14 January 2020 - According to the TGA, it approved 34 new chemical entities in 2019.

This total is somewhat favourable to the TGA given:

• It has counted its approval for acalabrutinib (Calquence) on 21 November 2019 for one use and the following day for another use as two new chemical entities. One could argue that its approval on 22 November 2019 is a new indication (just).
• It has deemed Vaxigrip Tetra (influenza vaccine (quadrivalent, split virion)) to be a new vaccine/chemical entity. The TGA approved other formulations of influenza vaccine (quadrivalent, split virion) in 2013, 2014, 2016 & 2018.
• It has deemed Fluad Quad (influenza vaccine (quadrivalent, adjuvanted)) to be a new vaccine/chemical entity.

The corresponding total for 2018 is 32.

The mean period from the date of the commencement of the TGA's evaluation of the submission (NOT the date of the submission) to the date of TGA (approval) (NOT the date of entry in the ARTG) for the 34 new chemical entities is 360 days.  The corresponding value for 2018 is 365 days.

Want more insights? Contact us for a more detailed analysis of the TGA in 2019.