To enhance the management of the Phase I clinical trial of drugs, effectively safeguard the rights, benefits and safety of trial subjects, and improve the research quality and management of the Phase I clinical trial of drugs, the State Food and Drug Administration (SFDA) organized the drafting and recently issued the Guideline on Management of Phase I Clinical Trial of Drugs (interim) in accordance with the Drug Administration Law of the People's Republic of China, the Provisions for Drug Registration and the Good Clinical Practice (GCP).

The Guideline contains 54 articles under 14 chapters, which specifies the responsibilities, conducting requirements, management systems and standard operating procedures, quality assurance, risk management, contracts and agreements, trial protocols, management of subjects, management of investigational products, management and analysis of biological samples, data management and statistical analysis for the management of the Phase I clinical trial of drugs. The Guideline went into effect as of the date of promulgation.

Source:eng.sfda.gov.cn