Access Consortium Generic Medicines Working Group: Mandate

On this page

• Purpose
• Background
• Objectives of working group
• Scope of work
• Meetings/communications
• Contact information

Purpose

The purpose of this page is to share a common understanding of the objectives and the operations of the Access Consortium's Generic Medicines Working Group (GMWG).

Background

The Access Consortium (formerly the ACSS Consortium) was formed in 2007 by 4 regulatory authorities:

• Canada's Health Canada (HC)
• Singapore's Health Sciences Authority (HSA)
• Australia's Therapeutic Good Administration (TGA)
• Switzerland’s Agency for Therapeutic Products, Swissmedic (SMC)

The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) joined the Access Consortium in 2020.

Each agency shares similar challenges such as increasing workload, complexity of issues relating to medicinal products and pressure on available resources.

The Access Consortium is under the leadership of the heads of agencies of the participating regulatory authorities.

Objectives of working group

The Access Consortium's Generic Medicines Working Group (GMWG) focuses on issues relating to generic medicines.

To meet the challenges of global issues faced by regulators and industry, the 5 regulatory agencies share the desire to:

• adopt harmonized standards
• work with trusted, like-minded regulators
• share successes of existing models for collaboration
• ensure regulatory technical requirements are similar

The GMWG aims to:

• produce immediate and ongoing results in priority work areas
• create opportunities and benefits for regulatory programs 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
• serve as a “proof of concept” for other international regulatory cooperation initiatives

Scope of work

The GMWG undertakes a range of activities. These include:

• serve as a model for other collaborations among regulatory authorities
• create efficient work-sharing arrangements for the 5 Access Consortium members
• share best practices and lessons learned on issues related to the regulation of generic medicines with:
  • Access Consortium members and with broader, multilateral collaborative initiatives
• support and inform the efforts of the International Coalition of Medicines Regulatory Authorities to develop global information and work-sharing approaches
• support the development of secure IT platforms and solutions to enable effective mechanisms for information and work-sharing initiatives

The GMWG has implemented the Generics Medicines Work Sharing Initiative. This group assesses applications submitted at the same time in 2 or more of the participating regulatory agencies. 

The goals of this work-sharing initiative are to:

• build confidence between agencies
• harness efficiencies in the registration process
• develop a ‘business as usual' work-sharing arrangement
• promote regulatory convergence and harmonization of technical data requirements

The work-sharing initiative also dedicates resources to perform robust assessments by providing the appropriate level of regulatory oversight.

Meetings/communications

The GMWG holds regular teleconferences and may meet face to face periodically to advance priority initiatives.

Contact information

• Canada: collaboration@hc-sc.gc.ca
• Singapore: hsa_tp_enquiry@hsa.gov.sg
• Switzerland: networking@swissmedic.ch
• United Kingdom: access-mhra@mhra.gov.uk
• Australia: pmabinternationalevaluations@health.gov.au