23 January 2018 - The TGA's publication of registration milestone dates facilitates more meaningful international comparisons.
The TGA approved avelumab (Bavencio) on 3 January 2018 and glecaprevir with pibrentasvir (Maviret) on 2 January 2018. The results from an international comparison for these two medicines are presented below.
These results are less than ideal as the TGA is yet to publish submission dates; the date of the TGA's commencement of the evaluation of the submission has been used as a proxy for submission date.
Avelumab (Bavencio)
TGA - 3 January 2017 - 2 January 2018 = 364 days
FDA - 23 September 2016 23 March 2017) = 181 days
EMA - 6 October 2016 - 18 September 2017) = 347 days
Glecaprevir with pibrentasvir (Maviret)
TGA - 28 February 2017 - 21 December = 296 days
FDA - 14 December 2016 - 3 August 2017 = 232 days
EMA - 21 December 2016 - 26 July 2017 = 217 days