Setting the scene — the role of regulation
The regulation of medicines by society is time-bound, country-bound, and person-bound.
The most ancient function of regulation has been to ensure that a medicine’s label accurately describes its content, both qualitatively and quantitatively.
In modern times, regulation has dealt increasingly with assessments of the safety and efficacy of medicines.
Regulatory requirements have changed over time and must keep changing in accord with scientific progress and cultural values.
KeywordsRegulatory Agency Therapeutic Area Promotional Effort Clinical Trial Methodology National Medical Association
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