Fast track approvals in China’s drugs market to unlock pharma prospects


A new Austrade insights paper has been released updating the life sciences sector on how to fast track approvals in China’s drugs market to unlock pharma prospects.

New Chinese regulations came into effect on 1 July 2020, and biotech and pharma companies seeking to expand by developing, manufacturing or selling new pharmaceuticals in China could benefit from them.

The new rules intend to significantly ease entry requirements for overseas pharma companies wishing to sell treatments in China. They may also ease regulatory burdens on Australian biotech companies that want to explore opportunities to conduct simultaneous R&D projects in China.

Austrade’s insights paper includes summary guidance on the new channels for drugs approval, faster approval turnaround times, expedited clinical trial applications, the ability to outsource production, and changes to reimbursement.

China is considered Asia’s number one biopharma cluster. Its pharmaceutical market expected to be worth over US$160 billion by 2023, which is around 30 per cent of the total global market – according to market research firm Daxue.

A significant proportion of newly-approved drugs in recent years have been produced by overseas companies. Approval processes have become more rapid and streamlined in recent years. The number of pending drug registration applications dropped from nearly 22,000 at the peak of September 2015 to 3,440 by the end of 2018.

Find out more about registering pharmaceuticals products in China and connect with Austrade officials by reading the paper here.