China’s pharmaceutical market is 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.
Pharmaceutical companies seeking to develop, manufacture and sell new pharmaceuticals in China should benefit from new regulations that came into effect on 1 July 2020.
Streamlined approvals – including for urgently needed drugs – may benefit Australian companies looking to expand into China. Faster turnaround times for clinical trial applications are likely to expand opportunities to conduct pharmaceutical research and development (R&D) in China.
Four new channels for drugs approval
Following several years of public consultation, two new sets of regulations have been adopted under the newly amended Drug Administration Law. The two areas that have been substantively amended are the Drug Registration Regulation, and the Drug Manufacturing Supervision Regulation.
One of the highlights of the new regulations is to make new treatments more readily available by introducing four fast-track channels for drug approval and listing. These four approval channels are: ‘breakthrough therapy approval’; ‘conditional approval’; ‘priority review and approval’; and ‘special review and approval’.
On 8 July 2020, the National Medical Products Administration (NMPA) announced how these updated approval channels would work. Overseas companies can utilise these new channels to licence and sell drugs that treat life-threatening conditions. In addition, companies can also use the new approval channels for drugs