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为保证人民用药安全有效,卫生部曾颁布了《进口药品管理办法》,明确规定,国家对进口药品实行注册制度,申请进口药品的单位,须经卫生部批准发给《进口药品注册证》;未取得《进口药品注册证》的,须经卫生部批准发给《一次性进口药品批件》;进口药品须经卫生部授权的口岸药品检验所检验合格后方可进口、销售、使用。
In order to ensure people’s medication is safe and effective, the Ministry of Health has promulgated the Measures for the Administration of Imported Drugs, which clearly stipulates that the state shall implement a registration system for imported drugs. Units that apply for import of drugs must obtain the Import Drug Registration Certificate upon approval by the Ministry of Health. If the imported drug registration certificate is not obtained, it must be approved by the Ministry of Health to issue the “one-time imported drug approval document.” The imported drug product must be inspected and approved by the port drug inspection agency authorized by the Ministry of Health before being imported, sold and used.