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Jan 2014

270 days. 270 days. 270 days. 270 days. 270 days. ?. 270 days*. 90 or 270 days*. 270 days*. 270 days*. Jan 2014. Traditional TS or ANADA. Jan 2014. Phased TS – MF reference (new MF) and/or analytical method validations. Jan 2014.

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Jan 2014

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  1. 270 days 270 days 270 days 270 days 270 days ? 270 days* 90 or 270 days* 270 days* 270 days* Jan 2014 Traditional TS or ANADA Jan 2014 Phased TS – MF reference (new MF) and/or analytical method validations Jan 2014 Parallel phased TS – MF reference (new MF) and/or analytical method validations ANADA/TS/phased TS Response to incomplete comments, if applicable GMP status check Review of MF and/or submission *Possible option for 90 or 270 days review timeline

  2. 270 days ANADA/TS Response to incomplete comments, if applicable GMP status check Review of master file (MF)/submission 270 days* Jan 2014 Traditional TS or ANADA • Time to approval: 270 days + 0/90/270 days, depending on the nature of the comments (270 days typical). • GMP status check upon receipt of TS, inspections are issued when necessary. • Review of the submission and any master files begins several months prior to the due date. • Any incomplete comments for the TS and MF will be reviewed during the reactivation • The amount of time between submissions is a business decision on the part of the sponsor. • This process may work best for established and frequently referenced master files and facilities with an acceptable cGMP status. • If a new master file/other complicated data is submitted, the risk of a second cycle of review at the full review timeframe (270 days) increases. *Possible option for 90 or 270 days review timeline

  3. 270 days 270 days ANADA/TS/phased TS Response to incomplete comments, if applicable GMP status check Review of MF and/or submission 90 or 270 days* *Possible option for 90 or 270 days review timeline Jan 2014 Phased TS – MF reference (new MF) and/or analytical method validations • Time to approval: 270 days (from Jan 2014) + 0/90/270 days, depending on the nature of the comments (0 or 90 days may be more likely for this option). • GMP status check upon receipt of each phase, inspections are issued when necessary. • Review of the submission and any master files occurs concurrently. • Responses to incomplete comments from phase I will be included in phase II. There may also be incomplete comments in phase II regarding information provided in phase I, where relevant. • This process may work best for new or not frequently referenced master files or facilities that have not been recently inspected. Submission of an early phase allows additional time for scheduling inspections of facilities and addressing incomplete comments in master files. • Allows for early review of items that are likely to result in incomplete items and reduces the risk of a second cycle review at the full review timeframe (270 days). • Requires planning on the part of the sponsor, and submission of initial phase early enough so that the overall time to approval is not affected.

  4. Jan 2014 270 days 270 days ANADA/TS/phased TS Response to incomplete comments, if applicable GMP status check Review of MF and/or submission 270 days* 270 days* Parallel phased TS – MF reference (new MF) and/or analytical method validations • Time to approval: 270 days (from Jan 2014) + 0/90/270 days + Additional Time Due to Multiple Reactivations/Issues from early phase not being addressed in later phase; or if no reactivation of phase II then 270 (from Jan 2014) + whatever time is left on the phase I reactivation (90/270 days) • GMP status check upon receipt of each phase, inspections are issued when necessary. • Review of the submission and any master files occurs concurrently. • If there is an incomplete comment on a Master File in the early phase, there may not be enough time for the Master File holder to get their response in before we begin review of the later phase, so the incomplete comment may continue through both phases, resulting a longer reactivation time line. • Any incomplete comments from phase I will be addressed in a first reactivation. There may also be incomplete comments in phase II regarding information provided in the early phase. This process could be particularly complicated if the early submission contains a reference to a Type V master file or sterile validation information. • This process is less ideal from DMT’s perspective due to the potential for overlapping comments in multiple open submissions. For parallel reactivations with multiple overlapping comments, it may be necessary to reset the clock on the phase I reactivation to coincide with the later phase II timeline so that the information can be reviewed concurrently. • This process may work for phase I submissions that contain only established and frequently referenced Type II master files. *Possible option for 90 or 270 days review timeline

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