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The evolving regulatory system of advanced therapy medicinal products in China: a documentary analysis using the World Health Organization Global Benchmarking Tool standards
Shi, Junnan1; Chen, Xianwen1; Hu, Hao1,2,3; Ung, Carolina Oi Lam1,2,3
2024-08
Source PublicationCytotherapy
ISSN1465-3249
Volume26Issue:8Pages:954-966
Abstract

Advanced therapy medicinal products (ATMPs) are rapidly evolving to offer new treatment options. The scientific, technical, and clinical complexities subject drug regulatory authorizes to regulatory challenges. To advance the regulatory capacity for ATMPs, the National Medical Products Administration in China made changes to the drug regulatory system and developed regulatory science with the goal of addressing patient needs and encouraging innovation. This study aimed to systematically identify the regulatory evidence on ATMPs in China under the guidance of an overarching framework from the World Health Organization Global Benchmarking Tool. It was found that China's administrative authorities at all levels have issued a number of policy documents to promote the development of ATMPs, covering biopharmaceutical products research and development (n = 14), biopharmaceutical industry development (n = 9), high-quality development of medical institutions (n = 1), specific development plans/projects (n = 6) and specific regional development (n = 4). The legal and regulatory framework of ATMPs in China has been established and is subject to continuous adjustment in various aspects including regulations (n = 3), departmental rules or administrative normative documents (n = 22), and technical guidance (n = 15). As the regulatory reform continues, the drug review processes have been revised, and various technical standards have been launched, which aim to establish a regulatory approach that oversees the full life-cycle development of ATMPs in the country. The limited number of investigational new drug applications and approved ATMPs suggests a lag remains between the translation of advanced therapeutic technologies into clinically available medical products. To accelerate the translational research of ATMP in countries such as China, developing and adopting real-world evidence generated from clinical use in designated healthcare facilities to support scientific decision-making in ATMP regulation is warranted. The enhancement of regulatory capacity building and multi-stakeholder collaborations should also be encouraged to facilitate the timely evaluation of promising ATMPs to meet more patient needs.

KeywordAdvanced Therapy Medicinal Products China Drug Regulatory Authority Global Benchmarking Tool (Gbt) Regulatory Science
DOI10.1016/j.jcyt.2024.04.070
URLView the original
Indexed BySCIE
Language英語English
WOS Research AreaCell Biology ; Biotechnology & Applied Microbiology ; Hematology ; Research & Experimental Medicine
WOS SubjectCell & Tissue Engineering ; Biotechnology & Applied Microbiology ; Cell Biology ; Hematology ; Medicine, Research & Experimental
WOS IDWOS:001277108300001
PublisherELSEVIER SCI LTD, 125 London Wall, London EC2Y 5AS, ENGLAND
Scopus ID2-s2.0-85192708341
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Document TypeJournal article
CollectionFaculty of Health Sciences
Institute of Chinese Medical Sciences
THE STATE KEY LABORATORY OF QUALITY RESEARCH IN CHINESE MEDICINE (UNIVERSITY OF MACAU)
DEPARTMENT OF PUBLIC HEALTH AND MEDICINAL ADMINISTRATION
Corresponding AuthorUng, Carolina Oi Lam
Affiliation1.State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Taipa, Macao
2.Centre for Pharmaceutical Regulatory Sciences, University of Macau, Taipa, Macao
3.Department of Public Health and Medicinal Administration, Faculty of Health Sciences, University of Macau, Taipa, Macao
First Author AffilicationInstitute of Chinese Medical Sciences
Corresponding Author AffilicationInstitute of Chinese Medical Sciences;  University of Macau;  Faculty of Health Sciences
Recommended Citation
GB/T 7714
Shi, Junnan,Chen, Xianwen,Hu, Hao,et al. The evolving regulatory system of advanced therapy medicinal products in China: a documentary analysis using the World Health Organization Global Benchmarking Tool standards[J]. Cytotherapy, 2024, 26(8), 954-966.
APA Shi, Junnan., Chen, Xianwen., Hu, Hao., & Ung, Carolina Oi Lam (2024). The evolving regulatory system of advanced therapy medicinal products in China: a documentary analysis using the World Health Organization Global Benchmarking Tool standards. Cytotherapy, 26(8), 954-966.
MLA Shi, Junnan,et al."The evolving regulatory system of advanced therapy medicinal products in China: a documentary analysis using the World Health Organization Global Benchmarking Tool standards".Cytotherapy 26.8(2024):954-966.
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