ICMRA to launch several regulatory pilot programs centered around manufacturing inspections
As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.
ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.
These pilots will explore the potential for collaboration between regulators when it comes to specific data expectations and assessment approaches when assessing manufacturing facilities for PAIs and PLIs as well as reviewing PACs and PAC management protocols. Each pilot will last roughly 1 to 1.5 years, and will involve two or more regulatory authorities that will conduct three assessments or inspections.
“ICMRA recognizes that development, manufacture, and supply of medicines is now global, and a more global regulatory pharmaceutical quality knowledge management (PQ KM) capability would improve regulators’ ability to readily share and utilize the information that may already be received or collected. This includes information on manufacturing facilities, products, marketing authorization applications, and marketing application holders,” ICMRA said in a statement.
The other pilots focus on both collaborative assessments of CMC-related post-approval changes and hybrid inspections.
According to the organization, the main objectives of the two pilots include “the development of an initial common framework for collaborative assessment and hybrid inspections,” and identifying “best practices and standards in the quality assessment of CMC-related post-approval changes and collaborative hybrid inspections to inform relevant quality assessments.”
Another main goal is to develop recommendations for a “future cross-regional pathway(s) to be pursued by ICMRA.”
A report summarizing these programs will be published in 2023.