5 Post Approval Changes for Finished Product.ppt

AAPS/CPA Workshop, June 28-29, 2010 Post Approval Changes for Finished Product Lin Hong Disclaimer The information contained in the presentation has been compiled from various sources. The views and opinions expressed are those of the individual presenter and should not be attributed to any organization with which the presenter is employed or affiliated. Post Approval Changes Guideline Documents US: SUPAC: IR (1995), MR (1997) SUPAC: IR/MR Equipment Guidance (1999) SUPAC: Extended release Oral Solid Dosage Forms, Development, Evaluation and Application of In-Vitro/In-Vivo Correlation (1997) Changes to an Approved NDA or ANDA (2004) Post Approval Changes Guideline Documents EU: Commission Regulation (EC) No 726/2004 Commission Regulation (EC) No 1234/2008 Commission Regulation (EC) No 1084(5)/2003 Modified Release Oral and Transdermal Dosage Forms: Sections I and II CPMP/QWP/604/96, CPMP/EWP/280/96 Guideline on the Investigation of Bioequivalence CPMP/EWP/QWP/1401/98 United States The guidelines provide details of the … Type of change Levels of change CMC documentation required to support the change (dissolution and /or bioequivalence tests, analytical testing….) Filing requirements United States Minor Change (Level 1): Minimal potential to have an adverse effect Annual report (AR) Moderate Change (Level 2): Moderate potential to have an adverse effect Changes Being Effected (CBE) Changes Being Effected 30 days (CBE-30) Major Change (Level 3): Substantial potential to have an adverse effect Prior Approval Supplement (PAS) United States To Industry: Responsibility to classify change moved from FDA to industry Allows more changes without prior FDA approval Use of new technologies Manufacturing cost reduction Adequacy of the studies may be questioned months or years later even if the changes are predicted or approved If the validity of AR/CBE/CBE-30 changes is challenged the sponsor may be required to track the affected lots/batches and provide additional