申报新药的步骤（Steps to declare new drugs）.docVIP

申报新药的步骤（Steps to declare new drugs） The step of declaring a new drug.Txt when he was young, he took many pictures and placed them in the living room for others to see. When he was old, he realized the photos were taken for his own eyes. When most people are concerned about whether you fly high or not, only a small number of people care about you, and you are tired and tired. That is friendship! How to declare new medicine 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.