On 01.07.2019, the 2018 Drug Review Annual Report was released. Of the grand sum of 9,796 registration applications reviewed and approved in 2018, 7,988 were subject to technical review and 1,808 to direct administrative approval.
On 14.08.2018, the SAMR defined the 8th batch of Drug – Medical Device Combination Products in their announcement No. 218-2018. When applicants are unsure, whether a product is categorized as a medical device or drug, a classification application can be submitted to the SAMR for verification.