Andrew Chen has over 20 years of experience in food and drug law, including serving in the U.S. Food and Drug Administration (2000-2004) in Rockville, Maryland as Assistant Chief Counsel, and Amgen (2006-2010) in Thousand Oaks, CA as Senior Counsel. Andrew was born and grew up in China, graduated from Peking University, and is admitted to practice in Washington, D.C.
Leveraging this very unique experience, Andrew has been effectively assisting life sciences companies doing business in China and the U.S. to resolve the most challenging legal and regulatory issues, set out critical strategies and implementation plans, respond to ever-increasing government oversight, mitigate enforcement risks, and successfully conduct product licensing and collaboration, clinical trial, product registration, manufacturing, sales and marketing, pharmacovigilance, and pricing and reimbursement.
Andrew has also been actively assisting, on a pro bono basis, the China National Medical Products Administration (NMPA, formerly known as CFDA and SFDA) and various academic organizations to better understand the U.S. FDA framework, and help the NMPA to further reform and align with the leading international regulatory systems.
- 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.
- J.D., University of Nebraska College of Law,
- LL.B., Peking University
- District of Columbia
- Executive Editor, Nebraska Law Review
- Chinese (Mandarin)