The China FDA (CFDA) sent shockwaves through the drug development world in late May 2017 releasing 4 draft guidelines for public comments. In essence, these guidelines will bring China to the forefront of global drug development. The agency is poised to kick start first-in-human clinical trials in a country that is known for conservatism when it comes to medicine. Various measures to enable such a move are being proposed. In addition, the CFDA just applied for ICH membership, further bringing the country to align with international standards.
Something of this magnitude does not happen very often and raises many questions such as: What does this mean for drug developers, domestic and foreign? How can you take advantage of these changes? What should you prepare to ensure your drug is positioned properly? To answer these questions, we present two Chinese drug industry leaders who will provide interpretation of the new regulations AND the implications to drug developers.
Dr. Simon Li has over 20 years of R&D experience in US and China. Dr. Li worked in US for 15 years in several companies including Eli Lilly, Bayer, Pharmacia, and Roche on a variety of clinical capacities. During this time, he led 10 clinical programs and obtained one NDA approval.
Dr. Li then moved to Beijing to help Bayer Health establish a global development center. He successfully led the team to obtain CTA approval via Green Channel for an antibiotic drug and conduct a pivotal trial in China/AP for approval of a skin indication.
Dr. Li is currently CMO of CSPC Pharma Group, a major pharma company in China. In this role, Dr. Li leads the company’s global development efforts.
Dr. Dan Zhang has over 20 years of drug development experience. He was VP and General Manager of Quintiles. After the company went public, Dr. Zhang became Head of Clinical Drug Development at Sigma-Tau USA, a large Italian drug maker.
Dr. Zhang is heavily involved in drug development and regulatory reform in China. He has been a long time CFDA advisor, helping the agency modernize its regulations. He has served on the Agency’s New Drug Review Committee. Dr. Zhang is also responsible for drafting multiple Guideline documents for the CFDA.
Dr. Zhang is currently the Executive Chairman of Fountain Medical Development, a major CRO in China with a global footprint.