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EU Regulators Ramp Up Safety Monitoring Efforts For Biologicals

This article was originally published in SRA

Executive Summary

It is well known that biological medicinal products are different from chemically synthesized medicines and that these differences are recognized in terms of the data required to support their evaluation. Regulatory authorities are now ramping up efforts to produce dedicated programs and guidance to support the pharmacovigilance of biologicals, reports Vibha Sharma.


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