Revised: 27 May 2013
Medicines
Medsafe’s performance in the evaluation of new and changed medicines during 2012
From 1 January to 31 December 2012 the following trends and performance were observed.
Work flows
| Application type | Number of applications | |
|---|---|---|
| Received | Consented | |
| Higher risk medicine | 38 (36% abbreviated) | 35 |
| Intermediate risk medicine | 97 (55% abbreviated) | 74 |
| Lower risk medicine | 52 | 56 |
| Changed medicine | 1457 | 1430 |
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 preceeding
years.
Recorded performance
Number of applications 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 | 9 of 12 (75%) applications completed within 200 days | 83% of applicants responded within 200 days | 95% completed within 200 days | 60% of applicants responded within 120 days | 85% completed within 120 days |
| Higher risk medicine applications via abbreviated evaluation | 16 of 18 applications (89%) completed within 100 days | ||||
| Intermediate risk medicine applications via full evaluation | 24 of 26 applications (92%) completed within 200 days | 82% of applicants responded within 200 days | 96% completed within 120 days | 82% of applicants responded within 120 days | 92% completed within 120 days |
| Intermediate risk medicine applications via abbreviated evaluation | 47 of 48 applications (98%) completed within 100 days | ||||
| Lower risk medicine applications | 39 of 44 applications (88%) completed within 100 days | 80% of applicants responded within 200 days | 96% completed within 120 days | 85% of applicants responded within 120 days | 97% completed within 120 days |
| Application Type/ Event | Initial evaluation | Requests for information | Evaluation responses |
|---|---|---|---|
| Changed medicine notifications | 1415 of 1429 notifications (99%) reviewed within 21 days | Requests for information issued on 20% of notifications
63% of submitters responded within 21 days |
97% reviewed within 21 days |
2% of notifications required referral under s24(5) of the Medicines Act 1981. |
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Time to conclude applications (2012)
| Application type | Mean | 75% | 80% | 90% |
|---|---|---|---|---|
| Higher risk medicine via abbreviated evaluation | 399 | 415 | 415 | 829 |
| Higher risk medicine via full evaluation | 339 | 469 | 522 | 779 |
| Intermediate risk medicine via abbreviated evaluation | 246 | 281 | 282 | 497 |
| Intermediate risk medicine via full evaluation | 286 | 400 | 471 | 563 |
| Lower risk medicine | 346 | 487 | 511 | 605 |
| Priority assessment via abbreviated evaluation | 198 | 198 | 198 | 198 |
| Priority assessment via full evaluation | 372 | 374 | 374 | 470 |
Number of applications received
| Application type | 2010 | 2011 | 2012 |
|---|---|---|---|
| Higher risk medicine | 37 (45% abbreviated) | 34 (44% abbreviated) | 38 (36% abbreviated) |
| Intermediate risk medicine | 117 (49% abbreviated) | 100 (49% abbreviated) | 97 (55% abbreviated) |
| Lower risk medicine | 92 | 88 | 52 |
| Changed medicine | 1397 | 1459 | 1457 |
Performance against evaluation timeframes 2011
