To further strengthen the exchange and experience sharing on Chinese and foreign drug regulatory policies and regulations, as well as the latest pharmaceutical technologies related to biologics, the 4th China Biologics CMC Conference, hosted by the China Center for Food and Drug International Exchange under the guidance of the Center for Drug Evaluation of the National Medical Products Administration (NMPA), was successfully held in Tianjin from Dec 26 to 27, 2024. The conference tracks the latest global trends in biologics technology and regulation and enhances communication between regulatory agencies and the industry. Cao Xuetao, Vice-minister of the National Health Commission, Xie Yuan, Vice-mayor of Tianjin, and Huang Guo, deputy Commissioner of the NMPA, attended the conference and delivered speeches.

　　The conference proposed the commitment to fully implement the decisions and plans set by the Third Plenary Session of the 20th CPC Central Committee on “improving the mechanism for supporting the development of innovative drugs and medical devices” and to develop the biopharmaceutical industry, which is a strategic emerging industry crucial to the national economy, people's livelihoods, and national security. We must resolutely adhere to the people-centered and clinical-needs-driven principles, continue to deepen the reform on review and approval system, strengthen legal foundation, promote international cooperation, improve the regulatory system, and accelerate the innovative technologies transformation and products launching. These efforts will contribute to the developing strategy of building a Healthy China and continuously improving public health.

　　Cao Lili, deputy Director-general of the China Center for Food and Drug International Exchange, hosted the opening ceremony of the conference. Zhou Siyuan, Director-general of the Center for Drug Evaluation of the NMPA, was presented at the opening ceremony. Wang Junzhi, academician of the Chinese Academy of Engineering, Xie Xiaoliang, academician of the Chinese Academy of Sciences, Liu Depei, academician of the Chinese Academy of Engineering, Wang Tao, deputy Director-general of the Center for Drug Evaluation of the NMPA, Peter Marks, Director of the Center for Biologics, Evaluation and Research (CBER) of the FDA, and He Wu, Director of the Office of Pharmaceutical Science of Biological Products at the Center for Drug Evaluation of the NMPA, delivered keynote speeches on “Key Research Directions for Vaccine Development and Regulation in China”, “Updates in Genomic Medicine”, “Quality Control of CGT Products”, “Development and Perspectives of Biotechnology Products”, “Promise of Advanced Therapeutic Medicinal Products”, and “Updates and Perspectives of Biologics CMC Technical Review in China”, respectively.

　　The conference consists of six major modules, namely “Innovation Research and Risk Control of Advanced Therapy Medicinal Products”, “Research and Risk Control of Changes in Cell Therapy Products”, “Research Updates and Technical Requirements of Viral Vectors”, “Progress and Technical Requirements in the Development of Innovative Antibodies”, “Technical Review of Vaccine Products”, and “Technical Review of Blood Products”. Representatives from domestic and foreign regulatory authorities for biologics shared new progress in regulations and technical guidelines. Experts and scholars from relevant academic associations and industry shared their new technologies and insights in the fields of pharmaceuticals, clinical trials, pharmacology, and toxicology of biologics from different perspectives. Nearly 750 academicians, well-known experts and scholars, representatives of domestic and foreign drug regulatory authorities, associations, and pharmaceutical companies participated in the conference.

　　The 4th China Biologics CMC Conference has been held for four consecutive years and has developed into a landmark exchange platform in the field of biologics regulation in China. The conference is committed to achieving effective communication between regulatory authorities and the industry in the field of biologics quality control, assisting biopharmaceutical companies in R&D and GMP of biologics, and playing an important role in supporting the high quality development of the biopharmaceutical industry.