Medicines

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

85% 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 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	94% within 200 days	48% within 120 days	93% within 120 days	58% within 120 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	91% within 200 days	56% within 120 days	89% within 120 days	55% within 120 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