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Drug Regulatory Agencies from Australia-Canada-Singapore-Switzerland (ACSS) Consortium Generic Medicines Working Group met in Seoul, South Korea, to advance work sharing arrangements in the assessment of generic drug applications
The ACSS Consortium Generic Medicines Working Group, comprising representatives from the drug regulatory agencies of Australia, Canada, Singapore and Switzerland, met on the 30th and 31st October 2015 in Seoul, South Korea ahead of the 2nd meeting of the International Generic Drug Regulators Programme (IGDRP), to advance information and work sharing arrangements in the assessment of generic drug applications.
The main focus of discussion in Seoul was the proposed ACSS Consortium Generic Medicines Work Sharing Trial (GMWST). The ACSS Consortium GMWST has been modelled on the European Union DCP and it is expected that this trial will accept a single application, simultaneously submitted in preferably three or four of the participating agencies. The process steps for this trial were discussed and finalised. The experience gained from undertaking this trial is expected to support regulatory decision-making within each jurisdiction and inform future work sharing initiative.
As part of the discussion relating to the ACSS Consortium GMWST, the four agencies acknowledged the importance of pro-active engagement with their respective generic industry associations and other stakeholders to facilitate the timely availability of safe, effective and quality generic drugs.
At this meeting the parties took the opportunity to exchange their views and experiences about the successful completion and implementation of a number of technical documents that are integral for the assessment of generic drug applications, such as the development of common tools to be used during the assessment of the generic applications.
The four agencies also discussed a list of technical matters of interest related to Module 3 data and bioequivalence. The discussion is important for regulatory convergence at the global level, particularly in the areas of quality and bioequivalence, which in turn will advance work sharing arrangements in the assessment of generic drug applications across multiple jurisdictions.
The ACSS Consortium Generic Medicines Working Group meeting concluded with preparations for the meeting of the International Generic Drug Regulators Programme (IGDRP) which was held from 4-5 November 2015, in the same city.
The next face-to-face meeting of the ACSS Consortium Generic Medicines Working Group is scheduled to take place in May 2016 in Strasbourg, France, in the margins of the 3rd IGDRP meeting.