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Provisions Developed by the National Medical Products Administration to Strengthen the Administration of Standards for Traditional Chinese Medicines
    Pubtime: 2024-07-17

  On July 04, Li Li, Party Secretary and Director of the National Medicinal Products Administration (NMPA), presided over the conference to study and deploy the work of strengthening the administration of standards for traditional chinese medicines (TCMs), and reviewed and approved the Special Provisions on the Administration of Standards for Traditional Chinese Medicines.

  The conference pointed out that the TCM standards are mandatory technical provisions formulated or approved by the drug regulatory department to ensure the quality of TCMs, serving as a critical foundation for ensuring the safety and effectiveness of TCMs. As an important method for the regulation of TCMs, these standards play a fundamental and leading role in the regulation work of TCMs. The Special Provisions on the Administration of Standards for Traditional Chinese Medicines focuses on the establishment of "the most stringent standards", and makes provisions from the policy and technical levels, respectively. Combining the general requirements for the administration of drug standards with the characteristics of TCM products, it stipulates the basic principles for the research and formulation of TCM standards, the specific requirements for various types of TCM specification, the revision and implementation of standards, etc. Additionally, it clarifies the responsible entities and standardizes the key processes involved in TCM standard administration.

  The Special Provisions on the Administration of Standards for Traditional Chinese Medicines will come into force on January 01, 2025. Subsequently, the NMPA will organize publicity and training to further standardize and improve the capacity and level of TCM standard administration.

  (Excerpt from: National Medical Products Administration website 2024-07-04)

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