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Medicines

Revised: 27 May 2013

Medsafe's performance in the evaluation of new and changed medicines during 2011

From 1 January to 31 December 2011 the following trends and performance were observed.

Work flows

Application type Number of applications
Received Consented
Higher risk medicine 33 (45% abbreviated) 36
Intermediate risk medicine 101 (40% abbreviated) 117
Lower risk medicine 86 90
Changed medicine 1460 1455

More medicines are consented than received 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

Number of applications 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 12 of 19 (63%) applications completed within 200 days 92% of applicants responded within 200 days
95% completed within 200 days
93% of applicants responded within 120 days 90% completed within 120 days
Higher risk medicine applications via abbreviated evaluation 20 of 24 applications (83%) completed within 200 days
Intermediate risk medicine applications via full evaluation 54 of 58 applications (93%) completed within 200 days 92% of applicants responded within 200 days
97% completed within 120 days
98% of applicants responded within 120 days
93% completed within 120 days
Intermediate risk medicine applications via abbreviated evaluation 39 of 46 applications (85%) completed within 100 days
Lower risk medicine applications 91 of 94 applications (97%) completed within 100 days 87% of applicants responded within 200 days 93% completed within 120 days
89% of applicants responded within 120 days 95% completed within 120 days

Application Type/ Event Initial evaluation Requests for information Evaluation responses
Changed medicine notifications 1435 of 1476 notifications (97%) reviewed within 21 days Requests for information issued on 20% of notifications
56% of applicants responded within 21 days
93% reviewed within 21 days

2% of notifications required referral under s24(5) of the Medicines Act 1981.

Time to conclude 75% of applications

The time to conclude an application is the total time in calendar days from the day the application was received until an outcome letter is issued. The time includes company response time, which is an average of 100 days for prescription medicine applications and 160 days for over-the counter medicine applications.

  Time in calendar days
(75% of applications)
Application type 2007 2008 2010 2011
Innovative prescription medicine 613 535 289 120
Innovative prescription medicine (abbreviated) N/A 253 281 107
Generic prescription medicine 697 605 368 212
Generic prescription medicine (abbreviated) 326 326 228 150
Over the counter medicine 508 512 366 218
Priority assessment 515 312 196 212
Priority assessment (abbreviated) N/A N/A 98 148

Note: some applications received in 2011 are not yet complete. N/A means no applications received of that type.

Graph of Time to Conclude 75% of applications

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