研究方向
药品监管科学是国际新兴前沿交叉学科，是监管机构利用有限的已知科学（证据）去进行面向未来决策的工具，其核心是将科学发现转化为监管证据或者依据，纳入监管审评视野。监管科学的核心领域是开发新的测量和评价工具、标准、方法。监管科学以监管理念、法律法规、监管机制、监管程序为基础。
截至2020年10月，杨悦共主持国家卫生健康委、国家市场监管总局、国家药品监督管理局及事业单位的纵向和横向科研项目90余项。
自任教以来发表期刊论文总数达400余篇，其中SCI论文4篇。代表性著作有专著《美国药品监管科学研究》《药品上市许可持有人制度导读》《WHO基本药物制度研究与应用》。编著《药用原辅料和包装材料关联审评改革》《药物临床试验动态管理改革与创新》《21世纪治愈法案》《FDA职责与权力》等。
科学贡献
在监管科学的理论、科学逻辑方面进行了深入的研究，形成了独特的研究和思维方法论体系，建立了制度、路径、程序、监管科学工具、标准和方法的基本研究框架，提出药品监管科学是基于比较的决策。在药品管理政策和立法方面具有很深的造诣，作为核心专家参与《药品管理法》《疫苗管理法》制修订工作，并作为药品上市许可持有人制度、专利链接制度、专利补偿制度、药品数据保护制度、罕见病药物研发注册与激励、儿童用药研发注册与激励、生物制品注册分类制度改革等的论证和咨询专家。
代表性论文
1.Luo X, Guo Q, Du X, Huang L, Chow SC*, Yang Y*. Evaluation of clinical trial designs for novel anticancer drugs in China: a cohort study of drugs approved between 2015 and 2021. Drug Discov Today. 2023 Mar 31:103578.
2.Luo X, Du X, Huang L, Guo Q, Tan R, Zhou Y, Li Z, Xue X, Li T, Le K, Qian F, Chow SC*, Yang Y*. The price, efficacy, and safety of within-class targeted anticancer medicines between domestic and imported drugs in China: a comparative analysis. Lancet Reg Health West Pac. 2022;32:100670.
3.Luo X, Du X, Li Z, Qian F, Yang Y*. Assessment of the Delay in Novel Anticancer Drugs between China and the United States: A Comparative Study of Drugs Approved between 2010 and 2021. Clin Pharmacol Ther. 2023;113(1):170-181.
4.Luo X, Yang L, Du X, Yang J, Qian F, Yang Y*. Analysis of Patent and Regulatory Exclusivity for Novel Agents in China and the United States: A Cohort Study of Drugs Approved Between 2018 and 2021. Clin Pharmacol Ther. 2022;112(2):335-343.
5.Luo X, Qian F, Yang L, Li Y, Yang Y*. Assessment of the breakthrough-therapy-designated drugs granted in China: A pooled analysis 2020-2022. Drug Discov Today. 2022;27(12):103370.
6.Li Y, Jiang Y, Wang H, Zhang L, Yang Y*. Safety-Related Drug Withdrawals in China Between 1999 and 2021: A Systematic Investigation and Analysis. Drug Saf 45, 737–745 (2022).
7.Chen, S., Chen, X., Liu, M, Xu Z, Yang Y*. Regulation of Generic Drugs in China: Progress and Effect of the Reform of the Review and Approval System. J Pharm Innov (2022).
8.Aslam F, Babar ZU, Madni A, Asghar M, Yang Y*. Unveiling and addressing implementation barriers of vaccination communication strategy: Perspectives from government officials at national and provincial levels. Hum Vaccin Immunother. 2022 Dec 30;18(7):2153513.
9.Aslam F, Ali I, Babar Z, Yang Y. Building evidence for improving vaccine adoption and uptake of childhood vaccinations in low- and middle-income countries: a systematic review. Drugs Ther Perspect. 2022;38(3):133-145.
10.Li, X., Yang, Y. The drug lag issue: a 20-year review of China. Invest New Drugs 39, 1389–1398 (2021).
