Guiding Principles for the Registration and Inspection of Imported Drugs

Local Title:进口药品注册检验指导原则
Country/Region:Chinese Mainland
Competent Authority: Former China Food and Drug Administration (CFDA)
Type:Guideline
Status:In force
Release Date:2004-06-25
Implementation Date:2004-06-25

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ZH	Official	进口药品注册检验指导原则	Download

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进口药品注册检验指导原则

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The Guiding Principles for the Registration and Inspection of Imported Drugs was issued on Jun. 25, 2004. It is formulated in order to strengthen the registration management of imported drugs and ensure the standardization of the registration and inspection of imported drugs, which includes

1. Procedure and Time Limit for Registration and Inspection of Imported Drugs

2. Principle of Quality Standards Review

3. Writing Requirements of Review Standards

4. Requirements for Writing Drafting Instructions

5. Other Requirements