The last 30 years has brought significant changes to self care through responsible self medication. From being essentially unregulated in the 1960s, over-the-counter (OTC) medicines have been transformed by the evolving statutory and regulatory initiatives into a mature market with a high level of consumer confidence in their safety and expected benefits. This paper reviews the legislative/regulatory achievements that have modernized self care with OTCs, including the statutory and regulatory basis for OTCness, the criteria and studies used as a basis for permitting OTC availability, and the paradigm for interaction between regulators and sponsors, as well as the challenges still facing the industry.
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