Evidence map›Paper›PMID 36561995›Full record

ReviewActa pharmaceutica Sinica. B2022

Evolution of drug regulations and regulatory innovation for anticancer drugs in China.

Yang Liu, Ning Zhang, Cuicui Xie, Yale Jiang, Yunhe Qin, Liyun Zhou, Yi Fan, Lianjie Ren, Chen Yin, Huan Yang and 5 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Acta pharmaceutica Sinica. B, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Yang LiuTsinghua Clinical Research Institute (TCRI), School of Medicine, Tsinghua University, Beijing 100084, China.
Ning ZhangCenter for Drug Evaluation, National Medical Products Administration, Beijing 100038, China.
Cuicui XiePharmcube (Beijing) Co., Ltd., Beijing 100102, China.
Yale JiangTsinghua Clinical Research Institute (TCRI), School of Medicine, Tsinghua University, Beijing 100084, China.
Yunhe QinPharmcube (Beijing) Co., Ltd., Beijing 100102, China.
Liyun ZhouPharmcube (Beijing) Co., Ltd., Beijing 100102, China.
Yi FanCenter for Drug Evaluation, National Medical Products Administration, Beijing 100038, China.
Lianjie RenCenter for Drug Evaluation, National Medical Products Administration, Beijing 100038, China.
Chen YinTsinghua Clinical Research Institute (TCRI), School of Medicine, Tsinghua University, Beijing 100084, China.
Huan YangCenter for Drug Evaluation, National Medical Products Administration, Beijing 100038, China.
Wei XiePharmcube (Beijing) Co., Ltd., Beijing 100102, China.
Qing ZhaiDepartment of Clinical Pharmacy, Cancer Hospital of Fudan University, Shanghai 200032, China.
Guanqiao LiVanke School of Public Health, Tsinghua University, Beijing 100084, China.
Hongzhuan ChenShanghai Collaborative Innovation Center for Translational Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.
Xiaoyuan ChenTsinghua Clinical Research Institute (TCRI), School of Medicine, Tsinghua University, Beijing 100084, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Over the past two decades, China has introduced significant changes to drug regulations through regulatory innovations to accelerate drug review and approvals, keeping in line with the rapidly growing scientific innovation in drug research and development (R&D). In this study, we outlined the revolution of drug regulation in China since the establishment of the State Drug Administration in 1998. More particularly, we performed a comprehensive analysis of newly approved anticancer drugs in China from the year 2005 to May 2021, as a powerful illustration of how the revolution has changed the drug R&D landscape. Innovative drug development in China has boomed, benefiting in particular from pro-innovation policies as well as expedited program designations by the authority. We found a significant increase in the number of both imported and domestic new anticancer drugs from 2005 to 2021, with the emergence of drugs with novel mechanisms of action, including immune checkpoint inhibitors and cell therapy products. Drug lag has also been dramatically shortened by more than 70% for imported drugs in years 2016-2020 compared to years 2006-2010. Furthermore, we provide an insight into the potential approaches to further optimize the science-based and clinical value-based regulatory and R&D drug ecosystem in China. This review provides evidence of significant impacts of regulations and policies on drug R&D and suggests that the constantly adapting regulatory ecosystem will speed up drug development in China and worldwide.

Indexed as

Anticancer drugsDrug lagDrug R&DExpedited program designationsGlobalizationInnovative drugsRegulatory innovationsUnmet medical need

Identifiers

PMID36561995
PMCPMC9764065

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.