Biological Quality In The Spotlight As UK MHRA Consults On Standard-Setting
Executive Summary
Quality standards for biological medicines are in the spotlight again, with the UK medicines regulator, the MHRA, in the midst of consulting stakeholders on how to ensure that publicly available monographs are suitable for biologicals in the future.
You may also be interested in...
UK MHRA To Explore Innovative Ways Of Setting Quality Standards For Biological Medicines
The UK MHRA has analyzed the responses to a consultation on its proposed strategy for developing pharmacopeial standards for biological medicines and says it now plans to work more closely with stakeholders to look at unmet needs, new innovative approaches to standard-setting, and build closer relations with other organizations at home and abroad.
Feel The Quality: Biosimilars Dominate Standards Setting Debate In EU
The quality issues that the European Medicines Agency considers when it evaluates biosimilar medicines became clearer during a recent event held in Strasbourg, France, where delegates also learned more about the role of European Pharmacopoeia monographs in ensuring the quality of biosimilars.
Feel The Quality: Biosimilars Dominate Standards Setting Debate In EU
The quality issues that the European Medicines Agency considers when it evaluates biosimilar medicines became clearer during a recent event held in Strasbourg, France, where delegates also learned more about the role of European Pharmacopoeia monographs in ensuring the quality of biosimilars.