The question on clients’ lips… “How long will my application take?”

04 November 2019 |

Stairs with light

Every year the TGA produce the TGA Annual Performance Statistics Report and the Half Yearly Performance Snapshot.

On the 21 October 2019, the TGA released the latest annual statistics on the application timeframes for medicines, complementary medicines, medical devices, in vitro diagnostic devices (IVDs), vaccines, blood products, and other biologics from 1st July 2018 to 30th June 2019 in the Annual Performance Statistics Report July 2018-June 2019, Therapeutic Goods Administration, Version V1.0.

It should be noted that the TGA work within a framework for how long the application process for therapeutic goods should be completed by.

For medical devices, The Therapeutic Goods (Medical Devices) Regulations 2002 stipulate that… “The Secretary must make a decision on the application within 255 working days after the application is received” starting from when “an application for the issue of a conformity assessment certificate in respect of a kind of medical device if… the Secretary is required to examine the design of the device.”

Likewise, the timeframes for medicines are legislated. Divided by application category; Category 1 for new prescription medicine or new chemical entities can take up to 255 working days, Category 2 application that have reports supported by Comparable Overseas Regulator (COR) require a decision in 120 days or 175 days depending on the amount and type of any additional data requiring evaluation, as well as the age of the assessment report.

Two hundred and fifty-five working days equates to a calendar year in working days. But the clock stops every time the application is returned to the sponsor or agent to address a query, a request for further information, or when an appeal is lodged in relation to the application. The clock can also be stopped when the TGA and the applicant or sponsor agree in writing.

Taking that all into account 255 working days can blow out to be much longer than a calendar year.

But bringing it back to the statistics… How long does it “usually” take to get my product approved?

While the statistics in the report may not be indicative of your application, it does provide some guidance on the average time it takes for an application to get through.

Device Timeframes:

For Medical Devices, the processing timeframes have been split between Conformity Assessment applications and applications for inclusion.

The time taken for the TGA to complete a Conformity Assessment is as follows:

While there are mandated timeframes for Conformity Assessments (255 days), there are none of the applications for inclusion. The TGA try to work with a target timeframe 30 workdays for Level 1 application audits and 60 workdays for Level 2 application audits.

With the statistics on the applications for inclusion in the ARTG, the TGA have not provided details on the time taken to complete these applications when an audit not requested. But the statistics for applications for inclusion that included an audit are as follows:

The statistics show that the time taken to complete a Conformity Assessment application is pretty stable from 2017-2018, but that the applications for inclusion are a bit of a mixed bag.

Medicine Timeframes:

For medicines, the approval times are as follows:

The time taken to complete these application types is pretty consistent with the statistics from 2017-2018 with a few exceptions of some improvements seen in Category 1 G: Minor variation, and H: Minor variation applications.

The statistics only go so far…

Overall, the time taken for a medical device or medicine application to the TGA is stable from 2017 – 2018, with some notable caveats. But this is only part of the part of the picture.

The TGA as a regulator is responsible for ensuring that all therapeutic goods made available in Australia are safe and fit for use. In doing this, the TGA can only assess the data and information that is available to them during the assessment process. The statistics can provide some guidance as to how long it may take your application to get approved, but the timeframe with any particular application are dependent on a number of factors.

When making an application to the TGA, there are a couple of important points to remember:

  1. There are mandated timeframes set out for the TGA to approve an application for medicines and medical device conformity assessments, but there are a number of medical device application types for which there are no mandatory timeframes.
  2. The clock stops whenever an application is returned to the applicant or the sponsor for clarification or an information request. The fewer requests for information, the fewer times there is a delay.
  3. The statistics provided give a snapshot of past performance that may not reflect future conduct.

Critical to the timeframe of any application is the strength of the supporting documentation; this is the only way to “beat the stats”.

If you are interested in the complete picture, the Annual Performance Statistics Report July 2018-June 2019 has more than just the approval times; the report contains details on the number of applications made, the number of successful applications, statistics on the number of product recalls, adverse event reporting, export only applications, laboratory testing, post-market and pharmacovigilance, inspections, and much much more. The full report can be found here.

If you have any questions about how long your application may take or the best way to streamline the application process, be sure to reach our the Brandwood CKC for a no-obligation discussion.

The tables included in this blog have been recreated from Annual Performance Statistics Report July 2018-June 2019, Therapeutic Goods Administration, Version V1.0, 21 October 2019.

If you have questions about how to navigate the use of standards and managing test programs, please reach out. We have a staff of consultants with extensive expertise. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)


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