Reply to the proposal on further strengthening the construction of the traceability system for traditional Chinese medicines

Member Wang Rui:

 

After receiving the "Proposal on Further Strengthening the Construction of the Traceability System for Traditional Chinese Medicine" put forward, our bureau, together with the Ministry of Agriculture and Rural Affairs and the State Administration of Traditional Chinese Medicine, replied as follows:

 

The state attaches great importance to the construction of the traceability system of traditional Chinese medicine, and the Opinions of the Party Central Committee and the State Council on Promoting the Inheritance and Innovative Development of Traditional Chinese Medicine make it clear that it is necessary to explore the establishment of a traceability system for the whole process of production, circulation and use of traditional Chinese medicinal materials, pieces of traditional Chinese medicine, and proprietary Chinese medicines, and gradually realize that the source of key varieties of traditional Chinese medicine can be checked, the destination can be traced, and the responsibility can be investigated
.
The 14th Five-Year Plan for National Drug Safety and Promoting High-quality Development, the 14th Five-Year Plan for the Development of Traditional Chinese Medicine and the 14th Five-Year Plan for the Development of the National Planting Industry have made clear provisions
on the construction of traceability systems for Chinese herbal medicines, pieces of Chinese medicine and proprietary Chinese medicines.
In recent years, in order to implement the decisions and deployments of the Party Central Committee and the State Council, the State Food and Drug Administration, the Ministry of Agriculture and Rural Affairs, the State Administration of Traditional Chinese Medicine and other relevant departments have achieved positive results
in the exploration, research and construction of the traceability system of traditional Chinese medicine.

 

1.
Actively promote the construction of a quality traceability system for Chinese herbal medicines

 

The Ministry of Agriculture and Rural Affairs issued the Guiding Opinions on Accelerating the Cultivation and Development of the Entire Agricultural Industry Chain, and worked with the State Administration of Traditional Chinese Medicine, the State Food and Drug Administration and other departments to formulate the National Plan for the Construction of Local Medicinal Materials Production Bases (2018-2025), and successively launched the construction of relevant authentic Chinese herbal medicine industry clusters in 9 provinces, including Hebei, Shanxi, Jilin, Zhejiang, Anhui, Henan, Hunan, Guangxi and Gansu; Guide all localities to optimize the production layout of Chinese medicinal materials around key varieties and key links, build a number of authentic production bases of traditional Chinese medicinal materials according to local conditions, support the production bases of traditional Chinese medicinal materials to improve infrastructure and enhance industrial competitiveness
.

 

The State Administration of Traditional Chinese Medicine and the Ministry of Industry and Information Technology jointly built a supply guarantee platform for Chinese herbal medicines, implemented the quality assurance project of traditional Chinese medicines, promoted the construction of a whole-process traceability system in the main producing areas of traditional Chinese medicinal materials, and guided the construction of provincial traceability platforms in Guangxi, Guizhou, Shanghai and other places, which has now covered the whole industrial chain of enterprises in the breeding, primary processing, production, circulation and medical institutions of traditional Chinese medicinal materials, and effectively improved the quality management ability of
traditional Chinese medicines.

 

The State Food and Drug Administration strengthens the quality monitoring of Chinese medicinal materials in accordance with the law, continuously organizes annual sampling inspections of medicinal materials and pieces of traditional Chinese medicine, and regularly publishes the results of random inspections; Research and introduce measures for Chinese herbal medicine pieces manufacturers to purchase Chinese herbal medicines for processing (cutting while fresh), and guide Chinese medicine pieces to extend the quality management system to the production areas of
Chinese herbal medicines.
In March 2022, the State Food and Drug Administration, together with the Ministry of Agriculture and Rural Affairs, the State Forestry and Grassland Administration and the State Administration of Traditional Chinese Medicine
, issued the Good Manufacturing Practice for Chinese Materia Medica.
Supervise and urge Chinese medicine production enterprises to implement their main responsibilities, promote and strengthen the construction of an information traceability platform for Chinese medicinal materials, gradually realize the traceability of the whole process of planting, harvesting, processing, drying, packaging, storage and sales of traditional Chinese medicinal materials, encourage and promote the standardized development of traditional Chinese medicinal materials, and strengthen the source control
of the quality of traditional Chinese medicines.

 

Second, the construction of the information traceability system of traditional Chinese medicine has achieved results

 

In recent years, the State Food and Drug Administration has resolutely implemented the "four strictest" requirements of the general secretary on drug safety supervision, conscientiously implemented the decision-making and deployment of the Party Central Committee and the State Council, insisted on taking the supervision of Chinese medicine pieces as the starting point, extended upstream and downstream, strengthened the quality and safety supervision of the whole chain, the whole process and the whole link of traditional Chinese medicine, urged the manufacturers of traditional Chinese medicine pieces and the holders of marketing authorizations of proprietary Chinese medicines to implement the main responsibility for quality, promoted the continuous and steady improvement of the quality of traditional Chinese medicine pieces and proprietary Chinese medicines, and better guarded the bottom line of traditional Chinese medicine safety.
It has effectively guaranteed the demand for clinical services of traditional Chinese medicine and ensured that traditional Chinese medicine plays an active role
in epidemic prevention and control.

 

While strengthening the quality and safety supervision of traditional Chinese medicines, the State Food and Drug Administration has actively promoted the construction of drug information traceability system and achieved results
.
Formulate 10 technical standards related to drug traceability, such as "Guidelines for the Construction of Drug Information Traceability System" and "Requirements for Drug Traceability Code Coding", unify drug traceability standards and specifications, and put forward very specific requirements and guidance
for participants in the construction of drug traceability systems from the normative and technical perspectives of traceability data 。 The drug (vaccine) traceability collaborative service platform has been basically completed, and the interconnection and data sharing with all provincial immunization program information systems and vaccine MAHs traceability systems have been successfully realized; On this basis, a subsystem of drug coding rules and basic data filing is established to record drug coding rules and basic data including some proprietary drugs, laying a foundation
for the establishment and improvement of the information traceability system including proprietary Chinese medicines.
Organized and carried out special research on the construction of the traceability system of Chinese medicine pieces, formed the first draft of the "Code Requirements for the Traceability Code of Chinese Medicine Pieces" and the "Basic Data Set of the Identification Code of Chinese Medicine Pieces", and explored and promoted the construction of the traceability system for the whole process of
production and operation of Chinese medicine pieces.

 

In the next step, the State Food and Drug Administration, the Ministry of Agriculture and Rural Affairs, and the State Administration of Traditional Chinese Medicine will further strengthen coordination and cooperation, continue to work with relevant departments to strengthen policy guidance and support for various regions, gradually open up the traceability chain of the whole link of production, circulation and use of traditional Chinese medicine, promote the realization of "traceable source, traceable destination and accountability" of traditional Chinese medicine, and promote the high-quality development of
traditional Chinese medicine.

 

Thank you for your concern and support
in the supervision of Chinese medicines.

 

NMPA

 

August 25, 2022