Center for Drug Evaluation, National Medicine Products Administration, China.
Johnson & Johnson Innovative Medicine, Beijing, China.
Adv Drug Deliv Rev. 2024 Nov;214:115459. doi: 10.1016/j.addr.2024.115459. Epub 2024 Oct 9.
In the past decade, biopharmaceutical research and development in China has been notably boosted by government policies, regulatory initiatives and increasing investments in life sciences. With regulatory agency acting as a strong driver, model-informed drug development (MIDD) is transitioning rapidly from an academic pursuit to a critical component of innovative drug discovery and development within the country. In this article, we provided a cross-sectional summary on the current status of MIDD implementations across early and late-stage drug development in China, illustrated by case examples. We also shared insights into regulatory policy development and decision-making. Various modeling and simulation approaches were presented across a range of applications. Furthermore, the challenges and opportunities of MIDD in China were discussed and compared with other regions where these practices have a more established history. Through this analysis, we highlighted the potential of MIDD to enhance drug development efficiency and effectiveness in China's evolving pharmaceutical landscape.
在过去的十年中，中国政府的政策、监管举措以及对生命科学领域的投资不断增加，推动了生物医药研发的显著发展。监管机构是强大的推动力，模型指导的药物研发（MIDD）正在迅速从学术追求转变为中国创新药物发现和开发的关键组成部分。本文通过案例说明了中国在药物研发的早期和晚期阶段，MIDD 实施的现状，并分享了对监管政策制定和决策的见解。展示了各种建模和模拟方法在广泛应用中的应用。此外，还讨论了 MIDD 在我国的挑战和机遇，并与其他具有更成熟实践经验的地区进行了比较。通过分析，我们强调了 MIDD 在中国不断发展的制药领域提高药物开发效率和效果的潜力。
