[HTML][HTML] Evolution of drug regulations and regulatory innovation for anticancer drugs in China

Y Liu, N Zhang, C Xie, Y Jiang, Y Qin, L Zhou… - … Pharmaceutica Sinica B, 2022 - Elsevier
Over the past two decades, China has introduced significant changes to drug regulations
through regulatory innovations to accelerate drug review and approvals, keeping in line with …

The drug lag issue: a 20-year review of China

X Li, Y Yang - Investigational New Drugs, 2021 - Springer
China has been criticized for the long drug delay for a long time. There was little
understanding of Chinese drug lag formation from the investigational new drug (IND) …

Assessment of the delay in novel anticancer drugs between China and the United States: a comparative study of drugs approved between 2010 and 2021

X Luo, X Du, Z Li, F Qian, Y Yang - Clinical Pharmacology & …, 2023 - Wiley Online Library
Access to anticancer drugs has been a critical health issue in China for many years. We
retrospectively analyzed the novel anticancer drugs approved in the United States (US) …

The regulatory approvals of immune checkpoint inhibitors in China and the United States: A cross‐national comparison study

Y Jin, H Li, P Zhang, M Yu, H Zhang… - International Journal of …, 2023 - Wiley Online Library
Immune checkpoint inhibitors (ICIs) are currently one of the most popular treatment methods
for cancers. Several ICIs have been approved in China and the United States. We created a …

Drivers of start-up delays in global randomized clinical trials

J Lai, L Forney, DL Brinton, KN Simpson - Therapeutic innovation & …, 2021 - Springer
Background Global, randomized clinical trials are extremely complex. Trial start-up is a
critical phase and has many opportunities for delay which adversely impact the study …

[HTML][HTML] Policy updates on access to and affordability of innovative medicines in China

GG Liu, J Wu, X He, Y Jiang - Value in Health Regional Issues, 2022 - Elsevier
Abstract Introduction In China, efforts to qualify innovative medical products for
reimbursement used to be subject to substantial delays after regulatory approval due to …

Trends and characteristics of new drug approvals in China, 2011–2021

L Su, S Liu, G Li, C Xie, H Yang, Y Liu, C Yin… - … Innovation & Regulatory …, 2023 - Springer
Background In the past decade, the Chinese drug regulatory system has undergone many
changes. A major reform starting in 2015 has significantly reshaped the regulatory …

Innovation in a science-based sector

Y Zhou, AE Coplin - China Review, 2022 - JSTOR
Biologics are one of the fastest growing fields in the biomedical industry. Producing these
innovative drugs has proven both technologically and politically challenging, however …

Pathway to approval of innovative radiopharmaceuticals in China

S An, L Wang, F Xie, D Jiang, G Huang… - Journal of Nuclear …, 2024 - Soc Nuclear Med
Since the late 1950s, radiopharmaceuticals have been used for diagnosis and treatment in
clinical nuclear medicine in China. Over the decades, China has successfully established a …

Pediatric drug development in China: Reforms and challenges

W Wu, Z Tang, J Chen, Y Gao - Pharmacological Research, 2019 - Elsevier
In China, child and adolescent pediatricians often face challenges in treating children with
the appropriate medications. Within the last 8 years, the Chinese government has already …