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Across Europe, regulatory organisations are responsible for ensuring that medicines meet the three essential standards of efficacy, safety and quality.1 2 Evaluating the efficacy and safety of a medicine is a complex process that takes into account the nature of the active ingredient, the dose and duration of treatment, the disease or condition and patient factors.3 Typically, a medicine must be shown to be more effective than placebo. However, at the time that marketing authorisation is granted, there may be limited long-term data. Furthermore, highly selected participants in clinical trials may not fully represent the wider population of patients who will receive the drug in routine clinical practice. Safety considerations include the nature of the illness for which …
Competing interests None declared.
Provenance and peer review Commissioned; externally peer reviewed.
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