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In order to ensure the quality of drug non-clinical evaluation research and ensure the public use of drugs, the State Food and Drug Administration recently issued the newly revised "Non-clinical Drug Research Quality Management Practices" (CFDA Order No. 34) (hereinafter Referred to as "Specification"). The "Code" has 12 chapters and 50 articles, including general rules, terms and definitions, organization and personnel, facilities, equipment and experimental materials, experimental systems, standard operating procedures, implementation of research work, quality assurance, data files, and entrusting parties And by-laws. The "Regulations" will be implemented on September 1, 2017, and the "Non-clinical Drug Research Quality Management Practices" (formerly State Food and Drug Administration Order No. 2) issued on August 6, 2003 will be repealed at the same time.

In view of the weak links and existing problems in the past implementation, the "Specifications" draws on international practices and combines my country's national conditions to further clarify the responsibilities of the relevant personnel of research institutions, stipulating that the head of the institution should ensure the standardization of the overall work of the research institution, and the person in charge of the topic is responsible Approve the test plan and summary report; strengthen the main responsibility of the research client, and set up a special chapter to clarify the client's responsibilities for evaluating research institutions, approving the test plan, and providing true and reliable test materials and reference materials and their quality information.

To adapt to the emergence of new concepts and the application of new technologies in the field of non-clinical drug research, the "Specifications" further enriched the management requirements related to research, including management requirements for multi-site research, management requirements for computerized systems, relevant electronic data and electronics Signature application requirements, etc.; a new chapter on quality assurance was added to ensure the authenticity, standardization and integrity of research data.

The implementation of the "Specifications" will help further improve the level of non-clinical drug research in my country and ensure the quality of drug research.

The Food and Drug Administration issued