China FDA aims to accelerate foreign drug approvals

| By | Pharmaceutical Industry
0
528

China’s food and drug authority is soliciting public feedback on a draft proposal to speed the process of approving foreign drugs to be sold in China.

The plan proposes the removal of the rule stating that foreign drugmakers have to wait until they enter stage II of clinical testing elsewhere before they can apply to start trials in China. This rule would still apply to vaccines.

Additionally, the plan states that foreign drugmakers can directly apply to register new drugs if the drugs have passed the International Multicenter Clinical Trial (IMCT) in China, rather than having to wait until the drugs are introduced to other markets before being imported to China.

The draft plan looks to hasten the introduction of new drugs from the U.S., Japan and European Union – as well as generics from India – to China’s population.

In addition to the streamlined review process, China has also been training more reviewers for imported drugs, with the number reaching 600 at the close of 2016.