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TGA key performance indicators: January to June 2015
Version 1.0, August 2015
The TGA makes decisions whether to approve or reject market authorisation of medicines, medical devices and blood and tissues that are imported, exported, manufactured and supplied in Australia. This KPI provides evidence about whether we are enabling timely access to therapeutic goods for the Australian public.
We aim to ensure that all of the applications for market authorisation of therapeutic goods are processed within target timeframes. There are different targets in place for the time taken to make a regulatory decision, depending on the type of therapeutic good. Some of these targets are specified in the legislation. Timeframes exclude 'hold times' where the TGA is awaiting a response from an applicant following a request for information, and includes any time for committee consideration.
|Pre-market business operations||Jan - Jun 2015||Jul - Dec 2014||Jan - Jun 2014|
|Applications lodged under the prescription medicines registration process ('Category 1' applications) processed within the legislated timeframe (255 working days)||177 (99%)||164 (100%)||206 (99.5%)|
|Quality related evaluations ('Category 3' applications) processed within the legislated timeframe (45 working days)||723 (98%)||737 (100%)||754 (100%)|
|Non-prescription medicines: new applications1|
|N1 (target timeframe = 45 working days)||56 (100%)||116 (94%)||131 (98%)|
|N2 (target timeframe = 75 working days)||1 (100%)||8 (100%)||2 (100%)|
|N3 (target timeframe = 150 working days)||16 (100%)||21 (100%)||38 (100%)|
|N4 (target timeframe = 170 working days)||15 (100%)||58 (100%)||18 (100%)|
|N5 (target timeframe = 210 working days)||7 (100%)||17 (100%)||1 (100%)|
|Non-prescription medicines: change applications1|
|C1 (target timeframe = 20 working days)||268 (91%)||261 (97%)||184 (84%)|
|C2 (target timeframe = 64 working days)||136 (100%)||134 (99%)||169 (98%)|
|C3 (target timeframe = 120 working days)||2 (100%)||3 (67%)||6 (100%)|
|C4 (target timeframe = 170 working days)||5 (100%)||02||3 (100%)|
|Registered complementary medicines (mean approval time; working days)||4233||1604||02|
|New substances for listed medicines (mean approval time; working days)||1273||239||225|
|Conformity assessments processed within the target timeframe (255 days)||53 (100%)||95 (100%)||137 (100%)|
|Non-compulsory application audits processed within the target timeframe5 (30 working days)6||156 (72%)||133 (54%)||478 (38%)7|
|Level 1 application audits processed within the target timeframe5 (30 working days)||11 (100%)||13 (77%)||16 (60%)|
|Level 2 application audits processed within the target timeframe5 (60 working days)||155 (46%)||156 (18%)8||205 (60%)|
|In vitro diagnostic medical devices|
|Conformity assessments processed within the target timeframe (255 days)||12 (100%)||25 (100)%||24 (100%)|
|Non-compulsory application audits processed within the target timeframe (60 working days)||4 (100%)||8 (50%)||6 (33%)|
|Mandatory technical file reviews processed within the target timeframe (60 working days)||71 (100%)||78 (83%)||69 (91%)|
- Data for new and change applications were reported differently prior to 2014. The data reported are the total number of applications completed during the reporting period and the percentage that were completed within target timeframes. Further details of the different types of applications for non-prescription medicines are available in the Australian Regulatory Guidelines for Non-prescription Medicines. The different application types for non-prescription medicines are:
- N1: an application submitted as a 'Clone'
- N2: an application which complies with an over-the-counter medicine monograph
- N3: a new application for a 'generic' medicine other than those 'generic' applications in levels N1, N2 or N4
- N4: an application for a 'generic' medicine where the medicine:
- is included in Appendix X of the Over-the-counter Application Categorisation Framework (but which is not a level N1 application) and/or
- includes an umbrella branded product name where the umbrella segment is categorised as requiring a higher level of assessment and/or
- requires supporting safety and/or efficacy (clinical/toxicological) data or a justification for not providing such data.
- N5: an application for a new product that is an extension to a 'Generic category' product or an application for a product containing a new chemical entity as an active ingredient.
- C1: quality and non-quality changes - self assessable requests and safety related requests
- C2: quality changes or non-quality changes - no safety and efficacy data required
- C3: umbrella branding - higher level of assessment or non-quality changes - safety and efficacy data may be required
- C4: non-quality changes - data are required.
- There were no approvals for this application type during the reporting period.
- These data are for a single application.
- There were three applications approved, which were different dosage forms of the same product line. Thus, the average time for completion of the three individual applications is divided by 3 for reporting purposes.
- The audit period commences when the sponsor is notified that the application is selected for audit. Previously, due to certain limitations the target timeframe in this report was calculated inclusive of the 20 working days period from when the application is made (application fee paid) during which time the TGA may select the application for auditing. The figures for the last 6 months (January - June 2015), the report refers to the actual audit time, i.e. excluding initial 20 working days prescribed under the legislation.
- The figures for non-compulsory audits do not include applications for reclassification of total or partial shoulder, hip, or knee joint replacement medical devices. These applications are not subject to the agreed target timeframe.
- The January-June 2014 figure incorrectly includes numbers for Joint Implant Reclassification applications that are not subject to the agreed target timeframe. The correct figures are: there were 225 non-compulsory application audits processed in January to June 2014, of which 32% were completed within the 30 TGA working day target time frame.
- The intricate nature of these audits vary considerably and during this reporting period the majority of audits undertaken were of significant complexity.