For a single TCM extract for Chinese proprietary medicines, the MAHs may file for more than one supplier of the TCM extract. Prior to changing a supplier that has already been filed for manufacturing, the MAHs shall conduct a study validation and quality comparison. On-site inspection shall be conducted when necessary.

Article 11 The MAHs shall organize manufacturing in accordance with the production process recognized by the drug regulatory authority. The MAHs may procure prepared slices with characteristics and specifications meeting manufacturing requirements from manufacturers or distributors of prepared slices; alternatively, the MAHs may also procure TCM crude drugs and then pre-process them for the manufacturing of Chinese proprietary medicines, including collection processed (cut while fresh) TCM crude drugs from compliant manufacturers of TCM crude drugs. The standards and processes for pre-processing or collection processing of TCM crude drugs shall comply with national drug standards for the corresponding prepared slices or Chinese proprietary medicines, or the provincial-level processing specifications for prepared slices.

For the manufacturing of compound preparations derived from ancient classic formulas, TCM manufacturers shall possess complete manufacturing capabilities for the processing of prepared slices, extraction, concentration, drying, and formulation.

Article 12 For drugs that have completed drug re-registration but have not undergone commercial-scale manufacturing during the re-registration period, the MAHs shall complete all relevant procedures strictly in accordance with the requirements of the National Medical Products Administration (NMPA) on domestic drug re-registration application procedures before resuming manufacturing.

Before resuming manufacturing of TCM injections, the MAHs shall complete post-marketing studies and evaluations as required and submit supplementary applications.

Article 13 Where the MAHs contract the manufacturing of Chinese proprietary medicines, the MAHs shall strictly perform their primary responsibilities in accordance with laws and regulations. Both the MAHs and contract manufacturers shall, in accordance with the requirements of the NMPA on the administration of contract manufacturing and contracted manufacturing of drugs, carry out tasks such as audit, research, evaluation, and reporting, and ensure the effective alignment of their quality management systems.

For contract manufacturing of TCM injections, the production heads, persons in charge of quality, and qualified persons of both the MAHs and the contract manufacturers shall have at least three years of practical experience in the manufacturing and quality management of TCM injections. The product shall have records of continuous manufacturing and marketing in the past five years without serious adverse reactions or failing sampling inspection, and the contract manufacturer shall have records of continuous manufacturing of TCM injections in the past three years.

For contract manufacturing of Chinese proprietary medicines that have not undergone commercial-scale manufacturing during the re-registration period, the MAHs shall complete the manufacturing resumption process as stipulated in Article 12 of the Provision and may proceed with contract manufacturing only after ensuring product quality stability.

Article 14 The MAHs and TCM manufacturers shall establish and implement a drug traceability system, carry out TCM product traceability through information-based means, promptly and accurately record and preserve traceability data, and improve the information-based traceability system for the whole process of manufacturing and distribution of Chinese proprietary medicines. Manufacturers of prepared slices and TCM dispensing granules shall gradually establish and improve information-based traceability systems for manufacturing and distribution, step by step and product by product. The MAHs and TCM manufacturers shall explore effective integration between information-based traceability of TCM manufacturing and distribution and information-based traceability of TCM crude drug manufacturing. The contract manufacturers shall cooperate with the MAHs to implement the drug traceability system.

Article 15 The MAHs and TCM manufacturers shall establish a pharmacovigilance system and consistently improve it, thereby strengthening the monitoring of adverse reactions, proactively conducting post-marketing studies and evaluations, and analyzing the characteristics of TCM formulas (such as the effects of processing and compatibility), and, taking into account clinical use, patient conditions, and other factors, promptly conducting comprehensive assessments of identified safety risk signals and taking effective risk control measures. The contract manufacturers shall cooperate with the MAHs in conducting pharmacovigilance activities.

