Harmonising generics group

THE Therapeutic Goods Administration (TGA) has announced the matters discussed and actions taken by the AustraliaCanada-Singapore-Switzerland (ACSS) Consortium when they met in Brasilia, Brazil, on 27-28 Oct 2017.

The ACSS Consortium is a “medium sized coalition”, which was formed in 2007 by ‘like-minded’ regulatory authorities to promote greater regulatory collaboration and alignment of regulatory requirements.

It says its goal is to maximise international cooperation, reduce duplication, and increase each agency’s capacity to ensure consumers have timely access to high quality, safe and effective therapeutic products.

The purpose of this meeting was to advance information and work sharing arrangements in the assessment of generic drug applications with the focus of the meeting being the Generic Medicines Work Sharing Trial (GMWST).

The working group members discussed the continuation of the work-sharing trial and reviewed the draft article on experiences and lessons learnt from the first application.

In addition, the group discussed the publication of the GMWST documents on all of the ACSS agency websites to raise industry awareness of the trial and to encourage candidate applications.

Finally, the GMWST documents were updated, namely the Notice to Applicants, Operational Procedures, Questions and Answers and the Expression of Interest (EOI) form.

The ACSS Consortium GMWG also prepared a summary of its work for presentation at the 6th meeting of the IGDRP, which was held directly after the GMWG meeting, from 30 Oct to 02 Nov 2017 in Brasilia.

The next face-to-face meeting of the ACSS Consortium GMWG is set for 14-15 May 2018 in Bern, Switzerland.