Posted by Michael Wonder on 22 Jan 2018
Registration of new chemical entities in Australia
22 January 2018 - New year leads to improved transparency on regulatory dossier timelines; submission dates yet to be disclosed.
The TGA has published information on new prescription medicines containing new active substances it has approved so far this year. The TGA approved avelumab (Bavencio) on 3 January 2018 and glecaprevir with pibrentasvir (Maviret) on January 2.
For each medicine, the TGA has published the:
- Date of the registration decision (2 January 2018 and 21 December 2017, respectively)
- Date of the agency's commencement of the evaluation (3 January 2017 and 28 February 2017, respectively)
The TGA has not published the dates of the two submissions. This is disappointing and hard to fathom; the FDA (US), EMA (EU) and TPD (Health Canada) all publish submission dates.
MAESTrO will compare the registration timelines of these medicines in tomorrow's edition.
