Registration of antidepressant drugs — views of a regulatory agency

Abstract

The prime objective of a national drug policy is to provide the community with reasonably priced, safe and efficacious drugs of high pharmaceutical quality. To achieve this objective, a number of regulatory activities have to be carried out constantly, among which are: inspection of pharmaceutical plants and laboratories; analytical and biological control; assessment of clinical trial protocols and safety documentation; assessment of new drug applications (NDAs); post-marketing surveillance, including drug promotion activities; drug consumption surveys; drug prescribing patterns; and adverse reaction reporting. Society expects its drug regulatory agency to take actions promptly whenever a drug hazard is identified. Similarly, it expects the introduction of new valuable drugs with the minimum of delay caused by the regulatory handling of the application.