Design and Development of National Drug Regulatory System and Policies

Abstract

Regulation of drugs encompasses a variety of functions. Key functions include licensing, inspection of manufacturing facilities and distribution channels, product assessment and registration, adverse drug reaction (ADR) monitoring, QC, control of drug promotion and advertising, and control of clinical drug trials. Each of these functions targets a different aspect of pharmaceutical activity. All of these functions must act in concert for effective consumer protection. Quality of drugs available to the public is the main aim of drug regulation. If regulatory goals are to be achieved, appropriate structures must be established and appropriate activities carried out to achieve the desired goals. Comprehensive and up-to-date laws, unified but independent organization, competent human resources, freedom from political and commercial influence, adequate and sustainable financial resources, clear and transparent standards and procedures, outcome-oriented implementation and systematic monitoring and evaluation are critical components contributing to effective drug regulation.