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Current landscape of innovative drug development and regulatory support in China

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Tan, Ruirong, Hua, Hua, Zhou, Siyuan, Yang, Zhimin, Yang, Changming, Huang, Guo, Zeng, Jin, Zhao, Junning·2025·Signal Transduction and Targeted Therapy

Abstract

The global pharmaceutical landscape remains dynamic and competitive, shaped by advancements in first-in-class therapies and breakthrough technologies. The United States has maintained its leadership in first-in-class therapies and breakthrough technologies, driven by advanced regulatory pathways, significant multinational corporation investments, a robust Research and Development (R&D) workforce, and continuous technological innovation. Additionally, global impact of the Food and Drug Administration (FDA) is further amplified through collaborations like Project Orbis, which facilitates simultaneous reviews of cancer treatments by multiple regulatory authorities worldwide. Europe, while historically strong, faces growing challenges in maintaining its competitive edge, particularly due to protracted regulatory timelines and complex coordination among its member states. In this competitive global environment, China has rapidly transformed from a generics-dominated market to a key player in innovative drug development. This article reviews China’s progress in innovative drug R&D from 2019 to 2023, emphasizing regulatory modernization, clinical trial advancements, and the emergence of novel therapies. By comparing China’s developments with above global counterparts, this review highlights the country’s achievements in regulatory efficiency, clinical trial progress, and the development of innovative therapies such as biologics and cell and gene therapies. Through this comparative analysis, the article underscores how China’s evolving policy-driven innovation ecosystem has positioned it as a growing leader in global drug development. The review examines how enhanced regulatory efficiency, clinical trial progress, manufacturing capabilities, and international collaboration have bolstered China’s growing influence, while also discussing the future opportunities and challenges it faces in shaping global pharmaceutical innovation and development.

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  • China's National Medical Products Administration has updated and strengthened its Technical Guidelines for Biological Drug Development, including cell and gene therapy products, to align with Quality of Biotechnological Products standards.

    “China’s National Medical Products Administration (NMPA) has updated and strengthened its “Technical Guidelines for Biological Drug Development”, including cell and gene therapy products to align with the Quality of Biotechnological Products standards [97].”

    From Genetic Insights into the Economic Toll of Cell Line Misidentification: A Comprehensive Review (2026) · cites this paper as [97]

    The Introduction and the section on regulatory measures describe NMPA regulatory modernization and adoption of ICH guidelines. The section on innovative-drug classification also reports revised registration classifications for biologics. Our copy does not say that NMPA updated the named “Technical Guidelines for Biological Drug Development,” that those guidelines include cell and gene therapy products, or that they were aligned with “Quality of Biotechnological Products” standards. (LLM, conf=0.84)

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200 of 518 shown

Cited by

Authors
Tan, R., Hua, H., Zhou, S., Yang, Z., Yang, C., Huang, G., Zeng, J., & Zhao, J.
Affiliations
  • National Medical Products Administration (CN)
  • National Center for Nanoscience and Technology (CN)
Corresponding author
Zhao, Junning
Venue
Signal Transduction and Targeted Therapy
Published
2025-07-22
Volume
10
Issue
1
Pages
220-220
ISSN
2059-3635 (ISSN-L)
OpenAlex
W4412535332
Cited by
51
References
27
Citations by year
2026: 44 · 2025: 7
FWCI
13.93
Type
journal article
Language
en
Open access
Locations
  • Signal Transduction and Targeted Therapy (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Biotechnology and Related Fields
  • Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
Keywords
new drug development, drug regulation, regulatory modernization, clinical trials, biologics, cell and gene therapy, first-in-class therapy, regulatory efficiency, pharmaceutical industry competitiveness, China pharmaceutical industry, international regulatory cooperation
MeSH terms
Drug Development, China, Drug Industry, Humans, United States, United States Food and Drug Administration

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