For an overseas applicant, its work office stationed in China or an agency within China commissioned by it shall make the drug registration for it. 境外申請人辦理進(jìn)口藥品注冊，應當由其駐中國境內的辦事機構或者由其委托的中國境內代理機構辦理。
Application for drugs with existing state standards shall refer to the application for registration of the drugs for which the SDA has promulgated official standards. 已有國家標準藥品的申請，是指生產(chǎn)已經(jīng)由國家藥品監督管理局頒布的正式標準的藥品注冊申請。
