Cisema’s regulatory affairs consultant Anna King was recently cited by Bioworld in their article titled “China clarifies rules for registration and classification of drug-device combinations”.
Mrs King and Stephen Sunderland from LEK Consulting LLC gave their views on the recent clarification from NMPA regarding drug-device combination products.
“Before the new regulation, a manufacturer had to try their luck and decide themselves whether they should submit their application to the technical review body for drugs CDE or the technical review body for medical device CMDE,” said King.
“With the new regulation, the procedure and responsibility are very clear now,” she said.
We have published more about the recent NMPA announcement in our blog post “New Preconditions for Marketing Approvals of Combination Products in China”.
Contact Cisema if you would like to learn more.