Part 2: Focal points in Drug Submission to NMPA

This Part II of our China NMPA Regulatory webinar series will give detailed information about drug registration requirements and the regulatory pathway for pharmaceuticals in China. The NMPA approval process has gone through optimization over recent years, with improved panel review systems, centralized dossier system, and more efficient communication channels. Ensuring clear and organized application and effective communication with the regulatory reviewers can be fool proof, as long as you understand the dynamics within this seemingly complex regulatory framework.

FEATURED SPEAKER 

Yuan Ma, Ph.D. 

Senior Regulatory Affairs Director

SAFE Pharmaceutical Group

Beijing, China

Dr. Yuan Ma is a drug and medical device researcher with two decades of experience in drug discovery and preclinical and clinical studies.

Dr. Ma specializes in regulatory affairs for drug and medical device registration for China submission. Dr. Ma has consulted in clinical studies and drug pharmacovigilance with the Yangtze River Pharmaceutical Group, and Beijing Haiyan Pharmaceutical. He has also consulted extensively with the VenturePharm Clinical Research Center in medical affairs.

In academia, Dr. Ma was Director and Associate Professor at Wangjing Hospital, China Academy of Traditional Medical Sciences, Department of Pharmacology and Clinical Research. He also tenured as Associate Professor at the Institute of Pharmacology & Toxicology, Academy of Military and Medical Sciences.

Dr. Ma earned his Ph.D. from the Institute of Pharmacology & Toxicology, Academy of Military and Medical Sciences; and his Master of Sciences from Inner Mongolia Medical College in China.

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UPCOMING WEBINARS 2021 DEC: China NMPA Regulatory Approval Process: Part 3 – Emerging Markets and Innovation