(Yicai) Jan. 8 -- China will now include, in addition to common and rare disease drugs, certain overseas-marketed novel and generic treatments for chronic conditions and age-related diseases in its fast-track approvals process, with the aim of getting effective drugs to Chinese patients faster.

The National Medical Products Administration said yesterday that it will encourage companies to seek approval in China for innovative and generic drugs already sold overseas that meet urgent clinical needs, and urges applicants to pursue globally synchronized drug development and approval filings.

Generic drugs that meet certain requirements may be exempt from clinical trials, allowing developers to submit marketing applications directly, the regulator added.

The NMPA and the National Health Commission created a special review channel in 2018 for three categories of new drugs already approved in the United States, the European Union, and Japan within the previous 10 years but not yet in China. They are drugs for rare diseases, for life-threatening conditions with no effective treatment or preventions, and for life-threatening conditions with clear clinical advantages.

Following that, the NMPA has issued three lists of clinically urgent overseas new drugs covering 81 varieties. According to its most recent figures, 55 of those have been approved through the priority review process and are available in China.

The latest move expands the priority review and approvals scope for overseas-marketed drugs to include novel and generic treatments. The NMPA also said it will not limit priority review eligibility by "publishing a list of such urgently needed treatments.”

To speed reviews, the NMPA said applicants may rely on overseas registration and clinical data, including full clinical, pharmaceutical and non-clinical dossiers, post-marketing safety reports, benefit-risk analyses across populations, and post-import risk-management plans, including post-marketing study plans.

The agency also encourages submission of data from international multicenter clinical trials conducted in China, it said.

Because overseas generic drugs differ in whether they were tested in clinical trials abroad, the NMPA clarified that applicants who meet the announcement’s requirements may, after assessment, be granted an exemption from domestic clinical trials, enabling immediate submission of an application for marketing authorization.

Editor: Martin Kadiev