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The evolving regulatory system of advanced therapy medicinal products in China: a documentary analysis using the World Health Organization Global Benchmarking Tool standards Journal article
Shi, Junnan, Chen, Xianwen, Hu, Hao, Ung, Carolina Oi Lam. The evolving regulatory system of advanced therapy medicinal products in China: a documentary analysis using the World Health Organization Global Benchmarking Tool standards[J]. Cytotherapy, 2024, 26(8), 954-966.
Authors:  Shi, Junnan;  Chen, Xianwen;  Hu, Hao;  Ung, Carolina Oi Lam
Favorite | TC[WOS]:1 TC[Scopus]:1  IF:3.7/4.3 | Submit date：2024/06/05
Advanced Therapy Medicinal Products  China  Drug Regulatory Authority  Global Benchmarking Tool (Gbt)  Regulatory Science  
Application of implementation science framework to develop and adopt regulatory science in different national regulatory authorities Review article
2023
Authors:  Shi,Junnan;  Chen,Xianwen;  Hu,Hao;  Ung,Carolina Oi Lam
Favorite | TC[WOS]:0 TC[Scopus]:2  IF:3.0/3.6 | Submit date：2023/08/03
China  Drug Regulatory Authorities (Dras)  European Union  Implementation Science  Japan  Precede-proceed Model (Ppm)  Regulatory Science  The United States (Us)  
Integrating real-world evidence in the regulatory decision-making process: a systematic documentary analysis of experiences in the US, EU and China using a logic model Journal article
Li, Meng, Chen, Shengqi, Lai, Yunfeng, Liang, Zuanji, Wang, Jiaqi, Shi, Junnan, Lin, Haojie, Yao, Dongning, Hu, Hao, Ung, Carolina Oi Lam. Integrating real-world evidence in the regulatory decision-making process: a systematic documentary analysis of experiences in the US, EU and China using a logic model[J]. Frontiers in Medicine, 2021, 8, 669509.
Authors:  Li, Meng;  Chen, Shengqi;  Lai, Yunfeng;  Liang, Zuanji;  Wang, Jiaqi; et al.
Favorite | TC[WOS]:23 TC[Scopus]:30  IF:3.1/3.4 | Submit date：2022/07/27
Regulatory Science  Real-world Evidence  Decision-making  Logic Model  Regulation  
Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model Journal article
Li, Meng, Chen, Shengqi, Lai, Yunfeng, Liang, Zuanji, Wang, Jiaqi, Shi, Junnan, Lin, Haojie, Yao, Dongning, Hu, Hao, Ung, Carolina Oi Lam. Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model[J]. Frontiers in Medicine, 2021, 8, 669509.
Authors:  Li, Meng;  Chen, Shengqi;  Lai, Yunfeng;  Liang, Zuanji;  Wang, Jiaqi; et al.
Favorite | TC[WOS]:23 TC[Scopus]:30  IF:3.1/3.4 | Submit date：2021/12/07
Decision-making  Logic Model  Real-world Evidence  Regulation  Regulatory Science  
Applying regulatory science in traditional chinese medicines for improving public safety and facilitating innovation in China: a scoping review and regulatory implications Review article
2021
Authors:  Liang, Zuanji;  Lai, Yunfeng;  Li, Meng;  Shi, Junnan;  Lei, Chi Ieong; et al.
Favorite | TC[WOS]:17 TC[Scopus]:22  IF:5.3/5.5 | Submit date：2021/12/09
China  Drug Regulatory Authority  National Medical Products Administration  Regulatory Science  Tcm  Traditional Medicine