Registration of new chemical entities in Australia (update)

TGA

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


Michael Wonder

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Michael Wonder