There are now more local development and manufacturing activities in China as a result of both local innovation and cross-border technology transfers. As a result, the National Medical Products Administration (NMPA) is developing further GMP guidelines, for example for investigational products to be used in clinical trials, for blood products, and for certain novel therapies such as cell therapies.
The NMPA continues to conduct GMP inspections on foreign manufacturing sites during China’s COVID restrictions. These inspections are conducted remotely through video conference and are based on documents. A typical finding of these inspections has been noncompliance with Chinese GMP, or the Chinese product registration standards, particularly in relation to discrepancies between Chinese GMP and the GMP requirements of the country in which the manufacturing site is located.
There have also been a number of findings of noncompliance with Chinese product registration standards. These findings can lead to the NMPA imposing an import ban on the relevant products, and there may be limited recourse for companies seeking to challenge such an import ban. More important, we have increasingly seen that in these cases the products and the companies subject to the import ban are then disqualified — for a certain period of time — from participating in government-sponsored procurement programs for public hospitals in China.