A new paper, Strategic insights to reignite PMTA confidence: Reduce costs and protect timelines whilst continuing to innovate, has been published by analytical testing and scientific consultancy Broughton. Authored by Dr. Nveed Chaudhary, Paul Hardman, and Libby Clarke, the paper discusses five years of combined learnings from compiling major PMTA applications, including for products that have been granted marketing orders.
The paper highlights the ability to employ a keystone strategy to create multiple PMTAs from only a few datasets, allowing the reuse of significant data from one submission to support another. Illustrating that through innovative strategies, the reuse of up to 50% of data can be achieved.
It also highlights the benefits of employing close collaboration across PMTA modules. Showcasing that close collaboration between chemistry and toxicology experts when designing elements of Modules 3 and 4 can reduce testing costs by up to 60% and help build a more comprehensive product assessment.
“With experience across multiple PMTAs, we see that following a more holistic approach across the different PMTA Modules rather than treating them as individual silos helps create a more cohesive narrative that illustrates deeper levels of product understanding,” said Dr.
Nveed Chaudhary, Chief Scientific and Regulatory Officer at Broughton. “Currently, it is our opinion that as much as 80% of the data used for a PMTA could be repurposed for medicinal marketing authorization (MAA) in the UK if designed intentionally for both a PMTA and UK MAA, and vice versa.”
To read the paper in full, Click Here.