James SL, Abate D, Abate KH, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the global burden of disease study 2017. Lancet. 2018;392:1789–858.
Peng D, Sun J, Wang J, et al. Burden of skin disease—China, 1990–2019. CCDCW. 2021;3:472–5.
Zhou M, Wang H, Zeng X, et al. Mortality, morbidity, and risk factors in China and its provinces, 1990–2017: a systematic analysis for the global burden of disease study 2017. Lancet. 2019;394:1145–58.
Article PubMed PubMed Central Google Scholar
Wu JH, Cohen BA. The stigma of skin disease. Curr Opin Pediatr. 2019;31:509–14.
Jafferany M, Pastolero P. Psychiatric and psychological impact of chronic skin disease. Prim Care Companion CNS Disord. 2018. https://doi.org/10.4088/PCC.17nr02247.
Imafuku S, Zheng M, Tada Y, et al. Asian consensus on assessment and management of mild to moderate plaque psoriasis with topical therapy. J Dermatol. 2018;45:805–11.
Article PubMed PubMed Central Google Scholar
Kong Y, Xing P, Huai P, et al. The burden of skin diseases in China: global burden of disease study 2019. Arch Dermatol Res. 2024;316:277.
Ujiie H, Rosmarin D, Schön MP, et al. Unmet medical needs in chronic non-communicable inflammatory skin diseases. Front Med. 2022. https://doi.org/10.3389/fmed.2022.875492.
Chen S, Chen X, Liu M, et al. Regulation of generic drugs in China: progress and effect of the reform of the review and approval system. J Pharm Innov. 2023;18:340–8.
Zhong H, Ouyang D. The gap analysis between Chinese pharmaceutical academia and industry from 2000 to 2018. Scientometrics. 2020;122:1113–28.
Sun J, Hu CJ, Stuntz M, et al. A review of promoting access to medicines in China—problems and recommendations. BMC Health Serv Res. 2018;18:125.
Article PubMed PubMed Central Google Scholar
Wang M. Clinical trials and drug approvals continue to accelerate in China. Lancet Oncol. 2017;18:855.
Zhou Q, Chen X-Y, Yang Z-M, et al. The changing landscape of clinical trial and approval processes in China. Nat Rev Clin Oncol. 2017;14:577–83.
The State Council of the People’s Republic of China. Opinions of the State Council on the Reform of the Review and Approval Process for Drugs and Medical Devices (in Chinese), https://www.nmpa.gov.cn/directory/web/nmpa/zhuanti/ypqxgg/ggzhcfg/20150818101201640.html (2015, accessed 30 September 2024).
General Office of the CPC Central Committee and the General Office of the State Council. Opinions on Deepening the Reform of the Evaluation and Approval Systems to Encourage Innovation on Drugs and Medical Devices [in Chinese], http://www.gov.cn/zhengce/2017-10/08/content_5230105.htm (2017, accessed 25 September 2022).
Zhao Z, Pei Z, Hu A, et al. Analysis of incentive policies and initiatives on orphan drug development in China: challenges, reforms and implications. Orphanet J Rare Dis. 2023;18:220.
Article PubMed PubMed Central Google Scholar
People’s Daily. National Major Scientific and Technological Special Project for “Significant New Drugs Development” Achives Fruitful Results, https://www.gov.cn/xinwen/2019-08/01/content_5417723.htm (2019, accessed 28 November 2024).
Su X, Wang H, Zhao N, et al. Trends in innovative drug development in China. Nat Rev Drug Discov. 2022;21:709–10.
Su L, Liu S, Li G, et al. Trends and characteristics of new drug approvals in China, 2011–2021. Ther Innov Regul Sci. 2023;57:343–51.
China Food and Drug Administration. Announcement of the State Food and Drug Administration on the information platform for drug clinical studies (no. 28) (in Chinese), https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20130906120001263.html?type=pc&m= (2013, accessed 29 September 2024).
National Medical Products Administration. Requirements for Registration Classification and Application Dossiers of Chemical Drugs (No. 44 of 2020) (in Chinese), https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20200630180301525.html?type=pc&m= (accessed 27 November 2024).
National Medical Products Administration. Requirements for Registration Classification and Application Dossiers of Biological Products (No. 43 of 2020) (in Chinese), https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20200630175301552.html?type=pc&m= (accessed 27 November 2024).
