State Drug Administration, Traditional Chinese Medicinal Materials Good Agricultural Practice (Trial Implementation)
国家药品监督管理局中药材生产质量管理规范 (试行)
June 02, 2002 | BY
clpstaff &clp articles &Governs all aspects of Chinese medicine production, including quality control, environmental protection, packaging, transportation and storage, personnel and document management.
Issued: April 17 2002
Effective: June 1 2002
Interpreting authority: State Drug Administration
Applicability: This Practice applies to the entire production process of traditional Chinese medicinal materials (Article 2). For the purposes of the Practice, "traditional Chinese medicinal materials" means crude medicinal materials resulting from preliminary processing of the efficacious parts of plants and/or animals at the place of origin (Article 55).
Main contents: The Practice requires producers of traditional Chinese medicinal materials to adopt standardized management and quality control measures, protect the resources of wild medicinal materials and their ecological environment and observe the principle of "maximum sustainable production" to ensure sustainable availability of such resources (Article 3). The Practice contains ten parts and covers these areas: the ecological environment of production sites (Part Two); variety quality and breeding materials (Part Three); cultivation and breeding management (Part Four); collection and preliminary processing (Part Five); packaging; transportation and storage (Part Six); quality management (Part Seven); personnel and equipment (Part Eight); and document management (Part Nine). Part Ten provides the definitions of certain terms used in the Practice.
Related legislation: PRC, Administration of Pesticides Regulations
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