ArticleMedComm2023
Advanced therapy medicinal products in China: Regulation and development.
Article in MedComm, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed.
- Advanced therapy medicinal products in Saudi Arabia: Regulation and development.Regenerative therapy · 2026Review
- Engineering high-fidelity bone organoids: Operational classification, multilineage crosstalk, biofabrication evidence, and translational validation.Materials today. Bio · 2026Article
- Regulatory Convergence in Cell and Gene Therapy: Harmonizing Quality, CMC, and Approval Pathways Across the FDA, EMA, PMDA, and Emerging Markets.Biotech (Basel (Switzerland)) · 2026Review
- Review
- Bacteriophage-Based Therapeutic, Diagnostic, and Biocontrol Platforms: Engineering, Evidence, and Translational Challenges.International journal of molecular sciences · 2026Review
- Current landscape of innovative drug development and regulatory support in China.Signal transduction and targeted therapy · 2025Review
- Living Medicines Engineered to Fight: A Comprehensive Review on CAR T-Cell Therapy.International journal of hematology-oncology and stem cell research · 2025Review
- Clinical trials to gene therapy development and production in Brazil: a review.Lancet regional health. Americas · 2025Review
- The design of retroviral vectors used in the CAR-T products, risk management, and future perspective.MedComm · 2025Article
- Bioengineering breakthroughs: The impact of stem cell models on advanced therapy medicinal product development.World journal of stem cells · 2024Review
- Post-marketing surveillance framework of cell and gene therapy products in the European Union, the United States, Japan, South Korea and China: a comparative study.BMC medicine · 2024Article
- The current socioeconomic and regulatory landscape of immune effector cell therapies.Frontiers in medicine · 2024Review
- Article
- Regulations of phage therapy across the world.Frontiers in microbiology · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Advanced therapy medicinal products (ATMPs) have shown dramatic efficacy in addressing serious diseases over the past decade. With the acceleration and deepening of China's drug regulatory reforms, the country sees a continuous introduction of policies that encourage drug innovation. The capacity and efficiency of the Center for Drug Evaluation (CDE), National Medical Products Administration have significantly improved, where substantial resources have been allocated to ATMPs with major innovations and outstanding clinical values that satisfy urgent clinical needs. These changes have greatly stimulated the research and development of biological products in China, ushering in a period of explosive growth in the number of investigational new drug (IND) applications of ATMPs. Here, we described China's ATMP regulatory framework and analyzed data on IND applications for ATMPs submitted to CDE. The data show that China's ATMP industry is expanding dramatically, but lagging behind in terms of the innovative targets and the coverage of indications. However, in recent years, the diversity of product types, targets, and indications is growing. We discussed challenges and opportunities in ATMP regulation. Risk-based regulation and cross-discipline collaborations are encouraged to promote more ATMPs toward market authorization in China.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.