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TGA key performance indicators: January to June 2015

Version 1.0, August 2015

3 September 2015

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Internal reviews are undertaken when someone affected by a decision requests a review of the decision by the TGA under Section 60 of the Therapeutic Goods Act 1989. In some cases, external review of TGA decisions by the Administrative Appeals Tribunal (AAT) is requested.

8. Internal and external review of TGA decisions
Internal and external review of TGA decisions Jan - Jun 2015 Jul - Dec 2014 Jan - Jun 2014
Internal review1
We make more than 34,000 regulatory decisions every year. Internal reviews are usually only sought on a small number of these decisions (less than 1%).      
Number of requests for internal review processed during the reporting period 13 (100%) 18 (100%) 25 (100%)
Regulatory decisions subject to internal review, for which the original decision is:      
  • initial decision confirmed
9 (69%) 9 (50%) 15 (56%)
  • initial decision revoked, or revoked and substituted2
4 (31%) 6 (33%) 7 (32%)
  • initial decision remitted
0 (0%) 2 (11%) 0 (0%)
  • internal review request withdrawn.
0 (0%) 1 (6%) 3 (12%)
External review
Number of matters referred to the AAT, where the outcome is indicative of an issue about quality of the initial decision.3 0 (0%) 1 (25%) 0 (0%)
  1. The data reported are the number and percentage of decisions subject to internal review.
  2. Additional information was provided to the internal review delegate in all four cases where the initial decision was revoked or revoked and substituted. All internal reviews during the reporting period were completed within target (legislated) timeframes.
  3. Three matters referred by sponsors to the AAT were decided during the reporting period. This figure includes substantive regulatory decisions:
    • to not include products on the Register
    • to remove products from the Register
    • to grant or revoke a manufacturing licence or conformity assessment certificate.

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