ABSTRACT
Narcotic drugs and class Ⅰ psychotropic substances have always been special management drugs in medical institutions. Although relevant policies and regulations have been introduced at the national level ，there are problems of poor policy understanding and inconsistent implementation in medical institutions in the process of policy implementation. In order to standardize the management of narcotic drugs and class Ⅰ psychotropic substances in medical institutions of Yunnan province ， based on the preliminary research and Delphi expert consultation ，this editing group finally formed the Expert Consensus on Key Links Quality Control Management of Narcotic Drugs and Class I Psychotropic Substances in Medical Institutions of Yunnan Province by focusing on the key aspects of quality control of key links for narcotic drugs and class Ⅰ psychotropic substances in medical institutions ，aiming to provide reference for the clinical use and management of narcotic drugs and class Ⅰ psychotropic substances in medical institutions of Yunnan province.
ABSTRACT
OBJECTIVE：To provide sugge stions for improving the variety of pediatric drugs and ensuring the safety of pediatric drug use in China. METHODS ：The historical evolution of laws and regulations on the marketing approval of pediatric drugs in the United States and the implementation results of relevant policies were summarized. Combined with the current situation of the development of pediatric drugs in China ，some suggestions were put forward to ensure the accessibility and safety of pediatric drug use in China. RESULTS & CONCLUSIONS ：Since 1994，the United States had issued a series of laws and regulations to encourage the development of pediatric drugs. At present ，the marketing approval of pediatric drugs were mainly based on the two laws of Best Pediatric Drug Act（BPCA）and Pediatric Research Equality Act （PREA）. From 1998 to 2019，the amount of supplements of pediatric drug information in drug instructions of the United States showed a fluctuating growth. As of April 2020，854 kinds of drugs had been modified in pediatric instructions ，792 of which had been carried out post marketing pediatric clinical research ，and the problem of incomplete pediatric instructions had also been greatly improved. At present ，China’s policies on pediatric drugs mainly included encouraging R&D innovation ，giving priority to review and approval ，and strengthening R&D technical guidance. Although certain achievements had been made ，there were still some problems ，such as imperfect policies and regulations ，and great difficulties carrying out pediatric drug clinical trials. It is suggested that our country should draw lessons from the American regulations on pediatric drugs ，pediatric research and the catalogue of pediatric drugs ，and establish a system and catalogue of ped iatric drug use suitable for China ’s national conditions ，so as to improve the effectiveness ，safety and accessibilityof pediatric drugs.