ACCESS CONSORTIUM | New Promise Pilot Pathway

The Access Consortium is a collaborative initiative between five Health Authorities: Australia’s Therapeutic Goods Administration (TGA), Health Canada (HC), Singapore’s Health Sciences Authority (HSA), the Swiss Agency for Therapeutic Products (Swissmedic) and the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK. It intends to build synergies and maximize international cooperation to ensure patients’ timely access to safe therapeutic products in the member countries.

The Access Consortium is a collaborative initiative between five Health Authorities: Australia’s Therapeutic Goods Administration (TGA), Health Canada (HC), Singapore’s Health Sciences Authority (HSA), the Swiss Agency for Therapeutic Products (Swissmedic) and the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK. It intends to build synergies and maximize international cooperation to ensure patients’ timely access to safe therapeutic products in the member countries.
December 18, 2023

The Access Consortium working group for new active substances has established an aligned process for priority review, which includes the decision on priority status.

In creating the Promise Pilot Pathway, the Access partners (Australia, Canada, Singapore, Switzerland and the UK) sought commonality in their respective criteria for priority review. Applications for new active substances fulfilling the following criteria are eligible for the Promise Pilot Pathway:

  • Diagnoses, treats or prevents a condition that is serious, life-threatening or severely debilitating and
  • For which no other treatment is currently registered and marketed in participating jurisdictions for the proposed indication

 

The scope of the Promise Pathway will be further reviewed after the pilot.

Please find more details in the newly published Operational Procedures: OPERATIONAL PROCEDURES

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