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New horizons in pharmaceutical regulation.
Alasdair Breckenridge1, Michelle Mello, Bruce M Psaty
1Medicines and Healthcare products Regulatory Agency, London SW1W 9SZ, UK.
Nature Reviews. Drug Discovery
|June 30, 2012
Summary
A new approach to pharmaceutical regulation is emerging in the US and Europe. This method involves continuous assessment of drug safety and effectiveness after market approval.
Area of Science:
- Pharmacovigilance and Regulatory Science
- Drug Safety and Effectiveness Evaluation
Background:
- Traditional pharmaceutical regulation focuses heavily on pre-market approval.
- Post-market surveillance has historically been less integrated into the core regulatory framework.
Purpose of the Study:
- To describe the emerging life cycle approach to pharmaceutical regulation.
- To highlight the continuous assessment of benefit-risk balance for drugs post-approval.
Main Methods:
- Review of current regulatory trends in the United States and Europe.
- Analysis of the integration of post-market data into regulatory decision-making.
Main Results:
- A life cycle approach is gaining traction in major regulatory bodies.
- This approach emphasizes ongoing evaluation of drug benefit-risk profiles.
Conclusions:
- Continuous benefit-risk assessment post-approval represents a significant evolution in pharmaceutical regulation.
- This evolving framework aims to enhance post-market drug safety and public health protection.
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