The vast resource drain that the current post-approval change regulatory situation globally is creating on both industry and regulators is in sharp relief at public venues where the future of pharmaceutical quality regulation is being discussed.
With the ICH Q12 effort opening the door on a more efficient and improvement-friendly post-approval change paradigm, hard light is being shed on the full dimension of the problem and the stakes in finding an international approach with enough power to address it.
The adage that a problem can only be dealt with when clearly understood is motivating the pharmaceutical community to forcefully articulate the resource drain and lost opportunity cost of the status quo.
The testimony that has been forthcoming, in turn, is compelling a deeper probing into how medicines could be regulated across their lifecycles in a way that would liberate technology and quality science to improve processes and products, lower costs and better assure patient availability.
Among the venues where this open dialogue about the post-approval change problem and how to address it has been occurring was a “manufacturing science workshop” held following the PDA/FDA conference at the end of September. [For more insights on the PAC regulatory issues, see the IPQ February 2014 Monthly Update.]