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Medicines

 4 March 2016

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

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

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

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 2015

Performance against evaluation timeframes 2014

Performance against evaluation timeframes 2013

Performance against evaluation timeframes 2012

Performance against evaluation timeframes 2011

0 1 2 4 5 6 7 9 [ /