I was at the TGA website reading up on provisional approvals and saw this: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.
It looks encouraging to me, but regarding the sentence I have in BOLD font, this suggests we would need the FDA approval first to satisfy this requirement, no? Because until the FDA say yes, how can we demonstrate that we can produce the additional data?
I was at the TGA website reading up on provisional approvals and...
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