Access Consortium has released their Strategic Plan 2021-2024 in June 2021 to allow shareholders to learn more about the future the consortium envisions. This plan will guide the consortium towards enhanced efficiency of their national regulatory systems, while optimizing synergies and alignment among regulatory authorities and reducing duplication for industry.
The members of the Access consortium are Australia TGA, Health Canada, Health Sciences Authority of Singapore, Swiss medic and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
Access work-sharing initiatives have developed considerably and continue to grow. Since the first Access simultaneously reviewed submission in 2017, 12 medicine submissions have been evaluated; 16 medicines are under active review; and an additional 7 applications are in pre-filing planning.
Access intends to build on this success by continuing with work-sharing across multiple submission types for new active substances, biosimilars, and generics. The consortium intends to host joint pipeline meetings and provide scientific advice on development plans, including for cutting edge of advanced therapies.
The following are the strategic objectives for 2021-2024 to guide the Access Consortium in achieving its vision and mission.
- Strengthening Access work-sharing initiatives: Making Access a competitive and efficient submission pathway of choice for industry, supported by regulators
- Expanding lifecycle approach: Maximizing collaboration throughout the health product lifecycle
- Regulatory innovation that integrates a healthcare systems approach: Increasing regulatory capacity while collaborating with key national healthcare systems partners to facilitate uptake of innovative health products
More details at this link: https://www.tga.gov.au/australia-canada-singapore-switzerland-united-kingdom-access-consortium/