The TGA have just approved the first medicine via the provisional approval pathway (17th July, 2019) for Pembrolizumab (KEYTRUDA). First provisional approval | Therapeutic Goods Administration (TGA)… This is a major milestone and will, no doubt, encourage other companies to consider filing this way in Australia. What is Australia’s ‘Provisional Approval Pathway’? As part of […]
Medsafe NZ has now released a consultation document on the proposed Therapeutic Products Regulatory Scheme.