Last month the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) released the first set of conclusions from a programme - launched in March 2011 – assessing, in parallel, quality-by-design (QbD) elements of marketing-authorisation applications (MAAs).
Whilst the two agencies agreed on a number of matters - including requiring the manufacturing description to be of the same detail regardless of approach – the pilot still demonstrated the EMA and FDA have differences, said Dr. Brij Patel, a consultant at RegExcel Consulting.
Firstly, “the programme showed that the agencies had differences in interpretation of certain ICH principles,” Patel, a former Assessor at the MHRA, told in-Pharmatechnologist.com.
“There was also a significant difference in the numbers of questions asked from the EU versus the US,” he continued. “The two regions did not have to come to the same conclusions and you could expect there were many discussions at each stage of the procedure where differences in the assessment were identified.”
However, Patel – who had experience with the pilot programme during his tenure at the MHRA – said “this type of interaction can only be healthy.
“Issues would have come up in 'regular' as well as QbD areas and this type of document gives information on joint QbD views - I would hope there would be a way to communicate and address differences in 'regular' assessment areas too.”
Conclusions from the Conclusions
Amongst the conclusions brought up in the EMA and FDA’s Q&As was that the Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) should be communicated to the Agencies, though not as a prerequisite for European ‘traditional’ applications.
“However, I think these are useful tools for communicating important aspects of the product, both within the company during development, and with agencies during key regulatory interactions,” said Patel.
He also commented on the pilot’s conclusion that companies cannot use a three tier classification for criticality of process parameters. However, in his experience, “mostly everyone was using a 3-tier system, even though the regulatory message had been clear for some time.”
Therefore results from the study mean “companies will now need to decide on where parameters in the 'middle tier' belong and produce the data or reasoning to support their classification.”