6 August 2016 - The TGA and EMA have recently described their experiences in publishing public assessment reports, and reflect on their future role in communicating medicines information.

The publication does not address timeliness with respect to openness and transparency.  The agencies need to consider the timeliness of the publication of information they hold that is in the public interest. EPARs are published soon after registration; the publication of an AusPAR often takes many months and at times, sometimes more than a year after registration.

A prime example here is pembrolizumab (Keytruda) for use by patients with unresectable malignant melanoma.  Keytruda was registered by the TGA on 16 April 2015 and registered by the European Commission on 17 July 2015.  The EPAR was published on 30 July 2015; the TGA is yet to publish an AusPAR.

It would be interesting to compare the publication timelines of EPARs & AusPARs for a representative cohort of new medicines.