我国兽药监管制度问题研究

Research on problems of veterinary drug regulatory system in China

我国兽药监管制度经历了行政指令时期、法制化时期、兽药生产质量管理规范(兽药GMP)监管时期、兽药市场全面整顿时期以及绿色、生态、减抗时期5个阶段的变迁。虽然兽药监管制度不断完善,为畜牧业健康发展奠定了坚实的基础,但目前仍存在四方面的问题:一是地区及部门间监管协调机制缺乏,监管盲区仍然存在;二是部门间专门法律缺位,部分标准尚待细化;三是生产准入制度尚需健全,准入门槛亟待提高;四是激励机制缺乏,企业创新外生动力不足。因此,必须大力推进相关机构的职责整合,进一步明确药政、药监、药检三方职责;细化相关法律法规,完善兽医服务体系建设;严格实施"4G"制度,加快兽药残留监控网络建设;鼓励构建研发平台,加强"产、学、研"三方合作。

Veterinary drug regulatory system in China has undergone five stages of changes: administrative instruction period, legalization period, good manufacturing practice for veterinary drug(GMP veterinary drug) supervision period, comprehensive reorganization period of veterinary drug market period and green, ecological, and reduce the use of antibiotics period. Although the veterinary drug regulatory system has been constantly improved, which has laid a solid foundation for the healthy development of animal husbandry, there are still four main problems. First, there is a lack of regulatory coordination mechanism between regions and departments, and regulatory blind spots still exist. Second, there is a lack of specialized laws between departments, and some standards need to be refined. Third, the production access system need to be improved and admittance threshold needs to be raised. Fourth, There is a lack of incentive mechanism and exogenous impetus for enterprise innovation. Therefore, it is necessary to vigorously promote the integration of the responsibilities of relevant agencies, and further clarify the responsibilities of drug administration, drug supervision, and drug inspection. Relevant laws and regulations should be refined to improve the construction of the veterinary service system. It should strictly implement the "4 G" system and accelerate the construction of the veterinary drug residue monitoring network. It is encouraged to build a research and development platform, and strengthen cooperation among industries, universities and research institutes.