The Office of the State Council of China. Opinions of the General Office of the State Council on the Consistency Evaluation of the Quality and Efficacy of Generic Drugs [2016] No. 8. (in Chinese), https://www.gov.cn/zhengce/zhengceku/2016-03/05/content_5049364.htm (2016, accessed 28 November 2024).
Patel SS, Huang KE, Fleischer AB, et al. Five-year trend in the number of dermatologic clinical drug trials registered on clinical trials.gov. J Drugs Dermatol. 2015;14:497–500.
Hu H, Lu X, Xu H, et al. Analysis of new drug registration and review in China in 2021. Acta Pharm Sin B. 2022;12:2127–8.
Article PubMed PubMed Central Google Scholar
Agten S, Wu B. Innovation in the Chinese Biopharma Sector: From Me-too to First-in-Class. In: Agten S, Wu B, editors. Biopharma in China: Innovation Trends and Dealmaking. Springer; 2024. p. 71–99.
Hu Y, Chen S, Qiu F, et al. Will the volume-based procurement policy promote pharmaceutical firms’ R&D investment in China? an event study approach. Int J Environ Res Public Health. 2021;18:12037.
Article PubMed PubMed Central Google Scholar
Wang N, Yang Y, Xu L, et al. Influence of Chinese national centralized drug procurement on the price of policy-related drugs: an interrupted time series analysis. BMC Public Health. 2021;21:1883.
Article PubMed PubMed Central Google Scholar
Chen L, Yang Y, Luo M, et al. The impacts of national centralized drug procurement policy on drug utilization and drug expenditures: the case of Shenzhen, China. Int J Environ Res Public Health. 2020;17:9415.
Article PubMed PubMed Central Google Scholar
Wang J, Yang Y, Xu L, et al. Impact of ‘4+7’ volume-based drug procurement on the use of policy-related original and generic drugs: a natural experimental study in China. BMJ Open. 2022;12:e054346.
Article PubMed PubMed Central Google Scholar
National Medical Products Administration. Guidelines for International Multicenter Drug Clinical Trials (Draft) (No. 2 of 2015) (in Chinese), https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20150130120001641.html?type=pc&m= (2015, accessed 28 November 2024).
Ramamoorthy A, Pacanowski MA, Bull J, et al. Racial/ethnic differences in drug disposition and response: review of recently approved drugs. Clin Pharmacol Ther. 2015;97:263–73.
Lo C, Nguyen S, Yang C, et al. Pharmacogenomics in Asian subpopulations and impacts on commonly prescribed medications. Clin Transl Sci. 2020;13:861–70.
Article PubMed PubMed Central Google Scholar
Ferguson JE, Seger EW, White J, et al. Racial/ethnic differences in treatment efficacy and safety for moderate-to-severe plaque psoriasis: a systematic review. Arch Dermatol Res. 2023;315:41–50.
Kaufman BP, Guttman-Yassky E, Alexis AF. Atopic dermatitis in diverse racial and ethnic groups-variations in epidemiology, genetics, clinical presentation and treatment. Exp Dermatol. 2018;27:340–57.
Shenoy P. Multi-regional clinical trials and global drug development. Perspect Clin Res. 2016;7:62–7.
Article PubMed PubMed Central Google Scholar
Huang N, Huang W, Luo Y, et al. China’s drug clinical trial institution record-keeping system: qualification requirements for PI are the key. Front Pharmacol. 2023. https://doi.org/10.3389/fphar.2023.1052977.
Article PubMed PubMed Central Google Scholar
Langan SM, Bourke JF, Silcocks P, et al. An exploratory prospective observational study of environmental factors exacerbating atopic eczema in children. Br J Dermatol. 2006;154:979–80.
Wang X, Li L-F, Zhao D-Y, et al. Prevalence and clinical features of atopic dermatitis in China. Biomed Res Int. 2016;2016:2568301.
Article PubMed PubMed Central Google Scholar
Li J, Mao D, Liu S, et al. Epidemiology of urticaria in China: a population-based study. Chin Med J (Engl). 2022;135:1369–75.
Xu L, Zhang L, Tian X, et al. Epidemiological research on inpatients with skin cancer in China (in Chinese). 中国循证医学杂志 2020; 20: 1280–1283.
Qu J, Huang Y, Lv X. Crisis of antimicrobial resistance in China: now and the future. Front Microbiol. 2019.
Comments (0)