title: Regulatory science accelerates the development of biotechnology drugs and vaccines by NIFDC.
abstract: The Chinese National Institutes for Food and Drug Control (NIFDC) is the national laboratory responsible for the quality control of pharmaceutical products. In recent years, to ensure the quality of biological products and improve the research and development (R&D) of new biological drugs and vaccines, NIFDC conducted a series of regulatory science studies on key technologies for quality control and evaluation, and established a quality control and evaluation platform for biological drugs and vaccines. These studies accelerated the R&D of the biological drugs and vaccines in China and assured their safety and efficacy. In this paper, NIFDC's duties and achievements in the biological drug and vaccine field are summarized.
authors.affiliation: National Institutes for Food and Drug Control, Beijing 100050, China.
authors.forename: Zhenglun
authors.initials: Z
authors.lastname: Liang
authors.affiliation: National Institutes for Food and Drug Control, Beijing 100050, China.
authors.forename: Qunying
authors.initials: Q
authors.lastname: Mao
authors.affiliation: National Institutes for Food and Drug Control, Beijing 100050, China.
authors.forename: Yiping
authors.initials: Y
authors.lastname: Wang
authors.affiliation: National Institutes for Food and Drug Control, Beijing 100050, China.
authors.forename: Changgui
authors.initials: C
authors.lastname: Li
authors.affiliation: National Institutes for Food and Drug Control, Beijing 100050, China.
authors.forename: Kai
authors.initials: K
authors.lastname: Gao
authors.affiliation: National Institutes for Food and Drug Control, Beijing 100050, China.
authors.forename: Junzhi
authors.initials: J
authors.lastname: Wang
keywords: biotechnology drug; quality control; vaccine