Comparison of the accelerated marketing and registration system for innovative drugs in countries along"The Belt and Road"and its implications
YUAN Fang-zhe
HAN Jia-jia
YANG Feng-hong
WANG Xi-rui
CHEN Yue-jiao
CHU Shu-zhen
Abstract：Benefiting from the encouragement and guidance of the policy and the improvement of the mechanism,China's pharmaceutical innovation capacity has been continuously improved. On the background of the deepening the cooperation of"The Belt and Road",China's innovative drugs actively broaden their horizons and choose to enter more diversified overseas markets. The paper conducts a comparative study on the accelerated listing and registration system of innovative drugs in three countries along"The Belt and Road",namely,Singapore,Malaysia and Saudi Arabia. We find that although there are commonalities in accelerating the listing and registration of drugs in each country,there are also differences in the design and implementation details of the system. For example,Singapore and Malaysia emphasize international cooperation on drug regulatory mutual trust,while Saudi Arabia and China have established breakthrough therapy programs to enhance early communication and facilitate local innovative drug development. By analyzing the scope and process of system application in each country,this paper puts forward some suggestions,such as precising market positioning,optimizing marketing strategy and building cooperation and exchange platform for innovative drugs,aiming to provide strong support for the rapid market expansion of China's innovative medicines in the countries along the"The Belt and Road".
Keywords：drug registrationinnovative drug applicationpriority reviewSingaporeMalaysiaSaudi Arabia
Publication Date：2025-01-14
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 12-19 )