RDPAC Calls For Chinese Post-marketing Surveillance For Biosimilars – Peking University Symposium
This article was originally published in PharmAsia News
China has yet to issue a clear regulatory pathway for biosimilars approvals. The existing, lower standard pathway has the branded industry calling for vigorous post-marketing measures to ensure safety.
You may also be interested in...
China has shown willingness to go tit-for-tat in its bilateral disputes with the US and the latest comments from US officials show an underlying distrust over clinical data and vaccines safety in China, raising fresh concerns just when collaboration is needed to accelerate availability of the first vaccines in the global pandemic.
As the largest manufacturer of active pharmaceutical ingredients globally, China is bracing for more uncertainty amid the global pandemic and fast-changing environment, particularly in the US.
Despite leading multinational pharma firms including AstraZeneca again delivering double-digit growth in China, the impact of coronavirus and an expanding volume-based purchasing scheme begin to surface.