Announcement on the Conclusion of the Pilot Program for Traditional Chinese Medicine Compound Granules

National Medical Products Administration National Administration of Traditional Chinese Medicine National Health Commission National Healthcare Security Administration

Announcement on the Termination of the Pilot Program for Traditional Chinese Medicine Compound Granules

（2021year22No.)

Release Date:2021-02-10

　　In order to strengthen the management of traditional Chinese medicine compound granules, standardize the production of traditional Chinese medicine compound granules, guide the healthy development of the industry, and better meet the clinical needs of traditional Chinese medicine, it has been decided to terminate the pilot program for traditional Chinese medicine compound granules after research. The relevant matters are hereby announced as follows:

　　I. Traditional Chinese medicine compound granules are granules made from single-flavor traditional Chinese medicine slices through water extraction, separation, concentration, drying, and granulation. Under the guidance of traditional Chinese medicine theory, they are dispensed according to traditional Chinese medicine clinical prescriptions for patients to take orally. Quality supervision of traditional Chinese medicine compound granules is included in the management of traditional Chinese medicine slices.

　　II. The varieties of traditional Chinese medicine compound granules implement filing management, not approval number management. Before listing, the production enterprises shall file with the provincial drug supervision and administration departments where they are located.

　　III. Traditional Chinese medicine production enterprises producing traditional Chinese medicine compound granules shall obtain a "Pharmaceutical Production License" and simultaneously have the production scope of traditional Chinese medicine slices and granules. Traditional Chinese medicine compound granule production enterprises shall have complete production capabilities such as traditional Chinese medicine processing, extraction, separation, concentration, drying, and granulation, and shall have production scales corresponding to the number of varieties they produce and sell. Production enterprises shall process the traditional Chinese medicine slices used in the production of traditional Chinese medicine compound granules by themselves.

　　IV. Enterprises producing traditional Chinese medicine compound granules shall fulfill their main responsibilities and related obligations throughout the life cycle of the drug, implement full-process production management, establish a traceability system, gradually realize traceable sources and destinations, and strengthen risk management. The production process of traditional Chinese medicine compound granules, including the processing, water extraction, separation, concentration, drying, and granulation of traditional Chinese medicine slices, shall comply with the relevant requirements of Good Manufacturing Practice for Pharmaceutical Products (GMP) . For the traditional Chinese medicinal materials needed to produce traditional Chinese medicine compound granules, those that can be artificially planted and raised should prioritize the use of traditional Chinese medicinal materials from traditional Chinese medicinal material planting and breeding bases that meet the requirements of Good Agricultural and Collection Practice for Traditional Chinese Medicine. It is advocated to use authentic medicinal materials.

　　V. Provincial drug supervision and administration departments, together with provincial TCM authorities, shall formulate corresponding management rules in accordance with relevant provisions of national and local industrial policies and actual clinical needs, upholding the leading position of traditional Chinese medicine slices, and ensuring the steady and orderly development and rational and standardized use of traditional Chinese medicine compound granules in their jurisdiction.

　　Provincial drug supervision and administration departments shall consolidate their local regulatory responsibilities. Undertake the filing work of traditional Chinese medicine compound granules within their administrative regions. Strengthen the management during and after the event, strengthen inspection, spot checks and monitoring, implement extended inspections of standardized planting and breeding bases of traditional Chinese medicinal materials, and deal with illegal and irregular behaviors.

　　VI. Traditional Chinese medicine compound granules shall be produced in accordance with the filed production processes and shall conform to national drug standards. Where not stipulated by national drug standards, they shall conform to the standards formulated by the provincial drug supervision and administration departments. Provincial drug supervision and administration departments shall, after formulating their standards,30within days, submit the standard approval documents, standard texts, and compilation notes to the National Pharmacopoeia Committee for the record. Traditional Chinese medicine compound granules without national drug standards or standards formulated by provincial drug supervision and administration departments shall not be marketed.

　　VII. The National Pharmacopoeia Committee shall organize the review and approval of national drug standards for traditional Chinese medicine compound granules based on the experience of the pilot program and announce them in batches. The standards formulated by provincial drug supervision and administration departments shall comply with the provisions of "Technical Requirements for Quality Control and Standard Formulation of Traditional Chinese Medicine Compound Granules". After the national drug standards for traditional Chinese medicine compound granules are promulgated and implemented, the corresponding standards formulated by provincial drug supervision and administration departments shall be abolished.

　　VIII. For the inter-provincial sale and use of traditional Chinese medicine compound granules, the production enterprises shall file with the provincial drug supervision and administration departments of the place of use. Traditional Chinese medicine compound granules without national drug standards used across provinces shall comply with the standards formulated by the provincial drug supervision and administration departments of the place of use.

　　IX. Traditional Chinese medicine compound granules shall not be sold outside medical institutions. Traditional Chinese medicine compound granules used by medical institutions shall be purchased through transparent procurement and online transactions on the provincial centralized procurement platform for drugs. They shall be directly delivered by the production enterprises, or delivered by the production enterprises entrusting pharmaceutical business enterprises with storage and transportation conditions. Enterprises receiving the delivery of traditional Chinese medicine compound granules shall not entrust the delivery. Medical institutions shall sign quality assurance agreements with production enterprises.

　　X. For traditional Chinese medicine slices that have been included in the medical insurance payment scope, provincial medical insurance departments can comprehensively consider clinical needs, fund payment capacity, Price and other factors, and after expert review, include traditional Chinese medicine compound granules corresponding to traditional Chinese medicine slices into the payment scope, and refer to Category B management.

　　XI. Dispensing equipment for traditional Chinese medicine compound granules shall conform to the habits of traditional Chinese medicine clinical medication, shall effectively prevent errors, pollution and cross-contamination, and materials directly in contact with traditional Chinese medicine compound granules shall meet pharmaceutical requirements. The dispensing software used shall make the dispensing process traceable.

　　XII. Labels directly contacting the packaging of traditional Chinese medicine compound granules shall at least indicate the filing number, name, execution standard of traditional Chinese medicine slices, execution standard of traditional Chinese medicine compound granules, Specification, production date, product batch number, shelf life, storage, production enterprise, Address, contact information, etc.

　　XIII. This announcement shall come into effect from2021year11month1day. Upon the commencement of this announcement, the "Notice on Issuing the Provisional Regulations on the Management of Traditional Chinese Medicine Compound Granules" (Guoyaojianzhu [2001]325No.) shall be repealed. Policies on the clinical use of traditional Chinese medicine compound granules shall be separately studied and formulated or clarified by relevant departments.

　　This is hereby announced.

　　National Medical Products Administration National Administration of Traditional Chinese Medicine

　　National Health Commission     National Healthcare Security Administration

2021year2month1Date