Organizations must adopt a strategic approach to enter and thrive in the Asian market. This approach requires vigilance on the organization’s part to keep abreast of recent regulatory changes as well as the overall market access environment. In order to have a good system and adequate regulations to guide the biopharmaceutical development process, China State Food and Drug Administration (SFDA) is updating its laws, provisions and guidelines on a regular basis. Major structure changes at SFDA/CDE in 2010 resulted in added complexity in the regulatory environment and drug development processes that manufacturers need to be aware of if they plan to seek product registrations in China.
This webcast provides an overview of China’s regulatory system and SFDA structure; regulations and guidelines; current regulatory environment and trends; registration requirements/process/strategies; and the challenges and opportunities in clinical application and marketing application approvals. The speakers share their personal experiences of developing biopharmaceutical products in China and rely on their years of expertise as they answer participants’ questions.
Learning Level: Intermediate
Upon completion of this webcast, participants should be able to:
- Explain the regulatory requirements/process and current environment for biopharmaceutical registrations in China
- Discuss the detailed strategies in biopharmaceutical development in China
- Outline the detailed process for clinical trial applications and requirements
- Recognize how to take the opportunities and mitigate challenges around clinical applications and marketing application approvals
Who should attend?
- Regulatory professionals who have the responsibility for or interest in developing and registering biopharmaceutical products in China
- Regulatory professionals who manage global, Pan-Asian and Chinese clinical trials
Xin Min Yue is a senior consultant at PAREXEL International, providing biopharmaceutical industry services in regulatory strategies for drug development, clinical trial applications and marketing application submissions/registrations in emerging markets. She has more than 20 years of pharmaceutical research and regulatory experience. Previously, Min worked for Eli Lilly as a biochemist and regulatory manager. During her tenure at the international regulatory affairs group at Lilly, she involved in multiple late stage product development projects, providing global and Pan-Asian clinical trial strategic planning and supported multiple NCE and New Indication registrations for emerging markets. She is a subject matter expert in China regulations, clinical trial permission/import drug license (CTP/IDL) submission process and regulatory responses. Min was a veterinarian in China 1991 and holds an MS in veterinary immunology from the University of Wisconsin-Madison. She is a RAPS member and earned her RAC(US) in November 2006.
Jin Shun is a regulatory director for PAREXEL Asia Pacific and has worked in the regulatory field in the pharmaceutical industry for 16 years. Previously, he worked for SINE pharmaceutical (one of the biggest Chinese local pharmaceutical companies), Nycomed, Johnson & Johnson and GE Healthcare. He has engaged in a variety of regulatory activities including regulatory submissions, regulatory advice and product development strategy in the Asia-Pacific region, especially in China. In his current role, he leads the regulatory affairs team to provide services to the pharmaceutical industry on clinical trial approval (CTA) applications, product registrations and regulatory consultation in the Asia-Pacific region. He also has experience in GMP-related pharmaceutical manufacturing process including variation submission to US and EU health authorities and regulatory activities for OTC and healthcare products. He holds an MBA from BI Norwegian School of Management.