Pharma Worried Over Implementation of EMA's Traceability Requirements For Biologicals
EU pharmaceutical companies believe that batch traceability and product identification requirements in the European Medicines Agency's recently-finalized guideline on pharmacovigilance of biological medicines does not take into account the realities and practicalities of marketing such products.
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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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