Applications to register new or vary existing prescription medicines are accompanied by supportive scientific data and evaluated, with timeframes underpinned by legislation and/or associated business rules.

The framework for prescription medicines includes the following categories which are subject to legislated timeframes:

• Category 1 application: An application to register a new prescription medicine (other than an additional trade name) or to make a variation to an existing medicine that involves the evaluation of clinical, pre clinical or bio-equivalence data. For example, new chemical entities, extensions of indication and new routes of administration.

  The legislated timeframes for the two stages of a Category 1 application are: 40 working days for notification of acceptance or rejection of the application and 255 working days for the completion of the evaluation and notification of the decision.

• Category 2 application: An application accompanied by two independent evaluation reports from comparable overseas regulators in whose jurisdiction the product is approved for the same indication.

  The legislated timeframes for the two stages of a Category 2 application are: 20 working days for notification of acceptance or rejection of an application and 175 working days to notify the applicant of the decision.

• Category 3 application: An application to register or to vary the registration of a prescription medicine where the application does not require the support of clinical, pre clinical or bio-equivalence data. For example, a change in the site of manufacture, a change to the synthetic route, a change in the product specifications, a change in the steps of manufacture or a change in trade name.

  The legislated timeframe for a Category 3 application is 45 working days for notification of acceptance or rejection of an application, completion of evaluation and notification of the decision.

On this page: 1.1. Approval times | 1.2. Submission outcomes | 1.3. Other applications | 1.4. Orphan drug designations

1.1. Approval times

Once an application has been accepted by the TGA, the approval time is defined as the number of TGA working days until a decision is made. As detailed above, this timeframe is underpinned by legislation and excludes public holidays, weekends, the time allocated to the applicant to provide responses to requests for information and 'mutual clock stop' periods agreed with the applicant.

In accordance with the Therapeutic Goods Regulations 1990, a 'submission' may include a number of applications submitted at the one time. The data presented below relates to submissions as this best reflects the evaluation and decision-making processes.

Figure 1 Submissions received 2015-16 to 2016-17

Figure 1 in table format

Figure 1 Submissions received 2015-16 to 2016-17

Application type	Jul 15 - Jun 16	Jul 16 - Jun 17
New chemical entity	43	43
Extension of indication	46	56
New generic medicine	142	100

Figure 2 Mean approval times 2015-16 to 2016-17

Figure 2 in table format

Figure 2 Mean approval times 2015-16 to 2016-17

Application type	Jul 15 - Jun 16	Jul 16 - Jun 17
New chemical entity	193	220
Extension of indication	186	198
New generic medicine	170	182

Figure 3 Median approval times 2015-16 to 2016-17

Figure 3 in table format

Figure 3 Median approval times 2015-16 to 2016-17

Application type	Jul 15 - Jun 16	Jul 16 - Jun 17
New chemical entity	199	208
Extension of indication	195	202
New generic medicine	158	172

1.2. Submission outcomes

1.3. Other applications

In addition to the application types discussed above, we also process numerous other application types. These applications are assessed in accordance with a risk-based approach, for example, some requests are categorised as 'self-assessable' and do not usually involve the evaluation of scientific data. Some applications are received because the sponsors are obliged to inform the TGA of new information related to the safety of their products. Other applications involve editorial corrections to the register entry or the associated product information document. The number of these applications is presented below.

In accordance with the legislation, registered medicines must comply with numerous standards at the time they are registered and throughout their lifecycle. Following an appropriate application and review of the scientific data and safety considerations, we may grant an 'exemption' from a particular standard for a product. The number of applications approved and rejected is also presented below.

1.4. Orphan drug designations

'Orphan drugs' are often developed to treat small and very specific patient populations who suffer from rare diseases and conditions. The application and evaluation fees for orphan drugs can be waived to help reduce their development costs and facilitate their access to the Australian marketplace. A medicine needs to be designated by the TGA as an orphan drug before an application can be accepted to register it on the ARTG. The designation process involves a review of whether the drug meets the established criteria which are underpinned by legislation.

The quality, efficacy and safety of orphan drugs are assessed at the same standard as for other registered prescription medicines.