DMF介绍-英文.ppt

* DMF Retirement Procedure FDA sends overdue notice letter (ONL) to holder and/or agent using most recent address. If no response in 90 days, one copy of DMF is sent to Federal Records Center (FRC) and the other is destroyed. / 45 * Changes in DMF System Over the past decade, there have been some changes in the DMF system to help make it work better. However some things remain the same. / 45 * Changes in the DMF System andProcedures (Internal) Creation of Review Cover Form Creation of Type II Review Format Implementation of Re-review Policy Creation of Central Review File Revision of Database View / 45 * Changes in the DMF System andProcedures (External) Elimination of Type I DMFs Post-Approval Changes Guidance and Creation of DMF List Website Creation of DMFQUESTION Establish Position of DMF Expert / 45 * UNCHANGED THINGS OF DMF No review of DMFon receipt of it. Review only when referenced in application. All of the DMF is still confidential. DMFs are neither approved nor disapproved. The holder still has the responsibility to notify customer of changes. / 45 * Summary The DMF system presents challenges for both the industry and the FDA. Some of the changes have made the system smoother (hopefully for both industry and FDA). Problems can be minimized: – With full understanding of their responsibilities and adherence to Guidances on the part of holders and applicants. – With adherence to policies and procedures on the part of reviewers. / 45 * THIS WAS ALL ABOUT WHAT USFDA SAYS ABOUT DMF. / 45 * NOW,…What European Drug Master File Procedure for Active Substances says about the DMF… CONTENT OF DRUG MASTER FILE APPLICANT’S PART OF DMF ASM RESTRICTED PART OF DMF 2 PARTS OPEN PART CLOSED PART / 45 * APPLICANT’S PART OF DMF OPEN PART( AVAILABLE TO APPLICANT) ACTIVE SUBSTANCE MANUFACTURER SUPPLIES INFORMATION TO THE APPLICANT THIS INFORMATION INCLUDES: outline of the manufacturing method impurities originati