Article 16 The MAHs and TCM manufacturers are encouraged to strengthen technological integration and manufacturing innovation. The MAHs and TCM manufacturers shall comprehensively apply modern science and technology, accelerate the development of manufacturing automation, digitalization, and intelligentization, and establish video-based visual monitoring capabilities in key processes such as manufacturing and inspection in an orderly manner. They are also encouraged to explore the application of online inspection and monitoring, gradually adopt information systems for real-time recording to replace traditional paper-based records, and continuously promote the transformation and upgrading of TCM manufacturing.

Chapter III Quality Management

Article 17 The internal departments of MAHs and TCM manufacturers responsible for manufacturing and quality control shall be staffed with professionals who are familiar with the properties of TCMs, and who possess the capability to identify the authenticity and quality of TCM crude drugs and prepared slices, as well as quality control capabilities. Professionals responsible for the procurement and acceptance, maintenance, storage, and processing of TCM crude drugs and prepared slices shall meet the requirements for their respective positions. Professionals involved in the processing of toxic crude drugs and other work with special requirements shall possess the necessary professional knowledge and skills and be familiar with occupational protection requirements.

The MAHs and TCM manufacturers shall designate a department or specific personnel to be responsible for training management. The training content shall align with the requirements of TCM manufacturing, emphasize traditional authentication techniques and processing techniques, and include periodic assessment of the practical competence of professionals.

Article 18 The MAHs and TCM manufacturers shall, based on the characteristics of TCMs and product attributes, apply technologies such as characteristic chromatograms, fingerprint chromatograms, and multi-component assay to conduct quality control studies of TCM crude drugs, prepared slices, intermediates, and finished products. They shall establish internal quality standards consistent with manufacturing practices, continuously update drug registration standards, and participate in the update of national drug standards and provincial-level TCM standards.

Article 19 The MAHs and TCM manufacturers shall conduct drug stability studies according to relevant requirements. When necessary, additional stability items shall be added. Based on product characteristics and historical data of stability studies, reasonable fluctuation ranges and principles for determining abnormal trends shall be recognized. When abnormal trends are identified, risk assessment shall be conducted in a timely manner, and effective control measures shall be taken.

Article 20 The MAHs and TCM manufacturers may, through quality review and risk assessment, study and establish effective quality control methods, and adopt partial testing results of bulk products for the quality evaluation of finished products. The relative testing items and their results for TCM crude drugs may be adopted for final product quality evaluation if the processing of TCM crude drugs or prepared slices does not affect the quality of TCM crude drugs and final products.

Within the same group implementing a unified quality management system, the MAHs or TCM manufacturers that use the same batch of raw materials, excipients, or packaging materials may share test results upon quality audit and risk assessment.

The data sources of the adopted or shared test results shall be clearly indicated in the testing report.

Test results shall not be adopted nor shared for TCM injections.

Article 21 The MAHs and TCM manufacturers shall complete testing of all items in accordance with the standards for marketing clearance, or adopt or share test results that meet the standards.

For testing items that involve equipment with high costs and low frequency of use, the MAHs and TCM manufacturers may contract qualified third-party testing institutions to conduct the testing. When contracting for testing, the MAHs and TCM manufacturers shall strictly comply with the relevant requirements of Good Manufacturing Practices for drugs (GMP), strengthen the review of qualifications and capabilities of the contracted testing institutions, sign contract testing agreements, take responsibility for the testing results of the contracted institutions, and report to the provincial-level drug regulatory authority at the place where they are located before carrying out the contracted testing.

Within the same group implementing a unified quality management system, the MAHs or TCM manufacturers may share testing equipment with high costs and low frequency of use, with implementation by reference to the contracted testing approach.

Article 22 The MAHs and TCM manufacturers shall conduct periodic quality reviews of the entire TCM production process, with emphasis on the impact of fluctuations in the quality of TCM crude drugs on extraction yield, the content of active ingredients or marker components, and other factors, assess the effectiveness of internal quality standards in controlling the quality of raw materials, excipients, and finished products, promptly carry out study validation, improve and enhance the level of quality control, and ensure stable and reliable processes.

