Part 1: Overview

June quarter 2016

The APVMA commenced assessment of 1310 applications in the June quarter, comprising of 659 applications for product registration, approval of actives permits.

We finalised 1383 applications in the June quarter, comprising 729 applications for product registration, approval of actives and permits. This was 173 more applications than the previous quarter, with 76 per cent of applications being finalised within legislated timeframes (compared with 64 per cent in the previous three quarters):

  • 78 per cent of product applications were finalised within timeframe (72 per cent for pesticides and 85 per cent for veterinary medicines)
  • 75 per cent of applications for approval of actives and 71 per cent of permit applications were completed within timeframe.

At 30 June 2016, there were 1406 applications or activities in progress. Of these, 1192 were applications for products, actives and permits:

  • this was lower than the work in progress at 31 March 2016, driven primarily by an increase in the number of permit and pesticide applications completed during the quarter.

2015–16 overview

The APVMA commenced assessment of 5106 applications and finalised 5148 applications between July 2015 and June 2016:

  • 2510 applications for registration, 608 consents to import and 1988 other registration activities were commenced
  • of the 2545 product, active and permit applications finalised, approximately 90.5 per cent were granted, with around 2.8 per cent refused by the APVMA and 6.7 per cent of applications withdrawn by the applicants
  • 620 consents to import and 96 manufacturing audits were finalised.

Of the applications still in progress, 79 per cent were within timeframe.

The timeframe performance for applications improved in the June quarter, increasing to 68 per cent of applications finalised within timeframe overall for the year:

  • total product application timeframe performance was 66 per cent: pesticides (57 per cent), veterinary medicines (80 per cent)
  • 70 per cent of applications for actives and permits were completed on time
  • non-technical assessments was 72 per cent overall: pesticide products (60 per cent), veterinary medicine products (92 per cent)
  • applications requiring technical assessment was 55 per cent overall: pesticide products (51 per cent), veterinary medicine products (61 per cent).

Summary of activities related to regulatory decisions in the APVMA July 2015 – June 2016 

Types of regulatory decisions* Commenced Finalised/issued In progress

Pre-application assistance

175 145 42

Product registration—pesticides**

905 1029 408

Product registration—veterinary medicines**

701 704 316

Actives

342 213 289

Permits

562 599 179

Items 8L, 8M, 8P

695 689 32

Item 25

15 24 12

Notifiable variations

736 696 37

Import consents

608 620 61

Certificates of export

367 429 30

Total

5106 5148 1406

*See description of application types.

**A minor change was made in the above table from the last time it was published to reflect the main stakeholder groups. Product registration is now divided by pesticides and veterinary medicines (rather than majors and non-technical). To help the reader to make comparisons with the last report we have prepared a July 2015 to March 2016 table with the new groupings, see below.

Summary of activities related to regulatory decisions in the APVMA July to March 2016

Types of regulator decision Commenced Finalised/issued In progress
Pre-application assistance 144 102 61
Product registration—pesticides 719 734 517
Product registration—veterinary medicines 461 493 284
Actives 199 131 227
Permits 463 458 221
Items 8L, 8M, 8P 577 558 43
Item 25 11 20 12
Notifiable variations 558 531 19
Import consents 403 408 53
Certificates of export 261 330 24
Total 3796 3765 1461

 

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