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Medicines

Revised: 12 February 2014

Medsafe’s performance in the evaluation of new and changed medicines during 2013

Total number of applications received– 1 January to 31 December 2013

Application type Received
Higher risk medicine 49 (57% abbreviated)
Intermediate risk medicine 109 (62% abbreviated)
Lower risk medicine 63
Changed medicine 1369

 

Total number of applications granted consent– 1 January to 31 December 2013

Application type Consented
Higher risk medicine 36
Intermediate risk medicine 78
Lower risk medicine 54
Changed medicine 1423

 

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

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 applications  (63%) completed within 200 days 90% of applicants responded within 200 days 87% completed within 200 days 92% of applicants responded within 120 days 85% completed within 120 days
Higher risk medicine applications via abbreviated evaluation 14 of 17 applications (82%) completed within 100 days
Intermediate risk medicine applications via full evaluation 25 of 50 applications (50%) completed within 200 days 92% of applicants responded within 200 days 75% completed within 120 days 89% of applicants responded within 120 days 80% completed within 120 days
Intermediate risk medicine applications via abbreviated evaluation 59 of 74 applications (80%) completed within 100 days
Lower risk medicine applications 53 of 61 applications (87%) completed within 100 days 86% of applicants responded within 200 days 92% completed within 60 days 90% of applicants responded within 120 days 97% completed within 60 days


Application Type/ Event Initial evaluation Requests for information Evaluation responses
Changed medicine notifications 1372 of 1423 notifications (96%) reviewed within 21 days Requests for information issued on 23% of notifications

65% of submitters responded within 21 days
90% reviewed within 21 days

3% of notifications required referral under s24(5) of the Medicines Act 1981.

Time to conclude applications (2013)

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 75% 80% 90%
Higher risk medicine via full evaluation 424 520 540 806
Higher risk medicine via abbreviated evaluation 244 347 347 378
Intermediate risk medicine via full evaluation 525 595 644 757
Intermediate risk medicine via abbreviated evaluation 237 310 325 371
Lower risk medicine 331 399 476 757
Priority assessment via full evaluation 269 291 291 472
Priority assessment via abbreviated evaluation 107 108 108 120

Regulator time taken to conclude applications (2013)

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 294 350 474
Higher risk medicine via abbreviated evaluation 172 229 252
Intermediate risk medicine via full evaluation 341 392 450
Intermediate risk medicine via abbreviated evaluation 162 214 238
Lower risk medicine 176 235 317
Priority assessment via full evaluation 206 225 342
Priority assessment via abbreviated evaluation 75 66 95

 Number of applications received during the previous four years

Application type 2010 2011 2012 2013
Higher risk medicine 37 (45% abbreviated) 34 (44% abbreviated) 38 (36% abbreviated) 49 (57% abbreviated)
Intermediate risk medicine 117 (49% abbreviated) 100 (49% abbreviated) 97 (55% abbreviated) 109 (62% abbreviated)
Lower risk medicine 92 88 52 63
Changed medicine 1397 1459 1457 1369

Comparison of the total time to conclude applications during the previous four years

Graph comparing performance 2010-2013

Performance against evaluation timeframes 2012

Performance against evaluation timeframes 2011

 

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