Chapter IV Material Management

Article 23 MAHs and TCM manufacturers shall conduct quality evaluations on the procured TCM crude drugs to ensure that they meet the requirements for medication use, with accurate origin of TCM crude drugs, clear source, definite place of origin, and standardized processing and storage. Where the drug approval documents require a fixed origin of TCM crude drugs, the origin of TCM crude drugs shall be fixed. Using wild TCM crude drugs or imported TCM crude drugs, effective measures shall be taken to ensure a fixed origin of crude drugs, stable quality, and effective control of the risk of contamination by exogenous hazardous substances. For the manufacturing of TCM injections, raw materials shall comply with the requirements of Good Agricultural Practice for TCM Crude Drugs (GAP for TCM Crude Drugs). For the manufacturing of TCM dispensing granules, raw materials are recommended to comply with the requirements of Good Agricultural Practice for TCM Crude Drugs (GAP for TCM Crude Drugs).

When using Dao-di TCM crude drugs, TCM crude drugs that comply with the requirements of GAP for TCM crude drugs, or TCM crude drugs directly procured from TCM crude drug manufacturers at the place of origin, the MAHs or TCM manufacturers may, upon review during quality audit, refer to materials such as the origin identification and quality testing results of the TCM crude drugs, and the source of the referenced materials shall be indicated.

Article 24 MAHs and TCM manufacturers shall procure collection-processed (cut while fresh) TCM crude drugs from manufacturers at the place of origin with a mature quality management system. The procured TCM crude drugs (cut while fresh) shall be the products listed by the provincial-level drug regulatory authority at the place of origin. MAHs and TCM manufacturers shall guide and urge TCM crude drug manufacturers at the place of origin to establish a complete traceability system for TCM crude drugs.

Article 25 MAHs and TCM manufacturers shall strengthen the audit of raw material suppliers. During procurement and use, quality evaluation shall be conducted regularly based on the results of annual reviews, and on-site inspections shall be conducted regularly for suppliers of major raw materials; when necessary, on-site inspections shall be conducted on the cultivation and breeding, harvesting and processing, storage, and transportation of TCM crude drugs. MAHs and TCM manufacturers shall establish complete audit files for suppliers.

Article 26 MAHs and TCM manufacturers shall categorize the procured TCM crude drugs based on their source, supplier, and crude drug specifications, divide them into batches, and assign batch numbers. TCM crude drugs from the same supplier and origin of crude drugs, the same cultivation and breeding base, with the same growth cycle, and with consistent ecological environment and conditions, harvesting time, and processing methods at the place of origin, as well as with uniform quality, may be recognized as the same batch.

Article 27 MAHs and TCM manufacturers shall establish and effectively implement acceptance management procedures to ensure that raw materials, excipients, and packaging materials are accepted and stored in the warehouse only after being confirmed to comply with the standards and medicinally-used requirements. The acceptance management procedure shall incorporate traditional experience-based identification methods.

MAHs and TCM manufacturers shall test by batch on each procurement of raw materials, excipients, and packaging materials. For TCM crude drugs complying with the requirements of GAP purchased in batches under the same batch number, after the first procurement passes full-item testing, partial-item testing may be conducted for subsequent procurements based on quality risk assessment.

MAHs and TCM manufacturers shall also check whether the content of the labels and marks on the raw material packages is complete and complies with the relevant regulations. For TCM crude drugs and prepared slices subject to special mark requirements, such as toxic drugs for medical use and narcotic drugs, they shall also check whether their package labels are printed with the special marks in compliance with the relevant regulations.

Article 28 MAHs and TCM manufacturers shall define maintenance measures and storage periods for various raw materials according to their characteristics, specify the re-test period or shelf life, and transport, store, and maintain the raw materials according to relevant requirements.

Article 29 MAHs or TCM manufacturers shall review and evaluate the origin of TCM crude drugs, place of origin, harvesting and processing of the imported TCM crude drugs, and the qualification of the import enterprise when using imported TCM crude drugs for TCM manufacturing. Materials such as copies of the original certification documents, testing reports of the imported TCM crude drugs, and copies of the customs clearance documents for the imported drugs shall be included in the supplier review files.

