... Drug Inspection Laboratory 药品检查实验室(美国FDA下属机构) Drug Manufacturing License 药品生产许可证 Drug Master File (DMF) 药物主文件 ...
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药品生产许可证》应当标明有效期和生产范围。
The term of validation and the scope of manufacturing shall be noted in the Drug Manufacturing Certificate.
情节严重的,吊销药品生产许可证、药品经营许可证或者医疗机构执业许可证书。
If the circumstances are serious, the Drug Manufacturing Certificate, Drug Distribution Certificate, or the license for the medical institution shall be revoked.
负责药品生产许可证的申领工作,新品的国内和国际注册工作及GMP认证工作。
In charge of application of drug production permit and domestic and international registration, and GMP certification of new API.
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