Compare Submission Profiles Across Authorities — compare

Puts several regulatory authorities side by side so a sponsor filing in more than one region can see how the readiness bar differs: pillar weights, the score needed to be ready, the minimum traceability coverage, how many indicators are required, and the detectability default that feeds risk scoring. It answers "what changes if we also file with the EMA" without building and eyeballing each profile by hand.

Usage

compare_authorities(authorities = NULL, submission_types = NULL)

Arguments

authorities: Character vector of authority names, matched case-insensitively (for example c("fda", "ema", "pmda")). Defaults to every supported authority from list_authorities().
submission_types: How to pick a submission type per authority. NULL (default) uses each authority's first type. A single string uses that type for every authority (and errors if one does not offer it). A named vector (c(FDA = "NDA", EMA = "MAA")) selects per authority, falling back to the first type for any authority not named.

Value

A tibble with one row per authority and columns authority, full_name, country, submission_type, the four pillar weights (w_quality, w_trace, w_risk, w_usability), ready_min (lowest SCI in the ready band), minimum_coverage, n_required_indicators, default_detectability, and required_asset_types.

Examples

compare_authorities(c("FDA", "EMA", "PMDA"))
#> # A tibble: 3 × 13
#>   authority full_name           country submission_type w_quality w_trace w_risk
#>   <chr>     <chr>               <chr>   <chr>               <dbl>   <dbl>  <dbl>
#> 1 FDA       U.S. Food and Drug… United… IND                  0.3     0.25   0.3 
#> 2 EMA       European Medicines… Europe… CTA                  0.3     0.2    0.35
#> 3 PMDA      Pharmaceuticals an… Japan   CTN                  0.25    0.3    0.3 
#> # ℹ 6 more variables: w_usability <dbl>, ready_min <dbl>,
#> #   minimum_coverage <dbl>, n_required_indicators <int>,
#> #   default_detectability <int>, required_asset_types <chr>

# A specific submission type where all three offer it is not guaranteed, so
# select per authority:
compare_authorities(
  c("FDA", "EMA"),
  submission_types = c(FDA = "NDA", EMA = "MAA")
)
#> # A tibble: 2 × 13
#>   authority full_name           country submission_type w_quality w_trace w_risk
#>   <chr>     <chr>               <chr>   <chr>               <dbl>   <dbl>  <dbl>
#> 1 FDA       U.S. Food and Drug… United… NDA                  0.35    0.25   0.25
#> 2 EMA       European Medicines… Europe… MAA                  0.3     0.25   0.3 
#> # ℹ 6 more variables: w_usability <dbl>, ready_min <dbl>,
#> #   minimum_coverage <dbl>, n_required_indicators <int>,
#> #   default_detectability <int>, required_asset_types <chr>