As anyone who has been through a CFDA approval process knows, the technical review by the Center for Medical Device Evaluation (CMDE) or the Center for Drug Evaluation (CDE) for medicines, is not the end of the road. After the technical review is done there’s a further step of reviews and administrative approval by the CFDA which add more time to the whole registration process.
For some submission types that’s about to change.
Just after Christmas, Dec 29, 2016 China CFDA announced a draft policy change (Mandarin) [link to English translation] which will allow for direct approval of some types of submissions by CDE or CMDE without further review. The types of submissions in scope are listed below:
- China clinical trial approval for local or imported drug
- Supplement approval of local or imported drug
- Re-registration ( license renewal ) of imported drug
- China clinical trial approval for high risk Class III device, local or imported
- Approval of technical change of local Class III device and any imported device
- Re-registration ( license renewal ) of local Class III device and any imported device
Under current procedures, after the technical review process is finished by CDE or CMDE, these submissions are forwarded to CFDA for administrative approving and license issuing. The new policy will allow the CMDE or CDE to issue the approval directly – shaving a month or more from approval times. .
This is a a further step forward CFDA’s continuing efficiency drive in regulation of drugs and medical devices. The new policy is planned to be formally put into effect on July 1, 2017. CFDA is seeking comments before February 6.
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