Brandwood Biomedical, our Asia Pacific strategic partner, reported this week in a blog post that the China Food and Drug Administration (CFDA) aims to speed up regulatory reviews. The draft policy change, released on December 29, 2016, will impact submissions for drugs and medical devices. The policy change will allow for certain types of drug and medical device submissions to receive direct approval by the Center for Drug Evaluation (CDE) or Center for Medical Device Evaluation (CMDE) without further review.
To learn more about the types of submissions within the scope of the new draft policy, please visit the Brandwood Biomedical blog post here. If your company plans to enter the Chinese market with your product, please contact the expert bilingual team at Brandwood Biomedical for help with your Chinese regulatory and clinical needs. For US / FDA regulatory support, please contact our staff at Pearl Pathways.