CRED Practical Document Writing and Management

What happens next...Health Authorities Desk

● Two elements to validation: 1 st validation - Technical

– Takes place once an electronic application is received at the Agency, ensuring the structure of the submission is compliant with the regional Module 1. – The submission is archived according to local regulations. A read only copy of the submission is then made available to the review community in the regulatory authority. This is typically done by placing the copy on a network server. – Each regulatory authority should acknowledge the receipt of the eCTD submission according to the policy and procedure of the individual regulatory authority, but Reg Ops will receive:-

CESP : - A New Submission File Name CESP_Submission_123456.xml has been uploaded to UK: MHRA EMA : - SUCCESS_ACK_EMA_H_C_001234_0001

Agencies will use different vendor validation tools, and may also use the Lorenz ‘esubmission management system’ as well. The management system will automate intakes that auto-validate, check-in and route submissions to specific reviewer destinations which in turn triggers certain workflows.