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Medicines

11 October 2017

Medsafe’s performance in the evaluation of new and changed medicines during 2016

Total number of applications received - 1 January to 31 December 2016

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

Total number of applications granted consent - 1 January to 31 December 2016

Application type Consented
Higher risk medicine 48
Intermediate risk medicine 79
Lower risk medicine 24
Changed medicine 1378

Section 24(5) Referrals - 1 January to 31 December 2016

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.

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 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

Lower risk medicine applications submitted

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

Total time to conclude prescription medicine applications (2016)

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

Regulator time taken to conclude applications (2016)

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

Total time to conclude lower risk (OTC) medicine applications submitted (2016)

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

Number of applications received during the previous four years

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

Comparison of the total time to conclude prescription medicine applications 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.

Time to conclude 80% of applications

The following graph represents the regulator time to conclude the stated proportion of applications in calendar days exclusive of applicant response time.

Regulator time 80% of applications

Performance against evaluation timeframes 2015

Performance against evaluation timeframes 2014

Performance against evaluation timeframes 2013

Performance against evaluation timeframes 2012

Performance against evaluation timeframes 2011

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