October 31, 2019 – SAN DIEGO, California
The Fourth National Postdoctoral Forum on Drug Safety and Supervision (2019) was held in Beijing on October 25, 2019. The Forum was co-sponsored by the Department of Human Resource of the National Medical Products Administration (NMPA), the Office of China Postdoctoral Council, and China Postdoctoral Science Foundation; and co-organized by NMPA Institute of Executive Development, National Institutes for Food and Drug Control (NIFDC), and Tsinghua University School of Pharmaceutical Sciences. NMPA Deputy Commissioner, Ms. Jiangying Yan, delivered the opening address at the award ceremony. Ms. Yan emphasized that China government has always regarded drug safety and public health as top priority. The National People’s Congress recently approved “The Vaccine Administration Law” and the amendment of “The Drug Administration Law”. NMPA has launched the China Drug Regulatory Science Action Plan to strengthen the science-driven regulatory review and drug administration. She further encouraged young scholars to conduct in-depth research on the implementation of newly released regulatory laws, to investigate the root causes of drug safety issues from multiple perspectives, to provide visional advice to guide future regulatory policies, and to promote communication and experience-sharing with global regulatory experts.
In the Plenary Session, the Deputy Director of the Department of Drug Registration at NMPA, Mr. Maozhong Li, first reviewed the agency history and regulatory legislative reforms that occurred in China over the past two decades; the Director of the Office of Tissue and Advanced Therapies (OTAT) from the Center for Biologics Evaluation and Research (CBER) at US FDA, Dr. Wilson W. Bryan, then gave a presentation on Gene Therapy for Rare Disease; and Director of Information Center at NMPA, Mr. Guo Huang, and Chair of the Department of Regulatory and Clinical Sciences at University of Southern California, Prof. Frances Richmond, also gave keynote speeches. Following the main session, three parallel sessions focused on “Regulation and Legislation”, “Regulatory Science”, and “Smart Regulation.” More than 400 regulatory professionals, including regulatory experts from NMPA Center of Drug Evaluation (CDE), Center of Food and Drug Inspection (CFDI) and NIFDC, attended the Forum.
Following the Forum, a Round Table Discussion, co-organized by Tsinghua University School of Medicine and School of Pharmaceutical Sciences, was held in Tsinghua University on Oct 26. Global regulatory experts including the regulatory reviewers from China NMPA, CDE, CFDI, NIFDC, Dr. Wilson W. Bryan from US FDA CBER OTAT, Dr. Yong Fan from the International Society of Cell and Gene Therapy (ISCT), Dr. Cindy Ru from CRC Oncology and others had an interactive and informative discussion on practical points to consider and evaluate during the Advanced Therapy Regulatory Review.
Tsinghua University alumni, Dr. Qinhua Cindy Ru, the Managing Director of CRC Oncology, reflected on the Forum and the following Round Table Discussion, “We are honored to support the Forum and Tsinghua University, to organize the Panel Discussion on Regulatory Guidelines for Clinical Development and Quality Control in Advanced Therapy, and introduce the top industrial players such as Miltenyi Biotech, CBMG and Cure Genetics to the audience. We are also grateful for the opportunity to connect more global regulatory experts such as Dr. Wilson W. Bryan and Dr. Yong Fan with China regulatory experts. Through attending the Forum and the Round Table Discussion, I am deeply impressed by the regulatory progress that has occurred globally, inside and outside China. I am also thrilled to observe that global regulatory agencies like China NMPA and US FDA are on the same page now when facing the regulatory challenges in Advanced Therapy. A science-driven approach, patient-focused decision-making, and fulfilling unmet medical needs are the core principles for regulatory review and decision making for both agencies.
The Round Table Discussion was interactive, intensive and informative. As Dr. Bryan pointed out, for a fast-growing area like Advanced Therapy, many diverse approaches are involved in regulatory review and evaluation; there is no one perfect approach, and we must share our experience and learn from each other. Following this year’s event, we should look for opportunities to connect more global regulatory experts from US FDA, EU EMA, Japan PMDA and other regional regulatory agencies with China regulatory experts in the future and further promote communication and interactions among the global regulatory agencies. Also, as Dr. Lane Christensen, the Assistant Country Director of US FDA China Office, suggested at the end of the Round Table Discussion, for future events, interactions with more insights from China NMPA will be greatly appreciated. The more we know each other, the better we promote Advanced Therapy globally across different regions.”
About the Fourth National Postdoctoral Forum on Drug Safety and Regulation (第四届全国药品安全与监管博士后论坛)
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About CRC Oncology
CRC Oncology is a contract research organization (CRO) focused on reshaping the global landscape of innovative drugs and therapies for cancer treatment, especially in the field of advanced cell and gene therapy. CRC Oncology provides high quality development and research services by strategically driving global regulatory submissions, authoring quality eCTD dossiers, leading US clinical development at prestigious clinical centers, advancing quality management expertise, building and maintaining a 24/7 audit trail, providing full GxP compliance master quality management systems, and bridging global business development needs. For more information, visit www.crconc.com.