中药饮片处方药与非处方药分类管理若干问题的思考

Reflections on Classification Management Issues of Prescription and Nonprescription Chinese Medicine Decoction Pieces

我国目前已初步建立了处方药与非处方药分类管理制度,但在法律法规层面长期没有明确中药饮片处方药与非处方药管理属性,造成医药实践中产生一系列监管难、处罚难、执行难的问题。在推进中医药传承与创新时代背景下,在《处方药与非处方药分类管理办法》修订的特殊时期,系统考虑中药饮片分类管理的特殊性、可行性、必要性以及制度设计科学性等问题。建议根据《药品管理法》规定的保障公众用药安全和合法权益以及药品经营许可应当遵循方便群众购药的原则,按照药品分类管理规定,在新修订的《处方药与非处方药分类管理办法》中明确中药饮片实行处方药与非处方药分类管理属性和要求。

While China has established a preliminary classification management system for prescription and nonprescription drug,there has been a long-term lack of clear regulatory attributes for prescription and nonprescription drug in traditional Chinese medicine at the legal and regulatory levels.This has resulted in a series of challenges in supervision,punishment,and enforcement in pharmaceutical practices.In the context of promoting the inheritance and innovation of Chinese medicine,and during the special period of revising the Classification and Management Measures for Prescription and Nonprescription drug,this paper systematically considers the feasibility,necessity,and scientific design of the classification management of Chinese medicine decoction pieces.It is recommended to clarify the attributes and requirements of classified management for prescription and nonprescription Chinese medicine decoction pieces in the newly revised Classification Management Measures for Prescription and Nonprescription drug.This should align with the principles of"ensuring the safety and legitimate rights and interests of the public in drug use"and"facilitating the purchase of drug by the public"stipulated in the Drug Administration Law,and adhere to the principles of drug classification management.