The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on Project Orbis and the Access Consortium.
Project Orbis is a project coordinated by the US Food and Drug Administration (FDA) to review and approve promising cancer treatments and involves the regulatory authorities of Australia, Canada, Singapore, Switzerland, Brazil and the UK.
The Access Consortium comprises of the national regulatory authorities of Australia, Canada, Singapore and Switzerland and includes the following working groups:
- New Active Substances Working Group,
- Generic Medicines Working Group,
- Biosimilars Working Group,
- Complementary Health Products Working Group,
- Collaboration on International Council for Harmonization (ICH) Working Group, and
- IT Architecture Working Group.