Snapshot

The Promise Pilot Pathway: ACCESS New Active Substance Work-Sharing Initiative (NASWSI) pathway has been developed by the of ACCESS Worksharing Program.

This pathway can be used where NME's (small molecules), Biologics/vaccines.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: Australia Canada Singapore Switzerland United Kingdom

Interested applicants should submit their EoI at least 6 months before filing their application for marketing authorization. The Access agencies understand that an applicant may not know until closer to submission that their application is suitable for priority. Where this is the case, applicants are encouraged to discuss the timelines with the proposed agencies and/or to submit an EoI 6 months before filing and note that they may withdraw their interest in the Promise Pilot pathway pending the outcome of ongoing clinical trials. 1) Determining eligibility for the pathway - Expressions of interest for new active substances must meet the following criteria: • 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. After receiving the EoI, participating agencies will determine whether the eligibility criteria have been met and, if so, send a confirmation to the applicant. A lead agency is then determined. The applicant and all agencies proposed for work-sharing may wish to hold a joint pre-submission meeting/teleconference (combined logistical and technical). Applicants should propose possible meeting dates in their EoI form. 2) Evaluating a priority review request - For eligible EoIs, Access agencies will assess the evidence of a significant therapeutic benefit to determine whether to grant priority review status. One agency will lead the assessment and peer review will take place by all agencies, with work being shared between the agencies. The agencies will then seek to reach a consensus regarding the application’s priority review status through the Promise Pilot pathway, however, in principle, an agency may still consider its national criteria for priority review/fast-track requests as part of its decision. Applicants may refer to each jurisdiction for more information. However, those national criteria are very similar and allow the applicant to prepare 1 data package, which is submitted to all jurisdictions. If the Access agencies cannot agree, the applicant may continue to submit the application using the: • Promise Pilot pathway for those agencies that accepted the request or • standard Access procedure to all requested agencies. If priority review status is not granted, an applicant cannot use the Promise Pilot pathway. An applicant may still submit a national priority/fast-track request or a national reconsideration application, where applicable. Note: There are no legal entitlements or appeal rights for the Promise Pilot pathway, as Access procedures are proposed in addition to national procedures. Target timeframes for pathway – calendar days (Key dates only): 25 days for screening of application, day 180 = separate sovereign decision. Evaluation plans are always discussed with an applicant in advance.