The Generic Medicines Working Group (GMWG) was established in 2012 with a specific focus on issues relating to generic medicines. The four regulatory agencies share the same desire to work with trusted, like minded regulators, adopt harmonised standards and share successes of existing models for collaboration in order to meet the challenges of global issues.
The GMWG aims to:
- Create opportunities and benefits for regulatory programmes through:
- Greater alignment of regulatory approaches and technical requirements
- More efficient use of resources through information and work sharing
- Establishment of an effective network among trusted, like-minded regulatory authorities;
- Produce immediate and ongoing results in priority work areas; and
- Serve as a “proof of concept” for other international regulatory cooperation initiatives.
Generic Medicines Work Sharing Trial (GMWST)
The Generic Medicines Work Sharing Trial (GMWST) is an innovative work sharing model for the coordinated assessment of a generic application that has been filed with multiple ACSS Consortium agencies. Its goals are to harness efficiencies in the registration process, promote regulatory convergence of technical data requirements, build confidence between agencies and provide data to be used for the development of a ‘business as usual’ work sharing arrangement.
Please refer to the following documents for more details on GMWST and how to apply.
- GMWST Notice to Applicants
- GMWST Operational Procedures;
- GMWST Expression of Interest Form (Word version); and
- GMWST Question and Answer Sheet.
Meetings and Communications
The GMWG meets bi-annually and also holds regular teleconferences to advance the work. For more information about the proceedings and notable outcomes from the face-to-face meetings, please refer to the Public Statements:
- 14-15 May 2018, Bern, Switzerland
- 27-28 October 2017, Brasilia, Brazil
- 1-2 June 2017, Ottawa, Canada
- 14-15 October 2016, Mexico City, Mexico
- 6-7 May 2016, Strasbourg, France