Medicines

Medsafe’s performance in the evaluation of new and changed medicines during 2014

Total number of applications received – 1 January to 31 December 2014

Application type Received Higher risk medicine 56 (70% abbreviated, 13 priority) Intermediate risk medicine 83 (60% abbreviated, 15 priority) Lower risk medicine 58 Changed medicine 1525

Total number of applications granted consent – 1 January to 31 December 2014

Application type Consented Higher risk medicine 40 Intermediate risk medicine 93 Lower risk medicine 53 Changed medicine 1432 S24(5) referrals 49 (3%)

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

91% of new medicine applications had an initial assessment completed within 200 calendar days

100% 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 applications via full evaluation 37% (6 of 16) completed within 200 days



80% within 232 days 96% within 200 days 87% within 120 days 100% of within 120 days 77% within 120 days Higher risk medicine applications via abbreviated evaluation 87% (33 of 38) within 100 days Intermediate risk medicine applications via full evaluation 72% (26 of 36) within 200 days

80% within 205 days 88% within 200 days 87% within 120 days 87% within 120 days 95% within 120 days Intermediate risk medicine applications via abbreviated evaluation 80% (38 of 47) completed within 100 days Lower risk medicine applications 98% (49 of 50) within 200 days 91% within 200 days 100% within 120 days 88% within 120 days 100% within 120 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 2nd response N1 30% of applications 92% (12 of 13) within 30 days 60% within 7 days 60% within 7 days.



80% within 9 days. Not applicable No applicable N3 43% of applications 50% (21 of 42) within 60 days



80% within 68 days 21% within 30 days 60% within 30 days



80% within 34 days 50% within 30 days 90% within 30 days N4 16% of applications 70% (10 of 14) within 90 days



80% within 97 days 30% within 30 days 92% within 30 days 50% within 30 days 50% within 30 days



80% within 49 days N5 10% of applications 37% (3 of 8) within 120 days



80% within 152 days 75% within 60 days 100% within 60 days In progress





Application Type/ Event Initial evaluation Requests for information Evaluation responses Changed medicine notifications 95% (1382 of 1444) within 21 days 70% within 21 days 99% within 30 days

Total time to conclude prescription medicine applications (2014)

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 465 562 564 731 Higher risk medicine via abbreviated evaluation 270 283 319 357 Intermediate risk medicine via full evaluation 490 613 688 781 Intermediate risk medicine via abbreviated evaluation 324 346 381 456 Priority assessment via full evaluation 154 182 234 305 Priority assessment via abbreviated evaluation 143 130 156 156

Regulator time taken to conclude applications (2014)

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 302 435 464 Higher risk medicine via abbreviated evaluation 204 235 245 Intermediate risk medicine via full evaluation 328 439 486 Intermediate risk medicine via abbreviated evaluation 232 288 324 Priority assessment via full evaluation 125 184 267 Priority assessment via abbreviated evaluation 115 126 126

Total time to conclude lower risk (OTC) medicine applications submitted via new business rule (2014)

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 73 69 77 108 N3 226 272 289 364 N4 319 370 370 370 N5 No applications concluded in 2014

Number of applications received during the previous four years

Application type 2011 2012 2013 2014 Higher risk medicine 33 (44% abbreviated) 44 (36% abbreviated) 49 (57% abbreviated) 56 (70% abbreviated) Intermediate risk medicine 101 (49% abbreviated) 98 (55% abbreviated) 109 (62% abbreviated) 83 (60% abbreviated) Lower risk medicine 86 52 63 58 Changed medicine 1460 1457 1369 1525

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 against evaluation timeframes 2013

Performance against evaluation timeframes 2012

Performance against evaluation timeframes 2011