The State Food and Drug Administration issued the "Special Regulations on Supervision and Administration of Traditional Chinese Medicine Production"
Recently, the State Drug Administration officially issued the "Special Regulations on the Supervision and Administration of Traditional Chinese Medicine Production" (hereinafter referred to as the "Regulations"), aiming to further standardize the production behavior of traditional Chinese medicine, ensure the quality and safety of drugs, and promote the high-quality development of the traditional Chinese medicine industry. The "Regulations" will be implemented from the date of their publication and become an important regulatory basis for the field of traditional Chinese medicine production.
1. Background of the Issuance of the Regulations
In recent years, the traditional Chinese medicine industry has developed rapidly, but some traditional Chinese medicine manufacturers have problems such as irregular quality management and poor production process standards, which has affected the safety and effectiveness of traditional Chinese medicine products. In order to strengthen the supervision of the entire process of traditional Chinese medicine production, the State Food and Drug Administration has formulated the "Special Regulations on Supervision and Administration of Traditional Chinese Medicine Production" based on extensive research and soliciting opinions to improve the traditional Chinese medicine production supervision system.
2. Main content and requirements
The "Regulations" are divided into six chapters, including general provisions, production licensing and filing, production process management, supervision and management, legal liability and appendix, with the main contents as follows:
| chapter | Core content |
|---|---|
| Chapter 1 General Provisions | Clarify the scope of application, regulatory principles and division of responsibilities of the "Regulations". |
| Chapter 2 Production License and Registration | Refine the licensing conditions, filing requirements and change procedures of traditional Chinese medicine manufacturers. |
| Chapter 3 Production Process Management | Emphasize the specifications and requirements for raw material procurement, production process, quality control and other links. |
| Chapter 4 Supervision and Management | Clarify the specific implementation of supervision measures such as supervision and inspection, flight inspection, and random inspection. |
| Chapter 5 Legal Liability | Regulations on penalties for illegal and irregular acts, including fines, production suspension and rectification. |
| Chapter 6 Attachment | Explain the right to interpret and implement the "Regulations". |
III. Key regulatory measures
1.Strengthen source management: Enterprises are required to establish a traceability system for traditional Chinese medicinal materials to ensure that the source of raw materials is verified and the quality is controllable.
2.Standardize production process: Clarify the technical standards for the production of traditional Chinese medicine preparations, and it is prohibited to change the process parameters without authorization.
3.Strengthen quality inspection: The company is required to conduct full inspection of each batch of products and keep inspection records.
4.Improve the recall system: For products with safety hazards, enterprises must actively recall and report to the regulatory authorities.
4. Industry impact analysis
The release of the "Regulations" will have a profound impact on the traditional Chinese medicine industry:
| Influence objects | Specific impact |
|---|---|
| Traditional Chinese medicine manufacturer | We need to increase quality investment and optimize production processes, and some small and medium-sized enterprises may face elimination. |
| Chinese medicinal materials supplier | The standards for planting and primary processing need to be improved to meet the traceability requirements of the enterprise. |
| consumer | The quality of traditional Chinese medicine products will be more reliable, but the prices of some products may rise. |
| Regulatory departments | The regulatory responsibilities are clearer and the basis for law enforcement is more sufficient. |
5. Expert interpretation
Li Ming, vice president of the China Association of Traditional Chinese Medicine, said: "The introduction of the "Regulations" fills the gap in the supervision of traditional Chinese medicine production and helps to improve the overall level of the industry. Enterprises should take this as an opportunity to accelerate transformation and upgrading." Professor Zhang from Beijing University of Traditional Chinese Medicine pointed out: "The new regulations particularly emphasize process management, which is in line with the concept of international drug production and will promote the internationalization of traditional Chinese medicine."
6. Implementation Outlook
The State Food and Drug Administration stated that it will organize the national drug supervision system to carry out special training to ensure that the "Regulations" are implemented in place. At the same time, credit files of traditional Chinese medicine manufacturers will be established, policy support will be provided to compliant enterprises, and penalties will be increased for violating enterprises. It is expected that in the next three years, the traditional Chinese medicine industry will usher in a round of in-depth adjustments, and high-quality enterprises will gain greater room for development.
The release of the "Special Regulations on the Supervision and Administration of Traditional Chinese Medicine Production" marks the entry of a new stage of traditional Chinese medicine supervision in my country and is of great significance to ensuring the safety of public drug use and promoting the inheritance, innovation and development of traditional Chinese medicine.
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