ACSS Consortium launches Generic Medicines Work Sharing Trial

To facilitate mutual interests in marketing authorisation applications for generic medicines, the ACSS Consortium has launched the Generic Medicines Work Sharing Trial (GMWST). The GMWST is a new work sharing model for the coordinated assessment of a generic application that has been filed with multiple ACSS Consortium agencies.

The ACSS Consortium is a collective initiative of harmonious, medium-sized regulatory authorities comprising of Australia’s Therapeutic Goods Administration (TGA), Health Canada (HC), Singapore’s Health Sciences Authority (HSA) and the Swiss Agency for Therapeutic Products (Swissmedic). The aim of this international information and work sharing consortium is to develop synergies and share knowledge, with the intended goal of improved health and safety benefits, as a result of enhanced effectiveness and efficiency of regulatory systems.

The trial will assess the practicalities of a coordinated assessment that will augment the regulatory decision-making within each jurisdiction. It has been suggested to set short timelines for the assessment of applications for this pilot to quickly acquire experience on potential opportunities with the work sharing trial and to inspire participation by applicants.

Applications for this trial should simultaneously be submitted to at least two or more of the ACSS Consortium members. Assessment reports will be prepared by the lead agency, known as the “Reference Regulatory Agency (RAA)”, following the complete review of the dossier. The other agencies involved will act as the “Concerned Regulatory Agencies (CRAs)” and perform a peer review of the assessment reports and the application, provide supplementary comments.

The trial provides a unique opportunity for a global collaboration between the pharmaceutical industry and regulatory authorities. A reduction in regulatory burden (for example, with the filing of common dossiers), more timely regulatory decisions, concurrent marketing authorisations to multiple markets and opportunities to support advancing regulatory modification are some of the possible benefits for the pharmaceutical industry.

The knowledge gained through carrying out this pilot will “inform internal procedures on the effective use of foreign assessment reports as well as collaborative work with international regulatory partners.”

To read more about the GMWST and to view the documents associated with it, please click here.