Provisional approval of prescription medicines

Provisional approval allows us to approve some prescription medicines for a limited period of time while more research is conducted.

We use the provisional approval pathway when a new medicine is a promising treatment for a serious or life-threatening condition but there is less research available on the medicine than we would normally require for the approval of a prescription medicine.

On this page: Eligibility for provisional approval | Research, evidence and safety for provisional medicines | Identifying a provisionally approved medicine | Report all side effects | Subsidised medicines through the PBS

Eligibility for provisional approval

Provisional approval provides early access to promising new prescription medicines for serious and life-threatening conditions. However, it is important to be aware that our knowledge of the risks and benefits of these medicines is less certain than other approved prescription medicines.

There are a number of eligibility criteria for the provisional approval. Most importantly:

• it must be a new prescription medicine or a new indication for an existing medicine
• it must provide a favourable comparison against existing therapeutic goods
• it must provide a major therapeutic advance
• the sponsor must provide evidence of a plan to submit comprehensive clinical data.

Research, evidence and safety for provisional medicines

All medicines have side effects. However, when a medicine is new to the market it is impossible for us to know all the possible side effects. Although evidence is still being collected on the medicine, we have assessed the available data and made a decision based on that. To ensure the safety of provisionally approved medicines to the best of our ability, we will:

• make sure all available evidence shows that the benefits of the medicine outweigh any risks
• ensure all applications for approval include a plan on how the drug company will conduct more research on the medicine’s safety and efficacy
• monitor the medicine more closely so that any issues are identified
• limit, suspend or cancel the approval if there are major patient safety concerns.

Identifying a provisionally approved medicine

The Product Information (PI) and Consumer Medicine Information (CMI) for a prescription medicine will state that the medicine has provisional approval.

The PI provides health professionals with a summary of the scientific information relevant to the safe and effective use of a prescription medicine, while the CMI provides information about the medicine for patients and consumers.

You can find the Consumer Medicine Information and Product Information documents by searching the TGA website or on the relevant drug company’s website.

All provisionally approved medicines are included in the Black Triangle Scheme, as are other new medicines. This means that you will see a black triangle symbol on the PI and CMI. This does not mean that there are known safety problems with the medicine. The black triangle is a reminder to report side effects to help us build up the full picture of the medicine’s safety profile.

For a list of prescription medicines that are eligible for provisional approval, please see Prescription medicines determination and designation notices.

Report all side effects

Because data about provisionally approved medicines is still being collected, it is very important for both patients and health professionals to report all side effects.

Report all side effects directly to the TGA through our online form.

Subsidised medicines through the PBS

Subsidies are determined and administered by a different section of the Department. For more information about how prescription medicines are subsidised visit the Department of Health’s Pharmaceutical Benefits Scheme webpage.