11 October 2017
| Application type | Received |
|---|---|
| Higher risk medicine | 48 (50% abbreviated) |
| Intermediate risk medicine | 73 (70% abbreviated) |
| Lower risk medicine | 23 |
| Changed medicine | 1392 |
| Priority assessment | 8 |
| Application type | Consented |
|---|---|
| Higher risk medicine | 48 |
| Intermediate risk medicine | 79 |
| Lower risk medicine | 24 |
| Changed medicine | 1378 |
| Referred | 80 (6%) |
|---|---|
| Consented | 74 |
The number of applications received is different to the number of consents
granted because the approval process may be longer than 12 months. Applications
consented in any given year typically include a proportion lodged in preceding
years.
Number of administrative events completed within Medsafe's target processing times (in calendar days).
| Application Type/Event | Initial evaluation | 1st Request for information | Evaluation of 1st response | 2nd Request for information | Evaluation of 2nd response |
|---|---|---|---|---|---|
| Higher risk medicine application (full evaluation) | 58% (19 of 33) within 200 days 80% within 262 days |
94% within 200 days | 48% within 120 days | 93% within 120 days | 58% within 120 days |
| Higher risk medicine application (abbreviated evaluation) | 38% (12 of 32) within 100 days 90% within 200 days |
||||
| Intermediate risk medicine application (full evaluation) | 65% (24 of 37) within 200 days 80% within 231 days |
91% within 200 days | 56% within 120 days | 89% within 120 days | 55% within 120 days |
| Intermediate risk medicine application (abbreviated evaluation) | 62% (23 of 37) within 100 days 90% within 154 days |
||||
| Lower risk medicine application | 88% (30 of 34) within 200 days | 96% within 200 days | 93% within 120 days | 100% within 120 days | 77% within 120 days |
| Initial evaluation | Requests for information | Evaluation of responses | |
|---|---|---|---|
| Changed medicine notifications | 95% (1335 of 1409) within 21 days | 65% within 21 days | 93% within 21 days |
| Application type/Event | Initial evaluation | 1st Request for information | Evaluation of 1st response | 2nd Request for information | Evaluation of 2nd response |
|---|---|---|---|---|---|
| N1 15% of applications |
60% (3 of 5) within 30 days 80% within 40 days |
75% within 7 days | 25% within 7 days 80% within 24 days |
50% within 7 days | 0% within 21 days 100% within 38 days |
| N3 56% of applications |
16% (3 of 19) within 60 days 80% within 128 days |
31% within 30 days | 50% within 30 days 80% within 35 days |
50% within 30 days | 40% within 30 days 80% within 57 days |
| N4 5% of applications |
0% (0 of 2) within 90 days 100% within 117 days |
0% within 30 days | None completed in 2016 | None completed in 2016 | 0% within 30 days 100% within 140 days |
| N5 24% of applications |
25% (2 of 8) within 120 days 80% within 229 days |
11% within 60 days | 38% within 60 days 80% within 108 days |
90% within 60 days | 0% within 60 days 80% within 121 days |
The following table represents the total time to conclude the stated proportion of applications in calendar days. Total time is calculated from the date of payment to the completion of evaluation and includes the time taken by the applicant to respond to any requests for information.
| Proportion of applications concluded within specified time in calendar days | ||||
|---|---|---|---|---|
| Application Type | Mean | 70% | 80% | 90% |
| Higher risk medicine via full evaluation | 388 | 435 | 514 | 605 |
| Higher risk medicine via abbreviated evaluation | 373 | 454 | 489 | 556 |
| Intermediate risk medicine via full evaluation | 670 | 734 | 858 | 1011 |
| Intermediate risk medicine via abbreviated evaluation | 459 | 504 | 653 | 961 |
| Priority assessment via full evaluation | 338 | 329 | 329 | 403 |
| Priority assessment via abbreviated evaluation | 148 | 154 | 156 | 216 |
The following table represents the number of calendar days that Medsafe spent on evaluating various application types.
| Proportion of applications concluded within specified time in regulator calendar days | |||
|---|---|---|---|
| Application Type | Mean | 80% | 90% |
| Higher risk medicine via full evaluation | 306 | 433 | 440 |
| Higher risk medicine via abbreviated evaluation | 281 | 354 | 423 |
| Intermediate risk medicine via full evaluation | 473 | 596 | 653 |
| Intermediate risk medicine via abbreviated evaluation | 294 | 395 | 446 |
| Priority assessment via full evaluation | 258 | 268 | 280 |
| Priority assessment via abbreviated evaluation | 120 | 126 | 184 |
The following table represents the total time to conclude the stated proportion of applications in calendar days.
Total time is calculated from the date of payment to the completion of evaluation and includes the time taken by the applicant to respond to any requests for information.
| Proportion of applications concluded within specified time in calendar days | ||||
|---|---|---|---|---|
| Application Type | Mean | 70% | 80% | 90% |
| N1 | 107 | 118 | 118 | 126 |
| N3 | 342 | 400 | 415 | 447 |
| N4 | 396 | 349 | 349 | 489 |
| N5 | 559 | 584 | 622 | 727 |
| Application type | 2013 | 2014 | 2015 | 2016 |
|---|---|---|---|---|
| Higher risk medicine | 49 (57% abbreviated) | 56 (70% abbreviated) | 60 (60% abbreviated) | 48 (50% abbreviated) |
| Intermediate risk medicine | 109 (62% abbreviated) | 83 (60% abbreviated) | 75 (50% abbreviated) | 73 (70% abbreviated) |
| Lower risk medicine | 63 | 58 | 50 | 23 |
| Changed medicine | 1369 | 1525 | 1415 | 1392 |
| Priority assessment | 4 | 12 | 10 | 8 |
The following graph represents the total time to conclude the stated proportion of applications in calendar days inclusive of applicant response time.
The following graph represents the regulator time to conclude the stated proportion of applications in calendar days exclusive of applicant response time.
Performance against evaluation timeframes 2015
Performance against evaluation timeframes 2014
Performance against evaluation timeframes 2013
