On February 7th, China FDA released the finalized Special Review and Approval Procedure for innovative Medical Devices. It allows both domestic and international manufactures to apply for accelerated approval.
The new regulation promises early involvement, dedicated personnel and active communication with all applicants, and a science-based review to help speed up review time for qualified devices. When compared to the draft version, the new regulation has two significant changes:
- No longer does the qualified applicant have to apply for and obtain a patent in China. This requirement no states that patent holders need only to apply for a patent and be recognized by the patent office at China State Council.
- The regulation also removes the restriction that only devices made in China were candidates for the accelerated review pathway. There was significant pressure applied by the U.S. and E.U. governments along with industry associations and China changed the wording to allow both domestic and foreign device makers to apply for the accelerated review process.
However, concerns still remain as several aspects of the accelerated process remain murky, leaving room for interpretation. China FDA defines an innovative device using the following criteria:
- Applicants hold patents for the core technology or the patent application has been recognized by China State Council’s patent agency;
- The operational rational or working mechanism is “domestically initiated” in China, and efficacy or safety should be fundamentally improved compared to similar products on the market to ensure significant clinical value; and
- The applicant has completed initial research with complete and traceable data and has a product prototype.
According to an article in “The Gray Sheet” the second requirement has the industry worried that domestic device makers will be preferred over multinational companies. The Chinese government has set a national goal of encouraging domestic innovation and import substation of costly devices to help contain growing medical expenditures.
Beyond the aforementioned concerns, many are concerned over how fast China FDA will prioritize the review process and whether the intended acceleration will materialize.
Let us know your thoughts on China FDA’s fast-track review process.
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