浅析新形势下对职业化专业化药品检查员的要求

Analysis of the Requirements on Professional and Specialized Inspectors under the New Situation

作为药品监管工作的重要支撑,检查工作至关重要。《疫苗管理法》、新修订《药品管理法》及新修订《医疗器械监督管理条例》均对职业化专业化药品(含医疗器械、化妆品)检查员做出了相关规定,国家和各省(自治区、直辖市)也相继出台了具体规定,对如何成为一名合格的职业化专业化药品检查员提出了具体的要求。本文从思想品德、业务素质、专业能力、专业素养、遵纪守法、身体素质等不同方面分析和探讨了新形势下对职业化专业化药品检查员的要求。

Inspection is an essential part of drug supervision and administration.The Vaccine Administration Law,the new revised Drug Administration Law and the Regulations on Supervision and Administration of Medical Devices all include relevant provisions for professional and specialized drug(including medical devices and cosmetics)inspectors.National and provincial provisions have also been issued on how to become a qualified professional and specialized inspector.This article analyzes and discusses requirements for professional and specialized inspectors under the new situation from the aspects of personal character and integrity,professional quality and capability,discipline,and physical fitness.