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	1^st Request for information	Evaluation of 1^st response	2^nd Request for information	Evaluation of 2^nd 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	96% within 200 days	87% within 120 days	100% of within 120 days	77% within 120 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	88% within 200 days	87% within 120 days	87% within 120 days	95% within 120 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 2014