In order to ensure the quality of non-clinical evaluation of drugs and to protect the public, recently, the State Food and Drug Administration issued a new revised Code of Quality Management for Non-Clinical Research of Drugs (Order No. 34 of the State Food and Drug Administration) (below) Referred to as "the norm"). The Code contains 12 chapters and 50 articles, including general rules, terminology and definitions, organization and personnel, facilities, equipment and experimental materials, experimental systems, standard operating procedures, implementation of research work, quality assurance, data files, and clients. And supplementary rules. The "Specifications" will be implemented on September 1, 2017, and the "Non-Clinical Research Quality Management Regulations" (formerly the State Food and Drug Administration Order No. 2) issued on August 6, 2003 shall be abolished at the same time.

 

In order to address the weak links and existing problems in the past, the Code draws on international practices and combines China's national conditions to further clarify the responsibilities of relevant personnel of the research institute. It is stipulated that the responsible person of the organization should ensure the standardization of the overall work of the research institution. Approve the test plan and summary report; strengthen the main responsibility of the research client, set up a special chapter to clarify the responsibilities of the client to evaluate the research institution, approve the test plan, and provide real and reliable test objects and reference materials and their quality information.

 

Adapting to the emergence of new concepts in the field of non-clinical research in medicines and the application of new technologies, the Code further enriches research-related management requirements, including management requirements for multi-site research, management requirements for computerized systems, and related electronic data and electronics. Signature application requirements, etc.; a new quality assurance chapter to ensure the authenticity, standardization and integrity of the research data.

 

The implementation of the "Code" will help to further improve the level of non-clinical research on drugs in China and ensure the quality of drug research.