What is it about?
The article identifies ten pillars that characterise strong regulatory review systems and are hallmarks of success in mature regulatory agencies and which can also benefit countries with less mature review systems. The focus is on practical actionable aspects which complement existing technical guidance harmonisation and the WHO's global benchmarking tool.
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Why is it important?
Pharmaceutical regulation of medicines is complex and there are many global initiatives to strengthen regulatory systems in fragile healthcare settings. A lot of very helpful technical guidance exists but there seemed to be a gap on what other types of practical steps agencies could take that would improve the efficiency of regulatory reviews and benefit patients. We aimed to fill this gap by giving a perspective from a multinational company on the ten most important features.
Read the Original
This page is a summary of: Building a Better Approach for the Benefit of Patients: 10 Pillars to Strengthen Regulatory Review Systems Globally, Therapeutic Innovation & Regulatory Science, March 2019, SAGE Publications, DOI: 10.1177/2168479019834529.
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