China's Clinical Trial Pilots Open Path to Global Simultaneous Development

At the end of July 2024, China launched a new round of clinical trial reforms, followed by an unprecedented pace of implementation. Local pilot programmes were introduced within days, and pilot hospitals designated within weeks. These rapid policy actions highlight Chinese regulators’ recent efforts to address the country's deficit in meeting global standards. As a result, multinationals are now anticipating the possibility of including China in more global simultaneous development and submission (i.e. using multiregional clinical trials).

On 31 July, the National Medical Products Administration (NMPA) launched a pilot programme to reduce the review and approval timeline for clinical trial applications of certain Class 1 innovative drugs from 60 working days down to 30. The initiation of clinical trials (i.e. when the first patient is enlisted), could now be accelerated to 12 weeks, down from as long as 40 weeks previously. These expedited timelines are expected to save enterprises two to four months in R&D.

Within three days, on 2 August, Beijing and Shanghai were designated as the first pilot cities. By 15 August, the two cities had announced a total of 31 pilot hospitals. By 23 August, 18 of these hospitals had made their required application procedures known for clinical trials to be conducted at their institutions. Since China launched a new round of pharmaceutical regulatory system reforms in 2015, the clinical trial timeline has been substantially shortened. Application approval was reduced from up to three years to as little as three months. However, drug releases in China face a significant delay compared to advanced economies, hindering the development and launch strategies of both multinationals and Chinese enterprises.

For example, the drug approval lag – the time between new drug approval in China and the first international approval, typically in the US – has improved, decreasing from an average of 6.3 years in 2018 to 4.4 years in 2022.1 However, it remains a significant challenge for multinationals. Among other hurdles, clinical trial initiation takes an average of 20 weeks globally but is approximately 40 weeks in China.2 In response, multinationals have made global simultaneous development and submission a priority.

The new policies – as well as their efficient execution – have generated excitement in the market. Multinationals have either updated their schedules for achieving 100 percent global simultaneous development or have already claimed success for certain pipelines. Meanwhile, enterprises are urging clinical trial organisations to enhance their capabilities and capacities, while calling on the government to provide incentives for these organisations to further facilitate China’s involvement in global simultaneous development and submission.