Registries supporting new drug applications

Area of Science:

• Pharmacovigilance
• Drug Safety
• Regulatory Science

Background:

• Knowledge gaps regarding new drug benefits and risks persist post-marketing approval.
• Post-approval data collection through registries is essential for comprehensive drug evaluation.
• The European Union (EU) utilizes regulatory mechanisms to gather additional data on newly approved medications.

Purpose of the Study:

• To review the frequency, type, and rationale for requiring post-approval registries for new drugs approved in the EU between 2007 and 2010.
• To analyze the characteristics of drugs for which registries were mandated.

Main Methods:

• Systematic review of European Public Assessment Reports (EPARs) for drugs approved by the European Medicines Agency (EMA).
• Categorization of drugs based on therapeutic area (ATC1), level of innovation, and procedural characteristics.
• Classification of registries as disease-specific or drug-specific.

Main Results:

• Registries were identified for 43% of 116 new drugs approved during the study period, totaling 73 registries.
• The majority (46) were disease registries, while 27 were drug registries.
• Higher levels of innovation and orphan drug status were significant predictors for requiring post-approval registries.

Conclusions:

• Post-approval registries are a common regulatory tool, particularly for innovative and orphan drugs.
• Existing disease registries are frequently leveraged for post-approval data collection.
• Registries play a vital role in enhancing the understanding of drug safety and effectiveness after market entry.