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.
Perspectives
In writing this article we drew on the experience within our company at a global, regional and country level across many different product portfolios. We had some interesting debates on which features should and should not make our top ten. We certainly do not claim to have all the answers and we realise that this is just one perspective. We hope that by putting our viewpoint out there that this may stimulate debate and enable progress in this area.
Judith Macdonald
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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