ReviewInvestigational new drugs2021
The drug lag issue: a 20-year review of China.
Review in Investigational new drugs, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
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
18 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Overall Survival Benefits of Cancer Drugs Approved in China From 2005 to 2020.JAMA network open · 2022Pooled it
- Epidemiological Characteristics, Target Distribution, and Clinical Value of Targeted Anticancer Drugs Approved in China: A Cross-Sectional Study.Clinical pharmacology and therapeutics · 2026Article
- Approval and delay status of United States -approved new drugs (2010-2023) in European Union, Japan, and China.BMC health services research · 2026Article
- Trends, lag and characteristics of rare disease drug approval in the USA and China, 1983-2022.Orphanet journal of rare diseases · 2025Article
- Regulatory efforts to address the access gap for foreign new drugs in China: the priority review program and related policies.Global health research and policy · 2025Article
- Regulatory flexibilities balancing unmet needs, benefits and risks in the approvals of imported cancer drugs in China: a cohort study from 2012 to 2021.The Lancet regional health. Western Pacific · 2025Article
- Characteristics of Drugs from Non-Global Companies for Hematologic Malignancies and Impact on Global Regulatory Approval.Clinical pharmacology and therapeutics · 2025Article
- Disparities in the access to immune checkpoint inhibitors approved in the United States, the European Union and mainland China: a serial cross-sectional study.BMJ public health · 2025Article
- Quantitative analysis of new drug registration policies for traditional Chinese medicine using the PMC index model.Frontiers in public health · 2025Article
- Quantitative evaluation and obstacle factor diagnosis of drug regulatory capacity in China.PloS one · 2025Article
- Evolution of traditional Chinese medicine registration review and approval policies: research based on the LDA topic model.Frontiers in public health · 2025Article
- Early access disparities in innovative therapies across the US, EU, China, and Japan.Frontiers in medicine · 2025Article
- Cancer drug indication approvals in China and the United States: a comparison of approval times and clinical benefit, 2001-2020.The Lancet regional health. Western Pacific · 2024Article
- From past to present: tracing the trends of diabetes drug trials in mainland China.Frontiers in endocrinology · 2024Article
- Asia-Inclusive Clinical Research and Development Enabled by Translational Science and Quantitative Clinical Pharmacology: Toward a Culture That Challenges the Status Quo.Clinical pharmacology and therapeutics · 2023Article
- Bridging the new drug access gap between China and the United States and its related policies.Frontiers in pharmacology · 2023Article
- The reimbursement decision speed for oncology new drugs in China and its determinant factors.Frontiers in public health · 2023Article
- Review time of oncology drugs and its underlying factors: an exploration in China.Frontiers in pharmacology · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
China has been criticized for the long drug delay for a long time. There was little understanding of Chinese drug lag formation from the investigational new drug (IND) submission to the new drug application (NDA) approval. Therefore, we analyzed the problem of drug lag in China cumulating from the clinical trial starting lag to the lags formed during the regulatory process and discerned the key underlying factors. After investigating the availability in China of new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) between 1999 and 2019, we find that even though cutting regulatory process could reduce the approval lag, the clinical trial starting time in China is more important in drug lag reduction than shortening development time and review time. The reduction of the regulatory process also needs continuous efforts by defining the clinical value based on the medical needs, regulatory procedure harmonization, and intensive discussions between applicants and regulators during the drug development process. Meanwhile, proactive approaches should be taken to encourage developing the first generics in China. More importantly, enhancing domestic research and development capabilities is still the key to cutting the drug lag. Moreover, the China National Medical Product Administration (NMPA) should attach importance to the accumulation of regulation experience on innovative drugs and transform the style of regulating generics to new drugs.
Indexed as
Identifiers
33928468What 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.