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T 02: Practical Aspects of Developing, Implementing and Using Facilitated Regulatory Pathways (FRPs) in the Emerging Markets

Poster Presenter

Lawrence Liberty

Adjunct Research Professor, Reg Affairs and Quality Assurance Graduate Program
Temple University School of Pharmacy
United States

Objectives

To assess the characteristics and common elements of currently implemented expedited (facilitated) regulatory pathways (FRPs) in use by national regulatory authorities (NRAs) in emerging economies to accelerate access to important new medicines.

Method

We identified NRAs with FRPs through Cortellis Regulatory Intelligence and web sites and developed 27 FRP characteristics. The respective NRA or a local specialist reviewed author interpretations. Characteristics were procedural or substantive and based on five sequential regulatory activities.

Results

We assessed 33 FRPs from 29 countries. The regions with the most addressed characteristics (median number), were Middle East/North Africa (17) and Eastern Europe (17). Sub-Saharan African FRPs had the fewest characteristics addressed by their FRP (9). Consistent with the predominance of procedural characteristics in our categorisation scheme, all FRPs addressed at least twice as many procedural than substantive characteristics. The most commonly addressed procedural characteristics were having a standard operating procedure (SOP) or guidance for submitting the dossier and an SOP on how the dossier will be reviewed. The most commonly addressed substantive characteristic was whether the product must be used to treat a serious condition or where there is an unmet medical need. Of the 15 common characteristics, 11 were procedural and 4 substantive. A majority of FRPs provided opportunities for frequent interactions between the sponsor and agency’s review team. Of the 24 FRPs for which a review target time was defined, all but one had a target of 180 days or less and 54% had a target of 90 days or less. Post-approval commitment requirements in the form of post-authorization studies (78%) and risk management plans (67%) were often required.

Conclusion

Emerging economies are developing country-specific FRPs to accelerate approval of medicines for serious and unmet medical conditions. This poster presents recent analyses of the characteristics, diversity and best practices observed with 33 FRPs from 29 countries and how they can be optimally used to further engagement with emerging NRAs regarding their design and implementation. This study is a first step in describing common characteristics of FRPs from emerging NRAs. We observed diversity in regional FRP characteristics, suggesting a role for further engagement with emerging NRAs regarding the design and implementation of their FRPs. FRPs will have a meaningful role in accelerating access to important new medicines. Sponsors of marketing applications for products that may fulfil unmet, serious public health challenges should seek to interact early with the NRA to determine the current state of this dynamic field, and address the current requirements based on agency feedback. Based on these results and with further research and experience, we would hope to suggest FRP characteristics that could be successfully implemented by emerging NRAs.