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Technical Guidelines for Research Changes of Chemical Drugs on the Market (first)
Request Technical Guidelines for Research Changes of Chemical Drugs on the Market (first)
  • Local Title:已上市化学药品变更研究的技术指导原则（一）
  • Country/Region:Chinese Mainland
  • Competent Authority: Former China Food and Drug Administration (CFDA)
  • Type:Guideline
  • Status:In force
  • Release Date:2008-05-15
  • Implementation Date:2008-05-15
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ZH Official 已上市化学药品变更研究的技术指导原则（一） Download
Summary

The Technical Guidelines for  Research Changes of Chemical Drugs on the Market (first) was issued on May.15, 2008. It gives technical guidelines for research changes of chemical drugs in China, which includes:

1. Overview

2. Basic Principles

3. Changes of Manufacturing Process of Pharmaceutical Raw materials

4. Changes of Auxiliary Material

5. Processing Technique of Chemical Formulations

6. Standards of Changed Chemical Drugs and the Packaging Standards

7. Registration Standards of Changed Chemical Drugs

8. The Period of Validity and the Storage Codition of Changed Chemical Drugs

9. The Packaging Material and Containers of Changed Chemical Drugs

10. New Source of Imported Chemical Formulations

11. Changes of Origins

12. Changes of the Origin of Raw Materail 

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