Revised: 31 January 2018

Medicines

Medsafe’s performance in the evaluation of new and changed medicines during 2017

Total number of applications received - 1 January to 31 December 2017

Application type Received
Higher risk medicine 41 (46% abbreviated)
Intermediate risk medicine 65 (68% abbreviated)
Lower risk medicine 55
Changed medicine 1249
Priority assessment 10

Total number of applications granted consent - 1 January to 31 December 2017

Application type Consented
Higher risk medicine 48
Intermediate risk medicine 51
Lower risk medicine 44
Changed medicine 1241

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

Referred 64 (5%)
Consented 58


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

  • 88% of new medicine applications had an initial assessment completed within 200 calendar days
  • 99.7% 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 application (full evaluation) 50% (13 of 26) within 200 days
80% within 222 days
97% within 200 days 37% within 120 days 81% within 120 days 47% within 120 days
Higher risk medicine application (abbreviated evaluation) 33% (9 of 27) within 100 days
90% within 190 days
Intermediate risk medicine application (full evaluation) 70% (19 of 27) within 200 days
80% within 219 days
85% within 200 days 33% within 120 days 89% within 120 days 48% within 120 days
Intermediate risk medicine application (abbreviated evaluation) 63% (32 of 51) within 100 days
90% within 139 days
Lower risk medicine application 100% (51 of 51) within 200 days 92% within 200 days 100% within 120 days 96% within 120 days 71% within 120 days

 

  Initial evaluation Requests for information Evaluation of responses
Changed medicine notifications 80% (1045 of 1300) within 21 days 50% within 21 days 71% 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
50% (7 of 14) within 30 days
80% within 60 days
60% within 7 days 25% within 7 days
80% within 14 days
17% within 7 days 83% within 21 days
100% within 27 days
N3
56% of applications
42% (10 of 24) within 60 days
80% within 105 days
11% within 30 days 50% within 30 days
80% within 101 days
65% within 30 days 70% within 30 days
80% within 35 days
N4
5% of applications
50% (4 of 8) within 90 days
80% within 99 days
0% within 30 days 0% within 30 days
100% within 55 days
0% within 30 days 0% within 30 days
100% within 41 days
N5
24% of applications
40% (2 of 5) within 120 days
80% within 191 days
17% within 60 days 50% within 60 days
100% within 70 days
33% within 60 days 0% within 60 days
80% within 184 days

Total time to conclude prescription medicine applications (2017)

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 503 757 813 837
Higher risk medicine via abbreviated evaluation 411 397 403 604
Intermediate risk medicine via full evaluation 711 851 966 991
Intermediate risk medicine via abbreviated evaluation 478 528 556 765
Priority assessment via full evaluation 132 161 194 194
Priority assessment via abbreviated evaluation 225 225 225 225

Regulator time taken to conclude applications (2017)

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 342 419 488
Higher risk medicine via abbreviated evaluation 307 331 426
Intermediate risk medicine via full evaluation 516 678 698
Intermediate risk medicine via abbreviated evaluation 342 419 488
Priority assessment via full evaluation 114 165 165
Priority assessment via abbreviated evaluation 197 197 197

Total time to conclude lower risk (OTC) medicine applications submitted (2017)

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 193 225 269 95
N3 390 422 532 574
N4 318 318 318 318
N5 714 793 793 896

Number of applications received during the previous five years

Application type 2013 2014 2015 2016 2017
Higher risk medicine 49 (57% abbreviated) 56 (70% abbreviated) 60 (60% abbreviated) 48 (50% abbreviated) 41 (46% abbreviated)
Intermediate risk medicine 109 (62% abbreviated) 83 (60% abbreviated) 75 (50% abbreviated) 73 (70% abbreviated) 65 (68% abbreviated)
Lower risk medicine 63 58 50 23 55
Changed medicine 1369 1525 1415 1392 1249
Priority assessment 4 12 10 8 10

Comparison of the total time to conclude prescription medicine applications during the previous five 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 2016

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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