As regulators look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.
The ICMRA, which is made up of the world’s largest drug regulators, is launching several pilot programs, including two regulatory pilots involving inspections of facilities for Chemistry and Manufacturing Controls (CMCs) and assessments of drug submissions. Post-Approval Amendments (PACs) and related regulatory actions.
These pilots will explore the potential for regulators to collaborate on 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 project will last approximately 1 to 1.5 years and will involve two or more regulatory authorities carrying out three assessments or inspections.
“ICMRA recognizes that the development, manufacture and supply of medicines is now global, and a more comprehensive pharmaceutical regulatory quality (PQ KM) knowledge management capability would improve the ability of regulators to easily share and use knowledge. information that may already be received or collected. This includes information on manufacturing facilities, products, marketing authorization applications and marketing application holders,” the 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 the identification of “best practices and standards in quality assessment CMC-related post-approval changes and collaborative inspections”. hybrid inspections to inform relevant quality assessments.
Another main objective is to develop recommendations for a “future inter-regional path(s) to be followed by ICMRA”.
A report summarizing these programs will be published in 2023.