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一、国外药品在中国进行临床试验,必须按照中华人民共和国卫生部《关于国外药品在中国注册及临床试验的规定》,由国外厂商向卫生部药政局提出书面申请,经批准后方可进行.二、申请进行药品临床试验时,申请者必须说明该项研究的目的,并提供以下资料:1.该药品在申请者所在国或他国(地区)注册或获准进行临床试验的证明文件.2.关于生产该药品的厂家符合药品生产质
First, the foreign drugs in clinical trials in China, must be in accordance with the People’s Republic of China Ministry of Health, “on the foreign drug registration and clinical trials in China,” by foreign manufacturers to the Ministry of Health Pharmaceutical Council submitted a written application, after approval. , When applying for the clinical trial of the drug, the applicant must explain the purpose of the study and provide the following information: 1. The drug is registered in the applicant’s country or other country (region) or is allowed to carry out clinical trials. 2. About The manufacturer of the drug is in line with the quality of the drug