Innovative drug availability in China

Shao, Liming; Xu, Lili; Li, Qiu; Chakravarthy, Ranjana; Yang, Ziling; Kaitin, Kenneth I.

doi:10.1038/nrd.2016.200

Cited by 24 publications

(26 citation statements)

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“…In recent years, the Chinese government has taken great strides to expedite the drug approval process by enacting a host of regulatory reforms ( Table ) . Registration fees were increased 10‐fold in 2015.…”

Section: Regulatory Environment In Chinamentioning

confidence: 99%

Challenges and Opportunities With Oncology Drug Development in China

Bajaj

Gupta

Wang³

et al. 2018

Clin Pharma and Therapeutics

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Section: Regulatory Environment In Chinamentioning

confidence: 99%

Challenges and Opportunities With Oncology Drug Development in China

Bajaj

Gupta

Wang³

et al. 2018

Clin Pharma and Therapeutics

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“…48 With potentially fewer therapy-related toxicities, novel agents, such as molecularly targeted drugs and immunotherapy, hold promise for children with cancers. 4 Notwithstanding the development of innovative cancer drugs for adult use in China, 49 our study indicated that availability of new anticancer medications for children can be improved. Initial approvals of the four targeted drugs with paediatric indications approved by the NMPA were delayed compared to the United States.…”

Section: Approvals Of Childhood Cancer Drugs In China and The United Statesmentioning

confidence: 86%

Childhood cancer drugs in China: An overview and comparison of regulatory approvals in China and the United States

Zhang

Wagner

Han

et al. 2021

Intl Journal of Cancer

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Different from less developed countries, 80% of children with cancers in the United States are cured. Traditional chemotherapy drugs are the mainstay of therapies; new targeted medications have become available recently. Using publicly available data, we created a database of cancer drugs with paediatric malignancy indications approved by 31 October 2020 in China and the United States. We compared numbers, type, indications and listing on the World Health Organization Model List of Essential Medicines for Children (WHO EMLc) between the two countries, assessed the correlation between paediatric indications and cancer incidences, and described evidence supporting approvals of targeted medications in the two settings. Our study showed that by 31 October 2020, 31 and 39 cancer drugs available in China and the United States were approved for use in children, corresponding to 137 and 102 paediatric cancer indications, respectively. About half of these drugs (17 in China and 18 in the United States) were listed on the WHO EMLc. The correlation between indications and burden of disease was higher in the United States (r = 0.68) than China (r = 0.59). More traditional chemotherapy drugs were approved in China (n = 27) than the United States (n = 19). Of 20 targeted childhood anticancer medicines approved in the United States, mainly on the basis of single arm trials (27/32 indications, 84.4%), only four were approved for paediatric indications in China, at a median of 2.8 years after US Food and Drug Administration approval.A harmonised, evidence-based regulatory framework is needed to ensure approvals of needed, safe and efficacious childhood cancer drugs across the world.

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“…The rapid increase in the number of drug clinical trials and R&D activities on innovative drugs for the treatment of ischemic stroke is largely attributable to the policies initiated by the Chinese government. 23 Since 2008, the Chinese government has launched national major projects for new drugs by improving the procedure of review and approval process. By 2015, the Chinese government established several reform policies 10,24 that prioritize the review process for innovative drugs.…”

Section: Discussionmentioning

confidence: 99%

Evolution of ischemic stroke drug clinical trials in mainland China from 2005 to 2021

Wang

Hou

et al. 2022

CNS Neurosci Ther

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Background: To assess the temporal changes in the characteristics of ischemic stroke drug clinical trials conducted in mainland China in 2005-2021. Methods: A statistical analysis of registered clinical trials on ischemic stroke was performed using the platform of the Center for Drug Evaluation of China National Medical Products Administration, the Chinese Clinical Trial Registry, and Clini calTr ials.gov websites.

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Innovative drug availability in China

Cited by 24 publications

References 0 publications

Challenges and Opportunities With Oncology Drug Development in China

Challenges and Opportunities With Oncology Drug Development in China

Childhood cancer drugs in China: An overview and comparison of regulatory approvals in China and the United States

Evolution of ischemic stroke drug clinical trials in mainland China from 2005 to 2021

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