2022 FRPath® Reliance Survey

FRPath® 2022 Annual Reliance ROI Survey

The second annual perception survey of the return on investment of the use of regulatory reliance pathways

Regulatory reliance pathways for marketing authorizations are playing a growing, important role in facilitating access to important medicines. Perceptions of their value and return on investment of time and effort (for both the agency and the sponsor) can vary. And identifying the drivers of their success remains a topic of study.

Please help the FRPath® project (a project of the non-profit Erudee Foundation www.erudee.org) learn more about how to optimize these pathways by participating in this simple anonymous 2-question poll. The more responses the better! Results will be posted here in LinkedIn and on the FRPath.org website following the close of data collection on December 31, 2022.

Question Title

* 1. Which of the following do you believe are the three most important drivers of the successful use of reliance pathways by a regulatory agency (select three):

Flexibility around the timing of submission of the CPP/eCPP

Acceptance of submission in eCTD format

Accepting documents in English language

Availability for pre-submission interactions between the company and agency

Clear published guidelines publicly available

Adherence to target agency and company accelerated timelines

Acceptance of redacted assessment reports from reference agencies

Being part of a regional regulatory consortium (eg CRS, APEC, Zazibona, GHC, EAC, ACCESS)

Agency willingness to train staff on novel regulatory approaches

Being members or observers of a regulatory harmonization initiative like ICH, PICS, IPRP

Trust in the processes of the reference agency

Having a sound legal basis for the use of reliance with publicly available guidances and procedures

Using a rolling review process

Other (please specify)

Question Title

* 2. What is your perceived overall return on investment (ROI) for the use of reliance pathways for marketing authorizations? If you have had experience with these, base your rating on that. If you have no experience, base your rating on your perceived expectation of the ROI of using reliance pathways. My perception rating of the ROI is [where 1= poor, 4= excellent]:

1 = Poor

4 = Excellent

Question Title

* 3. For categorization purposes only. Your primary affiliation:

Regulatory agency

Pharmaceutical company/ product developer

Academic/student

Consultant

Health technology Assessment

Other (please specify)

Question Title

* 4. Thank you for your response! We'd love to stay in touch by providing information about advances in the field of FRPs, upcoming FRPath webinars and updates in the FRPath database through our periodic FRPanorama e-Newsletter. By providing your contact information you agree to receive periodic updates from FRPath.

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