Research on the Optimization of the Registration Classification of Biological Products in China

Abstract

Objective To provide a theoretical basis for the adjustment of the registration classification of China’s biological products, and to establish a continuously improved registration classification system. Methods Based on literature research, the specific classification methods, classification principles and considerations of biological registration in China, the United States and the European Union were studied to form a complete comparative analysis. Results and Conclusion It is recommended that the division between therapeutic and preventive use should beremoved from the registration classification of biologics. The therapeutic, preventive and diagnostic use of the product should be limited as part of the product specification, and the registration should be classified according to the development of biotechnology, innovation, modification and bio-similar drugs. In addition, the supervision of registration of advanced therapeutic products should be different from that of traditional biologics.

Keywords

biological product / registration classification / classification principle / consideration factor

References

[1] NMPA. Classification of Biological Products for Registration and Reporting Information Requirements[EB/OL]. (2020-06-30)[2023-01-03]. https://www.nmpa.gov.cn/zhuanti/ypzhcglbf/ypzhcglbfzhcwj/20200630175301552.html.

[2] Public Health Services Act. PHSA[EB/OL]. (1944-07-08)[2023-01-04]. https://legcounsel.house.gov/Comps/PHSA-merged.pdf.

[3] FDA. Definition of the Term “Biological Product” (Proposed Rule) Preliminary Regulatory Impact Analysis[EB/OL]. [2023-01-04]. https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber.

[4] FDA. Biosimilar and Interchangeable products[EB/OL].(2017-10-20)[2023-01-05]. https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products.

[5] Guo Qixiang, Yang Jingshu, Yang Yue. Preliminary study on China’s innovative on biological product registration classification[J]. Chinese Journal of New Drugs, 2022, 31 (24): 2444-2451.

[6] FDA. Intercenter Agreements between the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research[EB/OL]. (2017-10-23)[2023-01-05]. https://www.fda.gov/combination-products/classification-and-jurisdictional-information/transfer-therapeutic-biological-products-center-drug-evaluation-and-research.

[7] Office of the Commissioner. Transfer of therapeutic biological products to the Center for Drug Evaluation and Research[EB/OL]. [2023-01-06]. https://www.fda.gov/combination-products/jurisdictionalinformation/transfer-therapeutic-biological products-center-drug-evaluation-and-research.

[8] FDA. Tissue & Tissue Products[EB/OL]. (2022-12-09)[2023-01-06]. https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products.

[9] EMA. European Medicines Agency Procedural Advice for Users of the Centralized Procedure for Similar Biological Medicinal Products Applications[EB/OL]. (2020-08-26)[2023-01-06]. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-procedural-advice-users-centralised-procedure-similar-biological-medicinal-en-0.pdf.

[10] Zhou Qingping, Huang Xiaocui, Hu Xinya, et al. Analysis of the development status of advanced therapeutic drugs in Europe and America[J]. Central South Pharmacy, 2021, 19 (10): 2095-2104.

[11] Iglesias-López C, Agustí A, Obach M, et al. Regulatory framework for advanced therapy medicinal products in Europe and United States[J]. Front Pharmacol, 2019, 10: 921.

[12] European Medicines Agency. Reflection Paper on Classification of Advanced Therapy Medicinal Products[EB/OL]. (2015-06-08)[2023-01-08]. https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-classification-advanced-therapy-medicinal-products_en-0.pdf.

[13] Kurz X. Advancing regulatory science, advancing regulatory practice[J]. Pharmacoepidemiology & Drug Safety, 2017, 26 (6): 722-726.