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
At Asphalion we can help you register new prescription medicines!
For further information, you can send us an email at: info@asphalion.com
