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ACSS public statement, 29-30 October 2018

ACSS Generic Medicines Working Group

5 April 2019

On 29-30 October 2018 the ACSS Consortium Generic Medicines Working Group (GMWG) met in Canberra, Australia, to advance information and work sharing in the field of generic drug applications.

The focal point of the discussion was to review the response from industry to the ACSS Generic Medicines Work Sharing Trial (GMWST).

To this end the Working Group agreed to:

  • Seek further feedback from industry and peak organizations on the current response rate to the GMWST from prospective applicants; and
  • Seek feedback from peak organizations on the current response rate to the GMWST.

It was decided that the GMWST should remain open to new applicants, but that the GMWG would not to do any further work to progress the GMWST at this stage.

On Quality topics, the GMWG members discussed the draft versions of the Guidance for Quality Assessors - Drug Product and a common Quality Assessment Report (QAR) template for Drug Products and agreed to finalization once they had been revised.

During the meeting, the Guidance for Bioequivalence Assessors was discussed and it was agreed that it would be revised.

Specific technical issues of interest and mutual areas of concern, such as the use of foreign assessment reports, were discussed with the aim to facilitate work sharing arrangements in the assessment of generic drug applications among the ACSS Consortium members.

The next face-to-face meeting of the ACSS Consortium GMWG is expected to take place in May 2019.