Having satisfied itself that it has in place a reliable system of premarket evaluation, the DRA must ensure that the standards required are maintained. As far as resources allow, postmarketing activities should include:
• Review of applications to vary authorized products;
• Random audits of notified variations (see Annex 10);
• GMP inspections of local manufacturers;
• Quality control laboratory testing of samples selected randomly;
• Quality control laboratory testing of samples suspected to be substandard;
• Monitoring of adverse drug reactions;
• Monitoring of advertising and other promotional activities;
• Promotion of rational drug use;
• Monitoring of the implementation of the regulatory component of the national drug policy;
• Drug utilization studies.
Priorities within this list may vary in different countries.