title: To Set Up Norms for Drug Safety and Inspection: To Guarantee Administrative Sufficiency and Avoid Regulators from Being Wrongly Punished.
abstract: Currently, as there is no systematic norm or standard for drug safety and inspection, it cannot be judged whether the regulatory authority or regulators have fulfilled their administrative responsibilities entirely or not, when a drug safety-related incident occurs. And there is a probability that some may even be wrongly punished. In this study, we have analyzed the risk of not having appropriate norms in place and also put forward recommendations for the government or the regulatory authorities to set up norms to be fulfilled for drug safety and inspection issues. This, on one hand, could provide a basic guideline for the regulatory authorities and regulators to improve their professional levels and administrative acumen and on the other hand, it could also provide a baseline for society to judge whether the regulatory authorities and regulators have fulfilled their responsibilities correctly and thereby also help prevent regulators from being mistakenly punished. This study proposes that a systematic and functional norm for drug safety and inspection could be set up relating to the determination of the responsibilities of regulatory authorities and scope of various inspections, number and frequency of inspections, number and qualifications of regulators, handling of inspection results, inspection records, and disciplinary codes for inspectors. This study also puts forward suggestions on who should be responsible for drafting the norms and what are the factors that need to be considered while formulating the norms.
authors.affiliation: China Pharmaceutical University, No. 24 Tong Jia Xiang, Gulou District, Nanjing, 210009, China.
authors.forename: Qingsheng
authors.initials: Q
authors.lastname: Xuan
authors.affiliation: Zhejiang University of Technology, No. 18 Chaowang Road, Xiacheng District, Hangzhou, China.
authors.forename: Zuojun
authors.initials: Z
authors.lastname: Dong
authors.affiliation: China Pharmaceutical University, No. 24 Tong Jia Xiang, Gulou District, Nanjing, 210009, China. qingshengmingli@yeah.net.
authors.forename: Mingli
authors.initials: M
authors.lastname: Shao
mesh_terms: D002681:China; D017408:Guidelines as Topic; D004364:Pharmaceutical Preparations / Q000592:standards; D010593:Pharmaceutical Services / Q000458:organization & administration / Q000592:standards; D010605:Pharmacy Administration / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards*; D011678:Punishment
chemical_list: D004364:Pharmaceutical Preparations
keywords: Administrative sufficiency; Drug safety; Inspection norm