Before being placed on the market, the products go through rigorous testing and are developed through systematic scientific research. Only after an extensive review of studies in animals and data on safety and efficacy (pre-clinical tests) is that the drug passes through the phase of clinical research (phases I, II and III).
Even with the scientific rigor to clinical studies are conducted after approval the drug will win a much larger scale: millions of patients may use the drug in uncontrolled situations.
Hence the importance of pharmacovigilance: examining the risks involved with the use of the pharmaceutical product in "real world".
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