Weigh! CDE issues new rules on dispute resolution procedure of drug registration review conclusion

Original: dishishsinan On November 26, 2019, the official website of the drug review center (CDE) of the State Drug Administration (SDA) released the notice on Soliciting Opinions on the dispute resolution procedure for the conclusion of drug registration review publicly, which showed us once again the determination and action of the SDA to improve the dispute resolution mechanism for the conclusion of drug registration review in China This paper combed the relevant issues of the dispute resolution mechanism for drug review Knowledge points The food and Drug Administration of the United States (FDA) is one of the earliest countries in the world to implement dispute resolution mechanism in drug review conclusion, and carry out drug registration review scientifically and efficiently After more than ten years of development, the dispute resolution procedure of drug review conclusion in the United States has gradually improved and refined its regulatory system At present, the dispute resolution mechanism of the conclusion of drug registration review in China is not perfect, and there are many problems in the dispute resolution mechanism, which mainly focuses on review Therefore, the drug review center of the State Drug Administration, on the one hand, draws lessons from the experience of FDA in the United States, and on the other hand, plans to establish a set of dispute resolution mechanism of drug review in line with the actual situation in China.