Approval of New Prescription Medications

For a prescription medication to be registered on the Australian Register of Therapeutic Goods (ARTG), the sponsor must lodge a complete dossier with the Therapeutic Goods Administration (TGA). This submission must contain, or provide reference to, data to demonstrate the quality, safety, and efficacy of the medicine.

This registration process takes, on average, 11 months. However, medications for serious and life-threatening conditions may be eligible for fast track approval using the priority review or provisional approval pathway.

Priority review pathway

Priority review allows approval of prescription medicines up to three months quicker than the usual process. Sponsors are required to submit the same amount of evidence as needed for the standard approval pathway, but the TGA commits to reviewing the data and making a decision earlier.

For a medicine to be eligible for a priority review, it must be a new treatment for a serious or life-threatening condition, and there must be substantial evidence to demonstrate that the medicine provides a significant benefit over existing therapies.

Provisional approval pathway

It may sometimes be considered appropriate to approve a medication when there is less evidence available. In such cases, the TGA allows medicines to be provisionally approved while further research is conducted. It is anticipated that the provisional approval pathway could allow Australians to receive major therapeutic advances up to two years faster than the usual process.

For a medicine to be eligible for provisional approval, it must meet the following criteria:

• Be a new prescription medicine or an already registered prescription medicine that has a new indication;
• Be indicated for the treatment, prevention, or diagnosis of a life-threatening or seriously debilitating condition;
• Either no therapeutic goods are fully registered for the same indication, or preliminary clinical data demonstrates that the medicine is likely to provide a significant improvement over existing therapeutic goods;
• Preliminary clinical data demonstrates that the medicine is likely to be a major therapeutic advance; and
• Evidence must be provided of a plan to submit more comprehensive clinical data before the end of the provisional registration period.

An example of a recent provisionally approved medicine is remdesivir. Remdesivir is an antiviral that has shown promise as a treatment for severe coronavirus infection. The TGA provided provisional approval for this agent within two weeks of receiving the submission due to the potential for substantial benefit to Australian patients.

When provisional approval is granted, it is valid for an initial period of two years. However, up to two extensions may be granted, taking the maximum approval period to six years under this pathway. Medicines that have received a provisional approval are identified as such in the product information and consumer medicines information documents. These medicines are also automatically included in the Black Triangle Scheme, and healthcare professionals are encouraged to report any suspected side effects to the TGA to build the medicine’s safety profile further.