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IntroductionThe practice of pharmacovigilance revolves around patient safety by improving the benefit-risk balance of a pharmaceutical product. This is done by alleviating the extent of the adverse reaction associated with it or by enhancing its benefit. Routine minimization measures such as specific dosing regimens, warnings & precautions communication through labeling , patient follow-ups, relevant testing

The Eprex®-pure red cell aplasia case of 1998 engendered the understanding the perhaps the safety associated with biosimilars cannot be extrapolated from the innovator medicine as in the case of generics. Although generics and biosimilars are similar in the manner that they are both permitted for marketing only after expiry of the patent of the

The International Conference on Harmonization of Technical Requirements for the registration of pharmaceuticals for human use, or the ICH, was formed to facilitate harmonization of requirements and procedures among member states to ensure safe, efficacious, and high-quality drugs reach the market. The founding regulatory members include the European Commission (EC) of Europe, the Food and

Overview Pharmacovigilance (PV) and post-market surveillance is important to capture the safety profile of a drug. The entire information on a benefit-risk ratio & safety profile is not known until or unless the drug has reached the market and been used in a larger, much wider population. Hence, a systematic approach in monitoring and evaluating