Discussion on the method to confirm the testing ability of radiological health technical service institutions / 中国辐射卫生

In this paper, the notice of "Opinions of the State Administration for Market Regulation on further promoting the reform of qualification accreditation of inspection and testing institutions" (No. 206 [2019] which issued on October 25, 2019 has aroused our reflection to concern the development trend of qualification accreditation of radiological health technical service institutions. In order to adapt to the changes under the new situation and avoid the risks of technical review that may be faced in the qualification accreditation of radiation health technical service institutions in the future and to discussed the ways that radiological health technical service institutions can be used to confirm the testing ability in the qualification certification process.

A study of establishment of non-standard methods in qualification accreditation of virological laboratories / 中华实验和临床病毒学杂志

The laboratories of National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, have developed a series of experimental method . These method have unique advantages over the national standard method and industry standard method . How to make these method become public products through legal procedures to serve disease prevention and control more extensively is an obligatory task for national virological laboratories. This article explores the establishment, verification, validation, and examination of virological non-standard method under laboratory certification and accreditation conditions through empirical research on the " RT-RAA method for detecting EV71/CA16 and other viruses" .

Practice and Experience of Application and Report for the Accreditation of Drug Clinical Trial Institution Qualification of Our Hospital / 中国药房

OBJECTIVE:To introduce the experience of application and report for accreditation of drug clinical trial institution qualification of our hospital,to provide a reference for other hospitals. METHODS:From the building of institution,drug clinical trial ethics committee,clinical trials of listed drugs,simulated qualification accreditation,and other aspects,the experience and key points of application and report for accreditation of drug clinical trial qualification of our hospital were summed up. RESULTS& CONCLUSIONS:Priority should be given to staffing(particularly the leaders of the institution),the installation of software and hardware (for system development,training,institution office and specialized department),and the building of ethics committee. Departments should share work experience of clinical trials of listed drugs and set up a self-inspection group to simulate qualifica-tion accreditation. Work procedures and methods of qualification accreditation should be clearly understood,the requirements of Good Clinical Practice,the standards for qualification accreditation,should be known well;Good Clinical Practice should be seri-ously implemented and the subjects’rights and interests should be protected,which will contribute to the successful completion of application and report for qualification accreditation.