REGULATORY INFORMATION
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| Initial evaluation | RFI #1 response time | Evaluation of additional information 1 | RFI #2 response time | Evaluation of additional information 2 | |
|---|---|---|---|---|---|
| NMAs | To be completed by Medsafe within 200 calendar days | The applicant's response is required within 200 calendar days | To be completed by Medsafe within 120 calendar days | The applicant's response is required within 120 calendar days | To be completed by Medsafe within 120 calendar days |
| CMNs (not CMN 24.5) |
To be completed by Medsafe within 45 calendar days | The applicant's response is required within 21 calendar days | To be completed by Medsafe within 45 calendar days* | ** |
*Please note that CMNs are referred to the Minister under section 24 (5) of
the Medicines Act 1981 if they are not resolved within 90 days of receipt of
payment.
**There is no limit to the number of RFIs issued during the 90 day period, as
long as all issues are resolved within 90 days of receipt of payment.
Medsafe's target is to complete the initial evaluation of all New Medicine Applications (NMAs) within 200 calendar days of the receipt of payment. During this period the status column of the application in the application search will indicate 'initial evaluation'. The first phase of the initial evaluation involves an overall review of the entire application. If any information is missing or deficient, the evaluation is halted and a request for the omitted data is made. Applicants are given 10 days to supply the requested information. The initial evaluation is then completed. The outcome of the initial evaluation usually results in a Request for Information (RFI).
Applicants are given 200 calendar days to submit their response to an RFI. During this period, the status of the application will indicate 'information requested'.
The evaluation of the response to any RFI will be completed within 120 calendar days of receipt. During the evaluation of the response to an RFI, the status of the application will indicate 'additional evaluation'.
When the status of the application under the application search indicates 'peer review', this means that the draft evaluation is being reviewed by a senior evaluator. This occurs following both an initial evaluation, and evaluation of additional information.
Once the evaluation has been finalised and the product has either been forwarded for the gazettal process or referred for the next MAAC meeting, the status of the application will indicate 'evaluation complete'. Once the product has been gazetted, the status will read 'granted' with the date of gazettal underneath.
When applications accepted for priority assessment are allocated to an evaluator, it is assigned as their next piece of work to be completed. The evaluation of responses to RFIs for priority assessments are treated the same way. The speed at which an evaluation is completed depends on the complexity of the dossier, the quality of the dossier, and the total number of priority assessments received during any particular month.
The initial evaluation of all Changed Medicine Notifications (CMNs) will be completed within 45 calendar days of the receipt of payment. During this period the status column of the application will indicate 'initial evaluation'.
Applicants are given 21 calendar days to submit their response to an RFI. During this period, the application status will be 'Information requested'.
Medsafe will complete the evaluation of the response to an RFI for a CMN within 45 calendar days. During this period the application status will read 'additional evaluation'.
If any concerns that have arisen during the evaluation of a CMN have not been resolved within 90 days, it will be referred under Section 24 (5)b of the Medicines Act 1981 to undergo evaluation according to the NMA timeframe. This occurs regardless of whether the CMN resides with Medsafe or the applicant.
Please note that the progress of applications from the point of assignment will depend on a number of factors, such as the number and complexity of applications with a common application date. Please remember that the workload of individual evaluators does vary so it is possible that the initial evaluation reports may not be issued in chronological order.
Although the timelines referred to above indicate Medsafe's intentions, occasionally an application may exceed the target time due to its complexity, and/or need to solicit independent expert advice.
Medsafe requests that companies do not seek more specific information concerning queue status. Researching these queries takes evaluators away from their technical assessments.