常用藥品監管英語及其縮略語(doc 39頁)

常用藥品監管英語及其縮略語目錄：
一、監管英語
二、常用英文縮寫

常用藥品監管英語及其縮略語內容提要：
省、自治區、直轄市人民政府藥品監督管理部門負責本行政區域內的藥品監督管理工作。
The drug regulatory agencies of the governments of provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for drug regulation in their administrative areas.
藥品監督管理部門設置或者確定的藥品檢驗機構，承擔依法實施藥品審批和藥品質量監督檢查所需的藥品檢驗工作。
The drug quality control laboratories established or designated by drug regulatory agencies shall undertake the responsibility for drug testing required for conducting drug review and approval and controlling drug quality pursuant to the law.
開辦藥品生產企業，須經企業所在地省、自治區、直轄市人民政府藥品監督管理部門批準並發給《藥品生產許可證》，憑《藥品生產許可證》到工商行政管理部門辦理登記注冊。
Any newly established pharmaceutical manufacturer shall be subject to approval by the local drug regulatory agency of the government of the province, autonomous region or municipality directly under the Central Government and be granted the Drug Manufacturing Certificate, and, with the certificate, the manufacturer shall be registered with the administrative agency for industry and commerce.

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