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Medicines

Revised: 27 May 2013

Medsafe’s performance in the evaluation of new and changed medicines during 2012

From 1 January to 31 December 2012 the following trends and performance were observed.

Work flows

Application type Number of applications
Received Consented
Higher risk medicine 38 (36% abbreviated) 35
Intermediate risk medicine 97 (55% abbreviated) 74
Lower risk medicine 52 56
Changed medicine 1457 1430


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 preceeding 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 9 of 12 (75%) applications completed within 200 days 83% of applicants responded within 200 days 95% completed within 200 days 60% of applicants responded within 120 days 85% completed within 120 days
Higher risk medicine applications via abbreviated evaluation 16 of 18 applications (89%) completed within 100 days
Intermediate risk medicine applications via full evaluation 24 of 26 applications (92%) completed within 200 days 82% of applicants responded within 200 days 96% completed within 120 days 82% of applicants responded within 120 days 92% completed within 120 days
Intermediate risk medicine applications via abbreviated evaluation 47 of 48 applications (98%) completed within 100 days
Lower risk medicine applications 39 of 44 applications (88%) completed within 100 days 80% of applicants responded within 200 days 96% completed within 120 days 85% of applicants responded within 120 days 97% completed within 120 days


Application Type/ Event Initial evaluation Requests for information Evaluation responses
Changed medicine notifications 1415 of 1429 notifications (99%) reviewed within 21 days Requests for information issued on 20% of notifications

63% of submitters responded within 21 days
97% reviewed within 21 days

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

Time to conclude applications (2012)

Application type Mean 75% 80% 90%
Higher risk medicine via abbreviated evaluation 399 415 415 829
Higher risk medicine via full evaluation 339 469 522 779
Intermediate risk medicine via abbreviated evaluation 246 281 282 497
Intermediate risk medicine via full evaluation 286 400 471 563
Lower risk medicine 346 487 511 605
Priority assessment via abbreviated evaluation 198 198 198 198
Priority assessment via full evaluation 372 374 374 470

Number of applications received

Application type 2010 2011 2012
Higher risk medicine 37 (45% abbreviated) 34 (44% abbreviated) 38 (36% abbreviated)
Intermediate risk medicine 117 (49% abbreviated) 100 (49% abbreviated) 97 (55% abbreviated)
Lower risk medicine 92 88 52
Changed medicine 1397 1459 1457

 

Time to conclude 80% of applications

Performance against evaluation timeframes 2011

 

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