Medical network - on December 16
A, the domestic sale agents to increase has been approved by what to declare new indications in a foreign country?
"In domestic market sales agents to increase has been approved by the foreign new indications" relevant application matters, but under the current "drug registration management method" in annex 4 country approval to the supplement items to declare item 3.
Second, the domestic sale agents at home and abroad has not been approved new indications by what to declare?
According to the classification of new registered 2.4 to declare.
Three, the classification of the chemical new registered 2.4 known the meaning of the active ingredient in class?
Active ingredients known refers to "active ingredients of drugs already on the market," includes domestic listed overseas.
Four, the new registration category 3, 4 class, how to apply for registration?
Production form to apply for registration in accordance with the declaration.
Five, the classification of the new registered on import chemicals 5 class how to charge?
(a) new registered classification of five types of drugs registration fee in accordance with the imported without clinical trial production/listed, need to production/listed registration fee standard rate of clinical trials. Application of clinical trial registration fee is 367600 yuan, after finishing the clinical trials for production/listed need to pay the difference of 134400 yuan. Application without clinical trial production/listed registration fee is 367600 yuan, after the technical evaluation need to need to pay the difference of clinical trials of 134400 yuan. Application to clinical trial production/listed registration fee is RMB 502000.
(2) the classification of new registered five types of drug clinical trials are applying to be reduced or exempted in accordance with the approved clinical trial, declaration of production/listed need to pay 67200 yuan.
