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Regulatory News
CNDA Announces Rules for Abbreviated Registration of Classical an... 6/1/2018
CNDA Publishes Announcement of Generic Drugs Eligible for Exempti... 5/31/2018
CNDA Introduces Two New Technical Guidelines for Antibiotic Drugs... 5/31/2018
Gilead's Pan-Genotypic HCV Treatment Epclusa (Sofosbuvir/Velpatas... 5/30/2018
CNDA and NHC issue Joint Announcement for Optimization of Drug Ev... 5/23/2018
CFDA Releases Generic Drug Quality and Efficacy Equivalence Evalu... 5/22/2018
CNDA Issues New Reg for Confidentiality Management of Drug Evalua... 5/17/2018
CDE Solicits Applicant Feedbacks on Implementation of ICH M4 Guid... 5/16/2018
CNDA to Strengthen Onsite Inspections for Applications of Chemica... 5/14/2018
CNDA Suspends Import of Sun Pharma's Injectable Drug 5/14/2018
CDE Seeks Comments on Draft ICH Guideline for Q12 Lifecycle Manag... 5/11/2018
CNDA Official: More Measures to Raise Review and Approval Efficie... 5/4/2018
CMBA Publishes Quality Control Standard of CAR-T for Public Comme... 5/2/2018
CNDA Grants Conditional Approval of MSD's HPV Vaccine Gardasil 9 4/30/2018
CFDA Releases List of Reference Formulations for Generic Drug Equ... 4/30/2018
CDE Issues Rules and Standards for Fast Reporting of Safety Data ... 4/27/2018
CDE Seeks Comments on New Rule for BE Study Samples of Chemical G... 4/27/2018
CNDA Solicits Comments on Draft Implementation Rules for Drug Tes... 4/26/2018
CNDA Announces Relevant Matters on Custom Clearance of Import Che... 4/26/2018
CNDA Issues New Technical Guidelines for Compatibility Study of C... 4/26/2018
CNDA Issues Announcement over Matters Related to Import of APIs a... 4/24/2018
CDE Publicizes Batch 28 of Drug Applications To Be Granted Priori... 4/23/2018
China-Denmark Drug Regulatory Thematic Seminar held in Beijing (free) 4/23/2018
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