Research |


Yang Yue obtained her BS and PhD degree from Shenyang Pharmaceutical University in 1995 and 2004, respectively. She is the first recipient of a PhD in the field of Pharmaceutical administration in China. She was a professor and PhD supervisor at Shenyang Pharmaceutical University (2011.11-2020.9). In October 2020, She joined School of Pharmaceutical Sciences of Tsinghua University as a research professor and PhD supervisor(Social and administrative pharmacy under discipline of pharmacy). Currently, she is the leader of the discipline of drug regulatory science, the director of the Institute of Drug Regulatory Sciences, School of Pharmaceutical Science , Tsinghua University. Also, she is the director of the Key Laboratory of Innovative Drug Research and Evaluation of National Medical Products Administration. Dr. Yang is a concurrent PhD supervisor at Hainan University (joint MS and PhD with Hainan Real World Data Research Institute) and an expert of the National Health Security Administration's Pharmaceutical Price and Tender Procurement .

Research Interests

Dr. Yang is mainly engaged in drug regulatory sciences and top-level design of drug policies and systems, and research on optimization of regulatory pathways and procedures. She is also interested in research on new tools, standards and methods for evaluating the safety, efficacy and quality of novel drugs, generic drugs (biosimilars), and drugs for rare diseases. The research scope covers the whole life cycle of drugs. Since joining Tsinghua University in October 2020, she has led 32 programs for the National Medical Products Administration (NMPA), Bill & Melinda Gates Foundation, Hainan Medical Products Administration, Guangdong Medical Administration, Industry associations, and top domestic and international pharmaceutical companies. During the period, she has published 10 SCI papers and 32 papers in core Chinese journals of Peking University as corresponding author.

Her representative books include "Research On Drug Regulatory Science of United States", " Navigation of Drug Marketing Application Holder System", "Research and Application of WHO Essential Drug System". She has edited the book "Reform of Pharmaceutical Raw Materials and Packaging Materials Related Review", "Reform and Innovation of Drug Clinical Trial Dynamic Management", "21st Century Cures Act", "FDA Responsibilities and Powers", etc.

Scientific Contributions

Dr. Yang has conducted in-depth research on the theory and scientific logic of regulatory science, and has developed a unique system of research and methodology of reflection. She has established a basic research framework of systems, pathways, procedures, regulatory science tools, standards and methods, and proposed that drug regulatory science is based on comparative decision-making. She is also interested in drug administration policy and legislation, and participated as a core expert in the formulation and revision of the“Drug Administration Law of the People's Republic of China”and“Vaccine Administration Law of the People’s Republic of China”. She has served as an expert in the validation and consultation of the drug marketing authorization holder (MAH) system, the Patent linkage system, the Patent compensation system, the drug Data exclusivity system, the registration and incentive of rare disease drug R&D, and the reform of the biologics registration and classification system.

Selected Publications

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).