In March, along with other business such as extending lifetime tenure to the Chinese President, the 13th National People’s Congress approved the Institutional Reform Plan of the State Council (here in English for those enthusiastic followers of all things China). This plan brought about a merger of a host of current regulatory agencies – including CFDA, into a new super-ministry for all things regulatory.
First a new acronym, the SMRA – or the State Market Regulatory Administration. This new ministry will be ranked as a Directly Subordinate Agency – the same rank as the current CFDA.
In addition to CFDA’s current roles, the SMRA will also take on direct powers for standards setting, laboratory accreditation and policy direction (unlike CFDA which currently drafts and then implements powers and policies decided at Ministry level). Added to the existing Food, Drug and device regulation, SMRA will have responsibility for company registrations, consumer protection and advertising and anticorruption enforcement currently exercised by the State Administration for Industry and Commerce (SAIC).
The new reorganisation includes set up of a separate and distinct drug regulation division the State Drug Administration (echoes of the old SPAC: State Pharmaceutical Administration of China?). But it’s not yet clear how this will affect day to day regulation of medical devices and IVDs.
The biggest unknown is how (or even if) the new agency will continue with the ongoing reforms to the devices regulations, especially the draft revision of Order 650 and the ongoing Innovative Device and Priority review pathways.. The order 650 went back to State Council in March for review, some of the enabling provisions are not due to be delivered to State Council until August.
With the upheaval of setting up the new SMRA, don’t expect things to go too quickly. Watch this space for further updates.
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