Article 30 MAHs or TCM manufacturers shall prepare special facilities and equipment according to relevant requirements. Strict management systems, operating procedures, dedicated storage, detailed records and product traceability shall be applied to prevent their illegal use for use of TCM raw materials managed as toxic drugs for medical use, narcotic drugs, etc., and for the manufacturing of Ephedra Herba dispensing granules, the source, processing, transportation, storage, procurement, acceptance, and manufacturing of such TCM raw materials shall comply with the laws and regulations.

Article 31 MAHs or TCM manufacturers where TCM crude drugs of wild fauna, flora or fossils are used, the relevant laws and regulations of the state on the protection of wild animals, plants, and fossils shall be complied with, and the legality and compliance of the source and processing shall be ensured. Special ledgers shall be established with consistency between the accounts and the actual inventory shall be maintained.

Chapter V In-process Control

Article 32 MAHs and TCM manufacturers shall establish manufacturing instructions in accordance with the GMP and its annexes. The instructions shall comply with the national drug standards, drug registration standards, or provincial-level TCM standards and the production process recognized by the drug regulatory authority. MAHs and TCM manufacturers shall specify key process parameters, determine a reasonable yield range, and prevent contamination, cross-contamination, mix-ups, and errors.

For the manufacturing of TCM injections, the process parameters and quality control requirements for the entire production process shall also be specified and detailed.

Article 33 MAHs and TCM manufacturers shall carry out process validation in accordance with the requirements, which may be conducted in stages according to the extraction process and the preparation process. The process validation of prepared slices shall also integrate the judgment standards of traditional attributes.

Where process re-validation involves multiple identical manufacturing lines, one representative manufacturing line may be selected for validation after risk assessment, and the validation process shall reflect actual manufacturing conditions.

Article 34 Chinese proprietary medicines shall be manufactured strictly in accordance with the composition and quantity of the ingredients in the formulas as specified in the national drug standards, drug registration standards, and the drug production process recognized by the drug regulatory authorities. Before feeding, TCM crude drugs and prepared slices shall be subjected to purification treatment as required; if directly fed after washing, the feeding amount shall be calculated according to the drying conversion rate to ensure the feeding amount is in compliance with specified ingredients in formulas.

Article 35 MAHs and TCM manufacturers may, with reference to the Technical Guidelines for the Study of TCM Homogenization, conduct research and demonstration based on product characteristics, drug standards, production processes, manufacturing data, and validation data, establish operating procedures, and charge after conducting homogenization treatment of raw materials.

Raw materials subjected to homogenization treatment shall be manufactured in compliance with standards and meet quality requirements. Homogenization operations shall have complete records to ensure authenticity, integrity, and traceability.

Article 36 Measures shall be taken in each stage of the TCM production process to reduce microbial load, and strict in-process control and appropriate sterilization methods shall be applied to ensure that the microbial limits meet the requirements.

Where the national drug standards for Chinese proprietary medicines, drug registration standards, or drug production processes approved by the drug regulatory authority do not explicitly specify sterilization processes, but such sterilization processes have already been practically applied in the manufacturing of Chinese proprietary medicines, and, in accordance with the Provision on Post-marketing Changes of Drugs, are not subject to re-submission, the MAHs shall improve research and validation, specify them in the production process procedures, and report through the annual drug report.

Article 37 Where deviations exist in the yield of TCM extract, the MAHs shall, on the basis of stable origin of crude drugs, place of origin, TCM crude drugs, and prepared slices, optimize the extraction process parameters of TCMs, define the yield ranges of the extract and finished products, specify them in the production process procedures, and report through the annual drug report. If the yield exceeds the defined ranges, the MAHs shall promptly conduct a deviation investigation, carry out risk assessment on product quality, conduct research and validation with reference to the relevant technical guidelines for registration or post-marketing change management of TCMs, and perform filing, submit supplementary applications, or registration applications in accordance with the regulation.

