ABSTRACT
Government regulations exert a profound influence on the pharmaceutical industry. Virtually every aspect of drug development and marketing is affected by government oversight, which is initiated to protect citizen consumers. Ensuring the safety, efficacy, and quality of medicines is the primary focus of national drug regulatory policies. Stringent review procedures govern each step toward obtaining marketing authorization and require extensive product testing before commercialization. Another set of rules center on postmarketing safety surveillance, resulting in programs for systematic monitoring of adverse effects and enforcement mechanisms to correct product problems. A third category of regulations
addresses quality control issues in medical product manufacturing and testing facilities.
