《中药材生产质量管理规范》修订背景及主要修订内容

为更好地理解和贯彻新发布的《中药材生产质量管理规范》（以下简称新版中药材GAP）、促进中药材GAP规范化生产基地建设、推动中药高质量发展，浅谈新版中药材GAP修订背景、过程、主要修订思路、业界关注重点问题的处理及需要进一步细化的内容。新版中药材GAP共14章144条，较试行版中药材GAP增加了4章87条；修订中贯彻的主要思路包括强调对中药材质量有重大影响的关键环节实施重点管理、重视全过程细化管理、以“六统一”和“可追溯”树立风险管控理念；强调高标准、严要求、兼顾中药材生产实际情况及当前技术水平；贯彻“写我要做、做我所写、记我所做”理念，将技术规程和质量标准制定前置；立足中医药特色和传承，鼓励采用适宜的新技术、新方法；强调药材规范生产与生态环境保护统一；强化药材流向管理，补充了放行、投诉、退货与召回等管理内容。修订中，重点关注的问题包括新版中药材GAP的适用范围，“六统一”，生产组织方式，产地，种质，农药使用，壮根灵、膨大素等生长调节剂的使用，硫黄熏蒸与磷化铝熏蒸，技术规程与标准操作规程，中药材生产质量追溯体系，批等。

Revision Background and Main Contents of Good Agricultural Practice for Traditional Chinese Medicinal Materials

In order to facilitate understanding the recently released Good Agricultural Practice for Traditional Chinese Medicinal Materials (new version GAP, nGAP), this paper analyzes the revision background, process, main ideas of revisions and treatment of key concerns for nGAP, which is expected to promote the construction of GAP base of traditional Chinese medicinal materials (TCMM) and high-quality development of traditional Chinese medicine (TCM). Those needed to be further refined in the Guide of the new version GAP are also discussed. nGAP is composed of 14 chapters and 144 articles, with 4 chapters and 87 articles added compared with the trial version GAP. The main ideas implemented in the revision are illustrated as follows. Importance is attached to detailed management of the whole process and key management on crucial links that impact the quality of TCMM, and the risk control concept of "six unification" and "traceability" is established. High standards and strict requirements are combined with the current situation and technical levels of TCMM production. Technical regulations and quality standards are formulated in advance by implementing the idea of "planning-implementing-review". Given the characteristics and inheritance of TCM, new technologies and new methods are encouraged. Standardized production of TCMM is unified with ecological environment protection. Moreover, goods direction management of TCMM is strengthened, and management contents such as release, complaint, return and recall of TCMM are added. Some key concerns in nGAP are as follows: the applicable targets of nGAP, "six unification", production and organization model, production sites, germplasm, pesticide use, the use of growth regulators, fumigation of sulfur and aluminum phosphide, technical procedures and standard operating procedures, production quality traceability system, batch, etc.