Article 38 MAHs and TCM manufacturers may establish pretreatment and extraction workshops at different locations, or share pretreatment and extraction workshops with drug manufacturers within the same group that implement a unified quality management system, after signing a quality agreement. The above provision shall not apply to drug manufacturers engaged in the contract manufacturing of Chinese proprietary medicines.

MAHs and TCM manufacturers shall implement unified management of off-site or shared workshops, establish feasible manufacturing and quality management measures, establish strict quality control standards, and manage the entire production process of pretreatment and extraction in such off-site or shared workshops to ensure compliance with the drug standards and the production process approved or filed by the drug regulatory authority.

Article 39 The solvents used for TCM extraction and their quantities shall comply with the national drug standards for Chinese proprietary medicines, drug registration standards, and the production process approved by the drug regulatory authority. Where the solvent quantity is not explicitly specified, it shall, in principle, be calculated according to the weight ratio of the charging quantity. Where TCM extraction solvents need to be recycled for use, quality studies shall be conducted on the recycled solvents, risks such as cross-contamination and residues of medicinal substances shall be assessed, the number of recycling times shall be determined, operating procedures and quality standards for solvent recycling shall be established, and the recycled solvents shall be ensured to meet the requirements for reuse. In principle, the recycled solvents shall not be used for other products.

Article 40 MAHs and TCM manufacturers shall establish management systems and operating procedures for the disposal of medicinal residues, designate management organizations and responsible personnel, and prevent the illegal use of extracted medicinal residue waste. Where temporary storage of medicinal residue waste is required, dedicated areas shall be designated. MAHs and TCM manufacturers are encouraged to carry out comprehensive research and utilize green recycling of TCM resources.

Chapter VI Supervision and Administration

Article 41 Drug regulatory authorities shall be staffed with inspectors who meet the needs of TCM regulation, are familiar with the laws, regulations, and technical requirements for the regulation of the manufacturing of TCM crude drugs, prepared slices, and Chinese proprietary medicines, and shall strengthen training in TCM expertise and inspection skills.

Article 42 Where MAHs and TCM manufacturers establish or share pretreatment and extraction workshops at different locations, approval shall be obtained from the provincial-level drug regulatory authority at the location of the MAH or TCM manufacturer. Where such workshops are established across provinces (autonomous regions or municipalities), prior consent shall also be obtained from the provincial-level drug regulatory authority at the location of the workshop. The address of the workshop shall be specified on the Drug Manufacturing License of the MAH or TCM manufacturer; for shared workshops, the drug manufacturing licenses of both parties shall also specify the attribution and the name of the shared enterprise.

The provincial-level drug regulatory authority at the location of the MAH or TCM manufacturer shall be responsible for the regulation of the production process of the relevant products in such off-site or shared workshops. For the regulation of off-site or shared workshops established across provinces (autonomous regions or municipalities), the provincial-level drug regulatory authority at the location of the MAH or TCM manufacturer may conduct it independently, jointly, or request the provincial-level drug regulatory authority at the location of the workshop to conduct it. The provincial-level drug regulatory authority at the location of the workshop shall be responsible for the routine supervision of the pretreatment and extraction in such off-site or shared workshops.

Article 43 Drug regulatory authorities shall, based on products, dosage forms, management categories of TCMs, and risk factors such as previous inspections, sampling inspections, adverse reaction monitoring, and complaints and reports, comprehensively take into account whether MAHs and TCM manufacturers proactively implement GAP for TCM crude drugs, carry out intelligent manufacturing transformation, and establish whole-chain traceability. MAHs and TCM manufacturers shall be classified into risk levels, regulatory resources shall be scientifically allocated, and differentiated and precise supervision shall be implemented.

Article 44 Provincial-level drug regulatory authorities shall conduct supervision and inspection of MAHs and TCM manufacturers within their administrative regions, and, when necessary, carry out extended inspections of suppliers of raw materials, excipients, packaging materials, as well as contracted testing institutions.

