Regulatory framework of genome-edited products - a review / 生物工程学报

Genome editing is a genetic engineering technique that uses site-directed cleavage activity of specific artificial nucleases and endogenous DNA damage repair activity to generate insertions, deletions or substitutions in the targeted genomic loci. As the accuracy and efficiency of genome editing is improving and the operation is simple, the application of genome editing is expanding. This article provides an overview of the three major genome editing technologies and genome editing types, and the regulatory frameworks for genome-edited products were summarized in the United States, the European Union, and other countries. At the same time, based on the Chinese safety management principles and systems for genetically modified organisms (GMOs), the authors proposed a regulatory framework for genome-edited products. Genome-edited products should first be classified according to whether containing exogenous genetic components such as Cas9 editing enzymes or not. They should be regulated as traditional genetically modified organisms if they do. Otherwise, the regulation of genome-edited products depends on targeted modifications.

Current Challenges of Medical Safety Supervision in China and Suggestions of Improvement: Based on Health Care Quality Supervision Committee's Experience / 中国医院管理

Medical security is a prominent problem in China,and the medical safety supervision system needs to be improved.Through the analysis of the existing literature,medical supervision process,current situation and problems are analyzed,and the medical supervision system in England is comparatively analyzed,and the relationship model of British regulators is built,the internal mechanism of British medical supervision is analyzed,and finally through combining with the actual situation of China,new ideas for perfecting the medical safety supervision are put forward.

US FDA's new measures for strengthening drug safety administration / 中国药学杂志

OBJECTIVE: US FDA's drug safety regulatory new initiatives was interpreted and analyzed to provide lessons for China's drug administration. METHODS: By interpreting US FDA's relevant guidelines on drug safety administration, the measures on strengthening the safety administration, risk assessment and post-market surveillance were introduced and discussed. RESULTS: Lessons was learned by analyzing the successful experiences of FDA drug safety administration and risk management. CONCLUSION: China's drug administration need to take steps to keep focus narrow, attach importance to administrative methodology and innovate policies based on the lessons from US FDA and China's current drug regulatory conditions.