The Therapeutic Goods Administration (TGA) Australia are implementing a pathway for the provisional registration of prescription medicines, which is part of the Government’s response to the Review of Medicines and Medical Devices Regulation (MMDR review). Approval through the provisional pathway will be on the basis of preliminary clinical data where a substantial benefit is foreseen for Australian patients.
The provisional approval pathway is available to new prescription medicines or new uses for already registered prescription medicines, and the pathway consists of five steps: provisional determination, pre-market registration, the provisional registration period, extension of provisional registration and transition to full registration.
Provisional registration of prescription medicines through this pathway is limited to a maximum of six years on the Australian Register of Therapeutic Goods (ARTG). However the pathway aims to provide access to promising new medicines where the benefit of early availability of the medicine outweighs the risk which relates to the fact that additional data is still required. Sponsors may be able to apply for full registration when sufficient clinical data is collected which confirms the safety and efficacy of the medicine.
The eligibility criteria for the provisional approval pathway are: new prescription medicine or new indications medicine; treating a serious condition; favourable comparison against existing therapeutic goods; major therapeutic advance or evidence of a plan to submit comprehensive clinical data. The eligibility criteria helps to ensure that only medicines providing the most benefit to patients are provisionally approved. Furthermore, the criteria requires sponsors to demonstrate that they can provide additional clinical data to confirm safety and efficacy within the provisional registration period. Guidance on provisional determination eligibility criteria is available here.
Benefits of the provisional approval pathway include early access to prescription medicines, which could come to the market up to two years sooner than in the current framework, which provide a major therapeutic advance for Australians. The pathway also brings increased alignment with other overseas regulators that provide similar pathways.
Sponsors are strongly encouraged to organise a pre-submission meeting with the TGA to discuss planned applications for provisional determination.
To read more about TGA’s provisional approval pathway for prescription medicines, please click here.