How long does it take to evaluate a prescription medicine?
9 October 2008
The time taken by the TGA to evaluate an application for registration of a prescription medicine depends on a number of factors.
When a sponsor applies for the registration of a new prescription medicine, the TGA must decide within 40 working days whether it will accept the application for evaluation. If it decides to accept the application, the TGA must then complete the evaluation and make a decision on registration of the product within a further 255 working days. A working day is any day other than a weekend or a public holiday in the ACT. If the TGA fails to complete the evaluation within 255 working days, it forfeits 25% of the evaluation fee otherwise payable by the sponsor. These requirements are laid down in the Therapeutic Goods Act 1989.
If, during the evaluation, the TGA has to ask the sponsor for additional information so that the evaluation can be completed, the evaluation "clock" stops while the TGA is waiting for the sponsor to reply. Thus time spent waiting for a response from the sponsor is not included in the 255 working days. The TGA refers to the period while the evaluation clock is stopped as "sponsor time".
In practice, the TGA completes its evaluations of prescription medicines, on average, well within the maximum time limits, and very rarely exceeds the time limit on any application.
The factors on which the evaluation time depends include the following.
The type of application
If the active ingredient in the medicine has not previously been approved for use in Australia, the evaluation will usually take longer than if the product is, for example, a generic version of an approved product or a reformulated version of an approved product. If the sponsor is only seeking an additional brand name for an existing product and there are no other changes, the application can usually be evaluated in less than 45 working days. If the sponsor is varying an existing product and the evaluation does not require clinical, non-clinical or bioavailability data, the TGA has only 45 working days to complete the evaluation.
The quality of the application
The quality of the information package supplied to the TGA in support of an application to register a prescription medicine can vary greatly. If the data are of good quality, the application is well-structured and there are no significant omissions, this will minimise the need for the TGA to seek additional information, and will minimise the "sponsor time" during the evaluation. The more frequently the TGA finds it necessary to ask for additional information, the longer both the number of TGA working days and the sponsor time are likely to be.
The TGA accepts submissions in the European Union (EU) Common Technical Document (CTD) format <http://www.tga.gov.au/docs/html/eugctd.htm>. This format, along with guidelines for use, can be found on this website. For certain high priority medicines, the TGA may negotiate with the sponsor to accept a data package in the US format.
Time taken for sponsors to respond
When the TGA seeks additional information from a sponsor, the time taken by the sponsor to respond will affect the overall "sponsor time" for the evaluation. In many cases, Australian sponsors refer the TGA's questions to overseas head offices, which can cause delays.
The average times taken by the TGA to evaluate prescription medicine applications of various types are shown below. These times are measured in working days. The table also shows the average length of "sponsor time" during which the evaluation clock was stopped while the TGA waited for the sponsor to respond to a request for information.
Average evaluation times for some typical classes of applications are shown for the last two quarters of the previous financial year and for the whole period from 1992 to 30 June 2008. These figures are for applications completed during the stated period. The TGA evaluation time and the sponsor time must be added to obtain the average total time in working days between acceptance of an application and completion of the delegate’s decision.
| 01/01/92 to 30/06/08 | 01/01/08 to 31/03/08 | 01/04/08 to 30/06/08 | ||||
|---|---|---|---|---|---|---|
| TGA evaluation time (working days) | Sponsor time (working days) | TGA evaluation time (working days) | Sponsor time (working days) | TGA evaluation time (working days) | Sponsor time (working days) | |
| New chemical entity, not previously approved in Australia | 158 | 144 | 180 | 94 | 203 | 96 |
| New indication for an existing medicine | 158 | 45 | 182 | 26 | 204 | 55 |
| New generic version of a previously approved medicine | 135 | 107 | 158 | 91 | 178 | 101 |
Acceptance and evaluation times for orphan drugs
In January 1998 the TGA commenced an orphan drug program aimed at encouraging sponsors of prescription medicines for treatment of rare diseases to register and market these medicines in Australia. Because these medicines are for a very limited number of patients, they are less likely to be commercially attractive to sponsors than medicines with a larger market. If the sponsor can substantiate that a medicine meets orphan drug criteria, the TGA will waive the cost of evaluating the medicine. The TGA also gives priority to the evaluation of medicines which have been designated as orphan drugs.
The average time taken to accept and to evaluate medicines which have been designated orphan drugs <http://www.tga.gov.au/docs/html/orphand2.htm>, and the range of times taken, are shown below. These times relate to applications which were completed between 1 January 2000 and 30 June 2008.
| Acceptance of application for evaluation (TGA working days) | Evaluation of accepted application (TGA working days) | |
|---|---|---|
| New chemical entity, not previously approved in Australia | 26 (range 9-47) | 183 (range 60-255) |
| New orphan drug indication for an existing medicine | 25 (range 6-45) | 164 (range 56-251) |