Pharma Worried Over Implementation of EMA's Traceability Requirements For Biologicals
Executive Summary
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.
You may also be interested in...
EU Regulators Ramp Up Safety Monitoring Efforts For Biologicals
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.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.