Last month, the China Food and Drug Administration (CFDA) published drafts of four proposed policies in the form of circulars (or notices) for public comment. These proposed policies include significant reforms in the areas of the new drug and device approval process (“Circular 52”), clinical trial regulation (“Circular 53”), life-cycle management and post-marketing surveillance (“Circular 54”), and regulatory data protection and patent linkage (“Circular 55”).
These proposed policies signal important changes for medical devices. For example, the proposed policies would expressly permit imported devices applications to rely on data generated by trials in other countries, provided that the trial meets CFDA requirements and has undergone a site inspection. CFDA does not currently have a general policy on when it will accept foreign data. The proposed policies do not specify further details on these requirements and site inspections.
The proposed policies also indicate that the current marketing authorization holder pilot program for drugs could be expanded to medical devices. The pilot program allows for certain smaller research-based institutions and individuals in select provinces to own drug registration licenses without having a manufacturing facility. In contrast, except for certain innovative devices, a domestic applicant for a device license must have a facility that is compliant with device good manufacturing practice and that has a manufacturing license issued by the provincial food and drug regulatory authority.
The proposed policies contain a number of reforms in other areas. Our client alert with more information about each of the four proposed policies is available here. The deadline for comments is June 10, 2017.