已上市化学药品变更研究探究 的技术指导原则英文版.docxVIP

GUIDELINE No.: H G B ( 1 ) T - 1 Technical Guideline for Making Post Approval Changes to Chemical Drug Products (I) 1 April 2008 2 Table of contents HYPERLINK \l bookmark1 \o Current Document Overview 2 HYPERLINK \l bookmark2 \o Current Document Basic principles for performing studies post-approval changes to chemical drug products 3 HYPERLINK \l bookmark3 \o Current Document Changes to Drug Substance Manufacturing Process 6 Changes to excipients in a drug formulation 14 Changes to the manufacturing process for a drug product 22 HYPERLINK \l bookmark6 \o Current Document Changes to drug product strength and packaging size 30 Change to drug prodcugt specificication 36 HYPERLINK \l bookmark8 \o Current Document Changes to the drug prodcut shelf-life (expiration dating period) and/or storage conditions 41 Changes to drug product packaging materials and the container closure syatem ... 37 HYPERLINK \l bookmark10 \o Current Document Changes to the manufacturing site of an imported drug product 51 HYPERLINK \l bookmark11 \o Current Document Change to the manufacturing site of API used in an imported drug product and change to the manufacturing site of an imported API 48 Changes in the site of Manufacture for API used in a domestic drug product..... Error! Bookmark not defined. HYPERLINK \l bookmark13 \o Current Document Appendix I Basic methods for comparison investigation of drug dissolution/release 36 Appendix II General considerations for exemption of in vivo bioequivalence (BE waiver) 72 Appendix III A partial list of of medicines with narrow therapeutic windows Error! Bookmark not defined. HYPERLINK \l bookmark16 \o Current Document References 77 HYPERLINK \l bookmark17 \o Current Document Glossary 79 Authors 80 1 I. Overview This guideline is primarily used to guide pharmaceutical manufacturers to carry out studies for post-approval changes (or changes) to chemical drug products. Changes here refer to the changes that involve source, methods, control cond