United States and European Union data on orphan drug regulatory activity from 1 January 2011 to 31 December 2023. The dataset was created by Jin Ding from FDA and EMA/EC records, focusing on FDA orphan approvals as the study cohort. It includes variables for EMA designation, marketing authorization, sponsor size, location, period, and therapeutic area.
Use Cases
- Analyzing discordance in orphan drug approvals based on EMA orphan designation status and EMA marketing authorisation status.
- Comparing regulatory outcomes across time periods based on the period variable (2011-2016, 2017-2023).
- Investigating the role of sponsor size and location in approval patterns based on sponsor size and HQ location.
- Examining differences in regulatory pathways between cancer and non-cancer therapies based on therapeutic area classification.
Strengths
- Data covers a 13-year period from 2011 to 2023.
- Sources are authoritative regulatory bodies: the U.S. FDA and the European EMA/EC.
- The final analytic dataset includes multiple categorical variables for analysis, such as sponsor size and therapeutic area.
Limitations
- Row count is unknown, which may limit suitability assessment.
- Column-level documentation is absent; field semantics must be inferred after download.
- The dataset is small (47.1 KB), indicating a limited scope.
Provenance
- Source
- U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)/European Commission (EC) records.
- Collection Method
- Extracted from orphan designation and approval records and authorization documents.
- Time Range
- 2011-01-01 to 2023-12-31
- Freshness
- Last updated 2026-06-04 07:38:14; freshness should be verified.
- Geography
- United States and European Union