摘要
药用辅料是影响药品质量、安全性和有效性的重要成分。该文在分析我国药用辅料管理现状的基础上,结合该省注册监管的实际情况对国家食品药品监督管理总局出台的《加强药用辅料监督管理有关规定的通知》进行进一步解读,并对完善药用辅料的监督管理提出了一些思考和完善措施,以期为监管部门和企业提供有效参考。
Pharmaceutic adjuvant is the impact of drug quality, safety and effectiveness of important components.Based on the analysis of management status of pharmaceutic adjuvant of our country,Combined with the actual situation of the province registered supervision, the State Food and Drug Supervision Administration issued《 strengthening the supervision and management of pharmaceutic adjuvant relevant provisions of the notice》further reading,And some thinking and improvement measures are put forward to improve the supervision and administration of pharmaceutic adjuvant,In order to provide effective reference for the regulatory authorities and enterprises.
出处
《中国卫生产业》
2015年第5期70-72,共3页
China Health Industry
关键词
药用辅料
监督管理
供应商审计
备案
Pharmaceutic adjuvant
Supervision and administration
Supplier audit
Keep on record
