State Food and Drug Administration, Provisions for the Administration of Special Examination and Approval for the Registration of New Pharmaceuticals

国家食品药品监督管理局新药注册特殊审批管理规定

February 09, 2009 | BY

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Priority given to registration of novel pharmaceuticals.

Clp Reference: 1740/09.01.07 Promulgated: 2009-01-07 Effective: 2009-01-07

Promulgated: January 7 2009
Effective: as of date of promulgation

Main Contents: The State Food and Drug Administration shall implement special examination and approval procedures for the application for registration of new pharmaceuticals that are:

(1) effective ingredients extracted from materials such as plants, animals and minerals, and the medicinal preparations made therefrom, that are not yet sold on the China market, and newly-discovered medicinal materials and the medicinal preparations made therefrom;

(2) chemical raw materials for pharmaceuticals and the medicinal preparations made therefrom, and biological products that are not yet approved for sale on the China and overseas markets;

(3) new pharmaceuticals that have a marked edge in clinical treatment of AIDS, malignant tumours and rare diseases; and

(4) new pharmaceuticals for treating diseases for which there is no effective treatment at the moment (Article 2).

The State Food and Drug Administration shall, in the course of registration, give priority to the applications for registration and enhance communication with the applicants if, upon examination, the applications are confirmed to fall under the aforementioned circumstances (Article 3).

Related Legislation: Measures for the Administration of the Registration of Pharmaceuticals, Jul 10 2007

clp reference:1740/09.01.07promulgated:2009-01-07effective:2009-01-07

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