Asian Journal Of Social Pharmacy

Objective To summarize the registration of biological products (BPs) included in the priority review and approval procedure (PRAP) from 2016 to 2023 in China, analyze the characteristics of the registration classifications, and to find out the opportunities and challenges brought by the priority review and approval (PRA) system to biopharmaceutical enterprises. Methods Registration applications for the BPs in PRAP published in the “List of Products Included in Priority Review (LPIPR)” of the Center for Drug Evaluation (CDE) of National Medical Products Administration website by June 1st, 2023 (by acceptance number) were collected as raw data. Then, statistical analysis was conducted to investigate the basic information, dosage form, product information, therapeutic areas, regulatory basis of inclusion, and review conclusion of the BPs in PRAP. Results and Conclusion As of June 1st, 2023, a total of 287 BP registration applications (BPRAs) had been included in PRAP, including 238 marketing authorization applications (MAAs), and the number of domestic BPs was basically the same as that of imported BPs. Among the BPs in PRAP, injections were in absolute dominance. The number of recombinant monoclonal antibody drugs ranked first. Tumors, hematologic systemic disorders, and endocrine and metabolic system diseases were of the top three therapeutic areas. Innovation, therapeutic advantages, clinical needs, and pediatric and rare diseases were the most common reasons for inclusion. All clinical trial applications (CTAs) and supplementary applications (SAs) in PRAP were approved. Among the 238 MAAs, 216 applications were reviewed, of which 11 applications failed, with a passing rate of 94.9%. The PRA system has injected new impetus into China’s biopharmaceutical industry, brought development opportunities, and posed new challenges. Biomedical enterprises should seize opportunities, face challenges, and make greater progress through continuous innovation.