Provincial-level drug regulatory authorities shall adhere to the principles of risk management and whole-process control, focus on the procurement of raw materials such as TCM crude drugs, formula, production processes, charging, and release inspection in light of the actual situation and characteristics of TCM manufacturing, and supervise MAHs and TCM manufacturers to conduct manufacturing in compliance with laws and regulations continuously.

Article 45 Drug regulatory authorities shall, in light of the actual regulatory circumstances within their administrative regions, strengthen sampling inspection of TCM products, and, when necessary, conduct sampling inspection of raw materials, excipients, and packaging materials. According to regulatory needs, inspection results shall be comprehensively analyzed, potential risks shall be assessed, and preventive and control measures shall be taken in accordance with the law.

Article 46 Where drug regulatory authorities find that MAHs or TCM manufacturers have engaged in illegal acts such as adulteration or fraud, or have failed to comply with GMP requirements in aspects such as quality management systems, material management, supplier audits, or in-process control, they shall, in accordance with the law, impose strict penalties; where a suspected crime is involved, the case shall be promptly transferred to the public security authorities.

Article 47 Provincial-level drug regulatory authorities shall strengthen coordination and cooperation, and enhance the sharing of regulatory information, such as inspections, testing, monitoring, and penalties. Where cross-provincial-level (autonomous region or municipality) extended inspections of TCM crude drug cultivation and breeding bases, TCM crude drug manufacturers, or contracted testing institutions are required, the provincial-level drug regulatory authority at the location of the MAH or TCM manufacturer may request the provincial-level drug regulatory authority at the location of the inspected institution to render assistance in conducting the inspection.

Article 48 Where provincial-level drug regulatory authorities discover that TCM crude drugs, prepared slices, or TCM extracts may involve quality issues related to upstream or downstream products, they shall promptly notify the provincial-level drug regulatory authorities at the locations of the relevant upstream and downstream enterprises, and, when necessary, proactively strengthen communication and coordination with departments at the same level, such as agriculture and rural affairs, market regulation, healthcare security, and Traditional Chinese Medicine administration.

Chapter VII Supplementary Provisions

Article 49 The term "TCM manufacturers" as used in the Provision refers to drug manufacturers engaged in the manufacturing of TCMs (including TCM prepared slices, TCM dispensing granules, Chinese proprietary medicines, and TCM crude drugs subject to approval administration) that have legally obtained the Drug Manufacturing License. Manufacturers of TCM extracts that have completed filing procedures shall be managed in reference to the requirements applicable to TCM manufacturers under the Provision.

Article 50 The term "raw materials" as used in the Provision refers to TCM crude drugs used for the manufacturing of prepared slices, as well as TCM crude drugs, prepared slices, or TCM extracts subject to filing management used for the manufacturing of Chinese proprietary medicines. Raw materials shall comply with medicinal use requirements and the relevant requirements of GMP.

Article 51 The term "TCM crude drugs" as used in the Provision refers to medicinal raw materials derived from resources such as medicinal plants, medicinal animals, or minerals, which are used for the manufacturing of prepared slices, TCM dispensing granules, Chinese proprietary medicines, and TCM extracts subject to filing management.

Article 52 The term "TCM crude drug manufacturers" as used in the Provision refers to enterprises engaged in the cultivation and breeding, harvesting and collection, and collection processing of TCM crude drugs, including planting and breeding professional cooperatives or associations with the nature of enterprises.

Article 53 The term "TCM extracts subject to filing management" as used in the Provision refers to volatile oils, fats and oils, extracts, fluid extracts, dry extracts, active ingredients, active parts, and other components that are specified in the formula of the national drug standards for Chinese proprietary medicines, have separate national drug standards, and are used for the charging and manufacturing of Chinese proprietary medicines.

Article 54 The term "Traditional Chinese Medicine" as used in the Provision includes the traditional medicine of ethnic minorities, and the term "Traditional Chinese Medicines" includes the traditional medicines of ethnic minorities.

Article 55 The Provision shall come into force as of March 1, 2026.