[Anonymous]

Reply To: Regulatory release of IMP

I’ve worked with two models: In both models, QA is responsible for the GMP release and the shipment process / distribution system was used to control regulatory releases. Regulatory (whomever is submitting the filing IND / CTA, etc) or their delegate were able to mark the country as released in the system when they met the requirements of that country. The system checks site and country were approved before allowing a shipment request to be released for processing. The difference in the models is when the Reg team checks the released box per country in the system. 1 option was to tick the box when the submission was done knowing the importation of the drug product would not be able to be completed until the approval was received by the Health Authority. the other option was to wait until we received the regulatory approval and then update the system. The decision on which process to use was based on the level of risk tolerance in the organization and the confidence level in the importation process would catch if Reg approval hadn’t been received. The latter option is more widely used in my experience, although it can cause a bit of a rush right at the end of the process with urgently needed supplies, does ensure we aren’t initating shipments to countries that have not yet approved the study to run in the country.