如何申报新药（How to declare new drugs）.docVIP

如何申报新药（How to declare new drugs） How to declare new drugs? 1, the state and Provincial Drug Administration approval duties: the State Administration of drug supervision in charge of drug registration throughout the country. State Drug Administration of drug registration department (hereinafter referred to as the drug registration department) on behalf of the State Drug Administration accepted the application for drug registration, issued by the review tasks, drug registration is approved, apply for certification, and the implementation of the supervision and management of drug registration. The drug supervision and administration departments of the provinces, autonomous regions and municipalities directly under the central government shall accept the applications for new drugs and generic drugs within the jurisdiction, and shall complete the preliminary examination work in accordance with the provisions (except as otherwise stipulated by the state). 2, technical review responsibilities: the State Drug Administration Center for drug evaluation (hereinafter called 100038) is the State Drug Administration of drug registration technical evaluation agency, the Department of drug registration under the leadership of new drugs and imported drugs, generic drugs and technology review work, put forward comprehensive evaluation opinions, reported to the Department of drug registration audit. The drug review experts of the State Drug Administration shall be responsible for the formulation of new drugs (including new biological products), technical review and consultation opinions on imported drugs and generic drugs. The review will be convened by the National Drug Administration from a random selection of experts from the national drug review expert library. The China National Institute for drug and biological products is responsible for laboratory technical review of new drugs and biological products. The provincial drug inspection office is responsible for the laboratory tech