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	97% within 200 days	37% within 120 days	81% within 120 days	47% within 120 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	85% within 200 days	33% within 120 days	89% within 120 days	48% within 120 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