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Provisional approval pathway: prescription medicines

20 March 2018

As part of the Government's response to the Review of Medicines and Medical Devices Regulation (MMDR review), we are implementing a pathway for the provisional registration of prescription medicines. Approval through the provisional pathway will be on the basis of preliminary clinical data where there is the potential for a substantial benefit to Australian patients.

In summary

1. Determination process - 3-6 months pre-dossier; 2. Pre-market registration process - Maximum 255 working days; 3. Provisional registration period - 2 year initial period; 4. Extension of provisional registration - 2 possible extensions (each up to 2 years); 5. Transition to full registration - Maximum 255 working days.

The provisional approval pathway allows sponsors to apply for time-limited provisional registration on the Australian Register of Therapeutic Goods (ARTG). It provides access to certain promising new medicines where we assess that the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required.

Provisional registration of prescription medicines under this pathway is limited to a maximum of six years. Registration will automatically lapse at the end of a specified period unless sponsors are able to demonstrate that they have met the conditions imposed on the provisional registration. Sponsors may apply for full registration when sufficient clinical data to confirm the safety and efficacy of the medicine are available.

The Provisional approval pathway consists of five steps as outlined in the Provisional approval diagram [see right]: provisional determination, pre-market registration, the provisional registration period, extension of provisional registration and transition to full registration.

What medicines will be eligible for the provisional approval pathway?

This pathway is available to new prescription medicines or new uses for already registered prescription medicines (new indications medicine).

A determination process will allow us to make a decision regarding whether the prescription medicine is eligible for the provisional approval pathway but does not necessarily mean that the medicine will be provisionally registered after evaluation.

The eligibility criteria are designed to ensure that only medicines providing the most benefit to patients will be provisionally approved. The criteria also require sponsors to demonstrate that they can provide additional clinical data to confirm safety and efficacy within the provisional registration period.

The eligibility criteria are:

  • New prescription medicine or new indications medicine
  • For treating a serious condition
  • Favourable comparison against existing therapeutic goods
  • Major therapeutic advance
  • Evidence of a plan to submit comprehensive clinical data.

Please see our guidance on the eligibility criteria for provisional approval determination for more information.

Prescription medicines that have an approved provisional determination will be published on the designation notices web page.

What are the benefits of the provisional approval pathway?

  • Prescription medicines that provide a major therapeutic advance for Australians could come to the market up to two years sooner than in the current framework.
  • The pathway provides a formal and transparent mechanism for expediting registration of promising new medicines with preliminary clinical data for sponsors and TGA business areas.
  • Increased alignment with other overseas regulators that provide similar pathways.

Applications for provisional approval

Sponsors are strongly encouraged to organise a pre-submission meeting with the TGA to discuss planned applications for provisional determination.

For more information on the application process, see our guidance for sponsors on the provisional approval determination process, provisional registration process, and post market requirements, extensions, and transition to full registration process.

The implementation plan for provisional approval provides more information on how we will implement the pathway. It outlines the timeframes for acceptance of the first determination applications and submissions for provisional registration under the provisional approval pathway.

Please continue to check our website for updates.