The pilots are being operationalized under the auspices of ICMRA to explore the feasibility and potential for further collaboration and convergence among regulators in specific data expectations and assessment approaches when assessing manufacturing facilities for Pre-Approval and Pre-License Applications (PAIs & PLIs) and reviewing PACs and PAC Management Protocols.
The two pilots, one focused on collaborative assessments of CMC submissions, and the other on hybrid inspections, are to inform pre-market or PAC CMC assessment of drug applicants. Each of the pilots will involve two or more National Regulatory Authorities collaborating in the effort. Please note that the actual post approval change submission should follow the normal regulations and procedures in each participating region.
Each pilot aims to conduct three assessments or collaborative hybrid inspections over an anticipated duration of 1-1.5 years, and then issue learnings and recommendations on how to operationalize these programs in the future to benefit Industry and Regulators.
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