CFDA Releases Good Practice for Non-clinical Research of Drugs

In order to ensure the quality of non-clinical evaluation research of drugs and protect public use, the State Food and Drug Administration recently issued the newly revised "Good Management Practice for Non-clinical Research of Drugs" (Order No. 34 of the State Food and Drug Administration) (hereinafter referred to as the "Specification"). 

The Code consists of 12 chapters and 50 articles, including general principles, terms and definitions, organizational structure and personnel, facilities, instruments and experimental materials, experimental systems, standard operating procedures, implementation of research work, quality assurance, data files, commissioning parties and supplementary provisions. 

The Code will come into force on September 1, 2017, and the Good Practice for Non-clinical Research of Drugs (formerly Order No. 2 of the State Food and Drug Administration) issued on August 6, 2003 will be abolished at the same time. In view of the weak links and existing problems in the past implementation, the Code draws on common international practices and combines China's national conditions to further clarify the responsibilities of relevant personnel of research institutions, stipulating that the head of the institution shall ensure the standardization of the overall work of the research institution, and the person in charge of the topic shall be responsible for approving the test plan and summary report; Strengthen the main responsibility of the research client, and set up a special chapter to clarify the responsibilities of the commissioning party to evaluate the research institution, approve the test plan, and provide true and reliable test subjects and reference substances and their quality information. 

Adapted to the emergence of new concepts and the application of new technologies in the field of non-clinical research of drugs, the Code further enriches the management requirements related to research, including the management requirements of multi-site research, the management requirements of computerized systems, and the application requirements of electronic data and electronic signatures. 

A new chapter on quality assurance has been added to ensure the authenticity, standardization and completeness of research data. The implementation of the Code will help further improve the level of non-clinical drug research in China and ensure the quality of drug research.



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