Ruyi He Biography

Dr. Ru-Yi He received his medical degree from China Medical University. He completed his intern and residency training in Internal Medicine at Howard University Hospital in Washington, DC. He received his clinical and research training at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institutes of Health (NIH) of Bethesda, Maryland. He has published more than 20 research papers and abstracts in the field of Internal Medicine and Drug Regulatory Science. He is a licensed, board-certified physician in Internal Medicine.

Dr. Ru-Yi He joined the Center for Drug Evaluation and Research (CDER), US FDA in 1999 as a Medical Officer in the Division of Gastrointestinal and Coagulation Drug Products. He became a Medical Team Leader in 2003 and served as the Acting Deputy Director for 2 years. He was detailed to the Office of Medical Policy in 2010 and the Office of Generic Products in CDER/FDA in 2015. He chaired several working groups tasked with drafting and finalizing guidances for industry including FDA guidance development in multiple therapeutic areas. He was responsible for approving numerous applications for investigational new drugs (INDs) and new drug applications (NDAs) including applications for Chinese herbal medicines. Dr. Ru-Yi He has received many awards since he joined the FDA, including the FDA Excellence in Review Science Award, CDER Leadership Excellence Award, CDER excellence in mentoring Award, FDA Award of Merit, and the Department of Health and Human Services Secretary’s Award for Distinguished Service.

Dr. He Ru-Yi actively participated in organizing activities to promote Sino-US friendship and cultural exchange. He was elected as Overseas Director at the 5th Council of the China Overseas Exchange Association of the State Council and as Overseas Member at the 9th Committee of China Federation of Returned Overseas Chinese. He was Invited Overseas Representative as well as Convener of Overseas Delegation at the 12th CPPCC National Committee meetings. Dr. He Ru-Yi served as Distinguished Professor of Peking University since 2006.

Dr. Ru-Yi He is the Chief Scientist at the Center for Drug Evaluation at the Chinese Food and Drug Administration (CFDA). Dr. He joined CFDA in July 2016, after having worked at the US Food and Drug Administration (FDA) for more than 17 years.