Revised: 12 February 2014
Medicines
Medsafe’s performance in the evaluation of new and changed medicines during 2013
Total number of applications received– 1 January to 31 December 2013
| Application type | Received |
|---|---|
| Higher risk medicine | 49 (57% abbreviated) |
| Intermediate risk medicine | 109 (62% abbreviated) |
| Lower risk medicine | 63 |
| Changed medicine | 1369 |
Total number of applications granted consent– 1 January to 31 December 2013
| Application type | Consented |
|---|---|
| Higher risk medicine | 36 |
| Intermediate risk medicine | 78 |
| Lower risk medicine | 54 |
| Changed medicine | 1423 |
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
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 | 12 of 19 applications (63%) completed within 200 days | 90% of applicants responded within 200 days | 87% completed within 200 days | 92% of applicants responded within 120 days | 85% completed within 120 days |
| Higher risk medicine applications via abbreviated evaluation | 14 of 17 applications (82%) completed within 100 days | ||||
| Intermediate risk medicine applications via full evaluation | 25 of 50 applications (50%) completed within 200 days | 92% of applicants responded within 200 days | 75% completed within 120 days | 89% of applicants responded within 120 days | 80% completed within 120 days |
| Intermediate risk medicine applications via abbreviated evaluation | 59 of 74 applications (80%) completed within 100 days | ||||
| Lower risk medicine applications | 53 of 61 applications (87%) completed within 100 days | 86% of applicants responded within 200 days | 92% completed within 60 days | 90% of applicants responded within 120 days | 97% completed within 60 days |
| Application Type/ Event | Initial evaluation | Requests for information | Evaluation responses |
|---|---|---|---|
| Changed medicine notifications | 1372 of 1423 notifications (96%) reviewed within 21 days | Requests for information issued on 23% of notifications
65% of submitters responded within 21 days |
90% reviewed within 21 days |
3% of notifications required referral under s24(5) of the Medicines Act 1981. |
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Time to conclude applications (2013)
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 | 75% | 80% | 90% |
| Higher risk medicine via full evaluation | 424 | 520 | 540 | 806 |
| Higher risk medicine via abbreviated evaluation | 244 | 347 | 347 | 378 |
| Intermediate risk medicine via full evaluation | 525 | 595 | 644 | 757 |
| Intermediate risk medicine via abbreviated evaluation | 237 | 310 | 325 | 371 |
| Lower risk medicine | 331 | 399 | 476 | 757 |
| Priority assessment via full evaluation | 269 | 291 | 291 | 472 |
| Priority assessment via abbreviated evaluation | 107 | 108 | 108 | 120 |
Regulator time taken to conclude applications (2013)
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 | 294 | 350 | 474 |
| Higher risk medicine via abbreviated evaluation | 172 | 229 | 252 |
| Intermediate risk medicine via full evaluation | 341 | 392 | 450 |
| Intermediate risk medicine via abbreviated evaluation | 162 | 214 | 238 |
| Lower risk medicine | 176 | 235 | 317 |
| Priority assessment via full evaluation | 206 | 225 | 342 |
| Priority assessment via abbreviated evaluation | 75 | 66 | 95 |
Number of applications received during the previous four years
| Application type | 2010 | 2011 | 2012 | 2013 |
|---|---|---|---|---|
| Higher risk medicine | 37 (45% abbreviated) | 34 (44% abbreviated) | 38 (36% abbreviated) | 49 (57% abbreviated) |
| Intermediate risk medicine | 117 (49% abbreviated) | 100 (49% abbreviated) | 97 (55% abbreviated) | 109 (62% abbreviated) |
| Lower risk medicine | 92 | 88 | 52 | 63 |
| Changed medicine | 1397 | 1459 | 1457 | 1369 |
Comparison of the total time to conclude applications during the previous four years
Performance against evaluation timeframes 2012
Performance against evaluation timeframes 2011
