Andrew Shaoyu Chen is a partner in the firm's Life Sciences and Healthcare Regulatory Group, bringing nearly 20 years of experience in food and drug law, including serving in the US Food and Drug Administration (2000-2004) as Assistant Chief Counsel, and Amgen (2006-2010) as Senior Counsel. Leveraging this very unique experience, Mr. Chen has been effectively assisting life sciences companies doing business in China, ranging from Fortune 500 to midsize and small startups, to resolve their most challenging legal and regulatory issues.
Prior to joining the firm, Mr. Chen was a partner at another Am Law 100 firm (2011-2018), leading their China food and drug practice group from the Beijing and Shanghai offices. Mr. Chen was born and grew up in China, has lived in the US for two decades, and returned to China for nearly 10 years. As such, Mr. Chen is able to bring extra value and practical solutions to clients, based on his deep understanding of the legal, cultural, and business practices in the East and the West.
- Identify the most efficient regulatory pathways and implementation strategies for the China market.
- Counsel on the pros and cons of importation versus local manufacturing, focusing on technology transfer, licensing, and co-development issues.
- Advise on product development in China, including regulatory submissions and oversight ethics committee review, clinical trial agreements, investigator meetings, informed consent, and subject injury compensation.
- Assist in obtaining product registration and manufacturing authorizations, including seeking expedited review and facilitating regulatory negotiations.
- Advise on data protection and marketing exclusivities in China, particularly those related to China's new drug monitoring period, to prevent imported drugs from being excluded from the Chinese market.
- Assist on product launch and commercialization efforts, including advertising and promotion, wholesale and retail distribution, and pricing and reimbursement.
- Assist on internal audits and responding to regulatory agency inspections on GLP, GCP, GMP, and GSP compliance, including pharmacovigilance and product recall.
- Advise on anti-unfair competition issues.
- JD, University of Nebraska College of Law, 2000, with distinction
- LLB, Peking University, 1985
- District of Columbia
- Chinese (Mandarin)