Chinese FDA To Allow Priority Reviews Of Medical Devices In 2017
The China Food and Drug Administration (CFDA) has announced that the agency will begin accepting priority review applications for medical devices beginning in January 2017. The new policy is the latest effort in the Chinese government’s ongoing commitment to regulatory reform.
In a survey conducted by Forbes in 2015, 86 percent of top multinational pharmaceutical companies said that reforms within the CFDA would be “essential” for their company’s future business in China. In recent weeks, Forbes reported that CFDA has made significant strides to be more transparent about inadequacies in its regulatory process, principally with clinical data collection.
Earlier this month, the CFDA released an expanded list of medical devices that will not be required to undergo the country’s more stringent clinical trial requirements. In June, CFDA launched new medical device clinical trial guidelines to clarify the regulatory processes for both local and multinational device manufacturers operating in China.
Even with additional clarity, the Chinese regulatory process can take up to 14 months to complete, noted Miriam Dabraowa, analyst from WILDDESIGN, in a recent MDO guest column. For certain devices, that process may soon be expedited. CFDA drafted new policy in June that will facilitate priority reviews for certain devices, and that policy is set to go into effect in January 2017.
Manufacturers importing class II devices, and both domestic and multinational companies with class III devices, soon will be able to request a priority review if certain conditions are met, according to Regulatory Affairs Professionals Society (RAPS), citing law firm Ropes & Gray. Devices enrolled in the National Science and Technology Major Project or National Key Research and Development Plan can apply for priority review, as can devices designed to offer “significant advantages in clinical practice.”
The policy highlights devices that treat rare disease, malignant tumors, and common diseases affecting both elderly and pediatric patients that have few or no alternative treatments. Devices that address “urgent clinical need” could also receive expedited review by the CFDA. Decisions on priority applications will be made by the CFDA’s Center for Medical Device Evaluation (CMDE), and manufacturers of prioritized devices will be eligible to receive additional interactions with CMDE.
Ropes & Gray commented that the most recent policy joins other new policies that seek to streamline and expedite the regulatory process, particularly for devices that address unmet needs. Previous policies have focused on emergency public health incidents and innovative technology.
Evolving regulatory protocols in China have significantly complicated the process for OEMs wishing to set up shop there, said Harold Sant, VP of operations for FMI, in a recent report outlining risk mitigation for multinational businesses. The Chinese medical device market was worth $34.5 billion last year, according to Sant, and OEMs “cannot afford to lose their share.”