Michael has more than 11 years of regulatory affairs experience in pharmaceutical industry. He has proven record of successful import and local pharmaceuticals registration and Comprehensive knowledge of NMPA(NMPA)/CDE requirements, policies and processes CTA, IMCT, NDA, Variation, Renewal, QC testing, CDE consulting meetings. Through the years, Michael filed over 30 CTA and IMCT, 6 NDA, 80 renewal and arranged over 20 CDE/NMPA meetings.