Published: 4 March 2016
Medicines
Medsafe’s performance in the evaluation of new and changed medicines during 2015
Total number of applications received – 1 January to 31 December 2015
| Application type | Received |
|---|---|
| Higher risk medicine | 60 (60% abbreviated) |
| Intermediate risk medicine | 75 (50% abbreviated) |
| Lower risk medicine | 50 |
| Changed medicine | 1415 |
| Priority assessment | 10 |
Total number of applications granted consent – 1 January to 31 December 2015
| Application type | Consented |
|---|---|
| Higher risk medicine | 50 |
| Intermediate risk medicine | 61 |
| Lower risk medicine | 34 |
| Changed medicine | 1368 |
| S24(5) referrals | 67 (5%) |
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.
Recorded performance
Key Performance Indicators
- 85% of new medicine applications had an initial assessment completed within 200 calendar days
- 100% of changed medicine notifications were responded to within 45 calendar days
Target Processing Times
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 applications via full evaluation |
40% (8 of 20) within 200 days 80% within 267 days |
100% within 200 days | 72% within 120 days | 85% of within 120 days | 76% within 120 days |
| Higher risk medicine applications via abbreviated evaluation |
60% (17 of 28) within 100 days 90% (25 of 28) within 120 days |
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| Intermediate risk medicine applications via full evaluation |
30% (10 of 32) within 200 days 80% within 220 days |
86% within 200 days | 62% within 120 days | 83% within 120 days | 70% within 120 days |
| Intermediate risk medicine applications via abbreviated evaluation |
80% (31 of 38) within 100 days |
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| Lower risk medicine applications |
95% (38 of 40) within 200 days |
91% within 200 days | 100% within 120 days | 96% within 120 days | 87% within 120 days |
| Application Type/ Event | Initial evaluation | Requests for information | Evaluation responses |
|---|---|---|---|
| Changed medicine notifications | 92% (1279 of 1389) within 21 days | 63% within 21 days | 99% within 30 days |
| Lower risk medicine applications submitted via new business processes | |||||
|---|---|---|---|---|---|
| Application Type/Event | Initial evaluation | 1st Request for information | Evaluation of 1st response | 2nd Request for information | Evaluation of 2nd response |
| N1 54% of applications |
26% (5 of 19) within 30 days 80% within 44 days |
18% within 7 days | 12% within 7 days 80% within 27 days |
80% within 7 days | 80% within 21 days |
| N3 26% of applications |
44% (4 of 9) within 60 days 80% within 72 days |
11% within 30 days | 38% within 30 days 80% within 42 days |
25% within 30 days | 63% within 30 days 80% within 45 days |
| N4 9% of applications |
33% (1 of 3) within 90 days 80% within 95 days |
0% within 30 days | 100% within 30 days | 100% within 30 days | 50% within 30 days 80% within 39 days |
| N5 11% of applications |
50% (2 of 4) within 120 days 80% within 155 days |
0% within 60 days | 80% within 60 days | 100% within 60 days | 60% within 60 days 80% within 66 days |
Total time to conclude prescription medicine applications (2015)
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 | 467 | 654 | 742 | 783 |
| Higher risk medicine via abbreviated evaluation | 312 | 331 | 408 | 560 |
| Intermediate risk medicine via full evaluation | 604 | 709 | 750 | 824 |
| Intermediate risk medicine via abbreviated evaluation | 407 | 473 | 605 | 694 |
| Priority assessment via full evaluation | 280 | 320 | 324 | 324 |
| Priority assessment via abbreviated evaluation | 158 | 160 | 160 | 174 |
Regulator time taken to conclude applications (2015)
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 | 348 | 464 | 503 |
| Higher risk medicine via abbreviated evaluation | 225 | 275 | 337 |
| Intermediate risk medicine via full evaluation | 406 | 473 | 547 |
| Intermediate risk medicine via abbreviated evaluation | 248 | 311 | 341 |
| Priority assessment via full evaluation | 245 | 295 | 296 |
| Priority assessment via abbreviated evaluation | 130 | 130 | 143 |
Total time to conclude lower risk (OTC) medicine applications submitted via new business rule (2015)
The following table represents the total time to conclude the stated proportion of applications in calendar days. The applications were submitted via the new business rule for OTC medicines implemented in April 2013.
Total time is caluclated 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 | 119 | 143 | 143 | 198 |
| N3 | 356 | 380 | 447 | 497 |
| N4 | 223 | 230 | 230 | 262 |
| N5 | 312 | 321 | 321 | 359 |
Number of applications received during the previous four years
| Application type | 2012 | 2013 | 2014 | 2015 |
|---|---|---|---|---|
| Higher risk medicine | 44 (36% abbreviated) | 49 (57% abbreviated) | 56 (70% abbreviated) | 60 (60% abbreviated) |
| Intermediate risk medicine | 98 (55% abbreviated) | 109 (62% abbreviated) | 83 (60% abbreviated) | 75 (50% abbreviated) |
| Lower risk medicine | 52 | 63 | 58 | 50 |
| Changed medicine | 1457 | 1369 | 1525 | 1415 |
| Priority assessment | 7 | 4 | 12 | 10 |
Comparison of the total time to conclude prescription medicine application during the previous four years
The following graph represents the total time to conclude the stated proportion of applications in calendar days inclusive of applicant response time.
Performance against evaluation timeframes 2014
Performance against evaluation timeframes 2013
