Facing up to China's vicissitudes

Faced with an additional two- to four-year delay for drug launches in China due to a new government interpretation of regulations governing multiregional clinical trials, global companies may want to consider partnering with domestic companies earlier in development.

Multinational pharma companies (MNCs) increasingly have been using multiregional clinical trials (MRCTs) to accelerate the lengthy drug approval process in China. Many sponsors now include Chinese patients in global Phase III trials rather than running a China-specific trial following U.S. or EU approval...