报告题目： US Generic Product Development, Registration and Approval
主 讲 人：郭晓迪 博士 CSO and Executive VP of Huahai US Inc.
主 持 人：吴传斌 教授 中山大学药学院副院长
Dr. Xiaodi Guo is the Chief Scientific Officer/Executive VP of Huahai US Inc. located in NJ. Dr. Guo established the Chinese pharmaceutical industry’s first R&D center in USA and obtained the first-ever ANDA approval from a Chinese pharmaceutical company after a successful FDA site inspection in China two years ago. He has 25 years pharmaceutical product development experience and has held various scientific and managerial positions at leading specialty and generic US pharmaceutical companies with growing responsibilities prior to joining Huahai. He was formerly the Manager of Shire Labs, Team Leader of Barr Labs, Director of Banner Pharmacaps, and VP at Abrika Pharmaceuticals (Now Actavis Group) where he established the company's productive R&D team and research/manufacturing facility from ground up. In his career, Dr. Guo was the leading contributor of many advanced drug delivery technologies and developed many NDA/ANDA products currently marketed in US. He has more than 50 publications and is the inventor of more than ten patents. Dr. Guo graduated from The University of Texas at Austin.
China is inevitably becoming a hotspot of global pharmaceutical R&D and manufacturing and its pharmaceutical market will reach top five in the world during the next few years. China has already become the leading manufacture and supply of chemicals and active pharmaceutical ingredients (API) worldwide. However, the finished dosage form manufacturing in China for highly regulated markets remains as one of the weakest sides of global pharmaceutical services and supply chains. Several Chinese pharmaceutical companies had worked on EU and FDA registration and facility approval for many years. Today, Zhejiang Huahai Pharmaceutical Co. is the only Chinese company successfully passed FDA inspection and obtained both API and finished dosage form US FDA approval.
This presentation overviews the generic product development process, FDA registration, and the facility pre-approval inspection. The current trends of pharmaceutical development and manufacturing in China will be discussed and some hand-on experiences will be presented.