Drug Regulations, Acts, and Legal Framework
Pharmacovigilance and Post-Marketing Surveillance
Pharmacovigilance is crucial for post-marketing drug surveillance, ensuring the safety and efficacy of medications through legal frameworks and regulations.
Drug Regulations, Acts, and Legal Framework
Pharmacovigilance and Post-Marketing Surveillance
Ensuring drug safety is a fundamental aspect of healthcare and regulatory agencies worldwide. The process does not stop after drug approval; continuous monitoring, known as pharmacovigilance, is essential to track adverse effects and safeguard public health.
What is Pharmacovigilance?
Pharmacovigilance refers to the activities aimed at detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. Regulatory bodies like the FDA, EMA, and CDSCO require pharmaceutical companies to report adverse drug reactions (ADRs).
Key Regulations and Acts
- FDA Drug Safety Regulations: The US FDA monitors drugs post-approval through the MedWatch program.
- EMA Guidelines: The European Medicines Agency (EMA) enforces the EudraVigilance system.
- India's Pharmacovigilance Programme: The Pharmacovigilance Programme of India (PvPI) is responsible for ADR reporting.
Post-Marketing Surveillance Strategies
Post-marketing surveillance involves the systematic collection and analysis of data related to drug effects in large populations.
- Spontaneous ADR Reporting Systems
- Observational Studies
- Electronic Health Record Monitoring
- Prescription Event Monitoring
Conclusion
Pharmacovigilance ensures continuous monitoring of drug safety, protecting patients from unforeseen risks. Regulatory frameworks must evolve to enhance drug safety surveillance.
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Drug Regulations, Acts, and Legal Framework
