26 May 2016 - The TGA claims it takes, on average, 12 months for the agency to register a new medicine.

The TGA 2015 Annual Report provides increases transparency around approval times and includes key dates in relation to the registration process for each medicine.

The TGA approved 35 new medicines in 2015.  The average time from the date of the receipt of a submission to the date of approval (assessment period) for these 35 medicines was 410 days (13.6 months).  The medicine with the longest assesment period was pralatrexate (1019 days); this is because the TGA rejected the initial dossier.  The medicine with the shortest assessment period was ibrutinib (189 days).  The assessment period for pembrolizumab was 252 days.