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China has now included medically necessary medications for chronic and elderly diseases already approved abroad, along with innovative treatments for common and rare diseases, under its priority review and approval system. This move aims to fast-track the introduction of high-quality foreign products to meet existing clinical needs.
The country’s regulatory authority encourages international applicants to pursue synchronized global research and development and to submit simultaneous marketing applications for urgently needed drugs that are approved overseas, whether original or generic. Certain generic medications, if they meet specific standards, may be exempt from clinical trials, allowing developers to submit applications directly.
Back in 2018, the regulatory agency and the national health commission announced that new drugs launched in the U.S., European Union, or Japan within the last decade—yet unavailable in China—could be reviewed through expedited channels. These included treatments for rare conditions, severe life-threatening illnesses with no current effective options, and conditions that pose major clinical advantages.
To date, the authority has approved 81 imported new drugs across three batches, with 55 of these qualifying for priority review and approval, according to recent data.
The latest policy expands the scope of drugs eligible for expedited review to include both original and generic medicines. The agency will also publish a list of urgently needed treatments, removing restrictions on which drugs can qualify for this fast-track process.
To speed up reviews, the authority accepts various supporting data in marketing applications, including overseas registration data, post-marketing clinical and safety reports, benefit-risk assessments for cross-regional applications, and post-import risk management plans. It also encourages applicants to submit results from international multicenter clinical trials conducted domestically.
Regarding overseas generic drugs, there are different standards based on whether clinical trials were performed, with the agency clarifying that those meeting certain criteria can be approved without additional trials, enabling direct submission for marketing authorization.
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