The State Food and Drug Administration has released the "Quality Management Standards for Non Clinical Research of Drugs"

To ensure the quality of non clinical safety evaluation research on drugs and ensure public medication safety, the State Food and Drug Administration recently released the newly revised "Quality Management Standards for Non clinical Research on Drugs" (Order No. 34 of the State Food and Drug Administration) (hereinafter referred to as the "Standards"). The "Specification" consists of 12 chapters and 50 articles, including general provisions, terms and their definitions, organizational structure and personnel, facilities, instruments and equipment, experimental materials, experimental systems, standard operating procedures, implementation of research work, quality assurance, data archives, commissioning parties, and supplementary provisions. The "Standards" will come into effect on September 1, 2017, and the "Quality Management Standards for Non Clinical Research of Drugs" (formerly Order No. 2 of the State Food and Drug Administration) issued on August 6, 2003 will be simultaneously abolished.

The "Norms" address the weak links and existing problems in previous implementation, draw on international practices, and combine with China's national conditions to further clarify the responsibilities of relevant personnel in research institutions. It stipulates that the head of the institution should ensure the standardization of the overall work of the research institution, and the thematic leader is responsible for approving the experimental plan and summary report; Strengthen the main responsibility of the research commissioning party, establish a special chapter to clarify the responsibilities of the commissioning party in evaluating the research institution, approving the experimental plan, and providing true and reliable information on the quality of the test substance and control substance.

In response to the emergence of new concepts and the application of new technologies in the field of non clinical drug research, the "Standards" have further enriched the management requirements related to research, including management requirements for multi site research, management requirements for computerized systems, and application requirements for electronic data and electronic signatures; Add a new chapter on quality assurance to ensure the authenticity, standardization, and completeness of research data.

The implementation of the 'Standards' will help further improve the level of non clinical drug research in China and ensure the quality of drug research.

(Source: Jiangsu Provincial Food and Drug Administration)