23 May 2016 - The report notes submission dates; a TGA first.

The publication of submission dates means TGA assessment/approval timelines can now be compared with those of other regulatory agencies such as the FDA (US), EMA (EU) and TPD (Canada).

An interesting example is the assessment of pembrolizumab (Keytruda) for malignant melanoma.  Keytruda was registered by the FDA on 4 September 2014; the assessment took 189 days.  The TGA received the dossier for pembrolizumab on 6 August 2014;  it was registered 253 days later on 16 April 2015 (ARTG start date).  The TGA registered pembrolizumab before the European Commission (17 July 2015) and Health Canada (19 May 2015).

The TGA annual report is yet to be posted on the TGA website. The TGA is yet to publish an AusPAR for Keytruda.