New Investivational Drug Application

Abstract

Similar to western countries, investigational new drug (IND) application and new drug application (NDA) are the essential processes needed for marketing a drug in China. For local or multinational pharmaceutical companies with manufacturing facilities in China, the application pathways and processes are different from those of import drug applications of overseas pharmaceutical companies. For the application of import drugs, the candidate drug has to have entered phase II or III clinical stage overseas as a basic prerequisite (SFDA, Provisions for drug registration, No. 28. June 18, 2007 http://eng.sfda.gov.cn/WS03/CL0768/61647.html, 2007). Sponsors can submit the dossiers directly to China Food and Drug Administration (CFDA) and do not need to go through the provincial-level FDA approval process as local pharmaceutical companies must. For the import drug application, sponsors should also be advised to take advantage of CFDA regulations regarding special review and approval qualifications (SFDA, Special review and approval procedure for drug registration of the State Food and Drug Administration. SFDA Decree No. 21; Effective on Nov. 18, 2005, Regulations of special examination and approval in new drug registration. Issued by SFDA on January 7, 2009 http://wenku.baidu.com/link?url=uxkOSjVhDzHri_ODNd5ptqE8j4lBfDABoZLEPXiNrDxLFV3wRC58LDRvnNwBq9EvE1uGdSSmS8WNJSLu4Gog, 2009). In this chapter, we’ll focus on import drug applications. In addition, supplementary applications, import drug repackaging applications, special drug category applications, and approvals will be introduced.