Promise Pilot Pathway: Access work-sharing for priority prescription medicine applications

We are advising sponsors, who are intending to register new prescription medicines, of a new way to pursue work-sharing for priority applications. 

The Access Consortium working group for new active substances has established an aligned process for priority review, which includes the decision on priority status. To facilitate the process for applicants, common timelines for the priority review request have been established, and the request is evaluated in a collaborative way, seeking a consensus decision.

In creating the Promise Pilot Pathway, the Access partners sought a common approach for their criteria for priority review. Applications for new active substances meeting the following criteria are eligible for the Promise Pilot Pathway. The application must be for a new active substance that diagnoses, treats or prevents a condition:

• that is serious, life-threatening or severely debilitating 
• 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: