Dear Colleagues,
My Team and I are supporting a CT application in South Korea. The investigational product as well as the placebo to be used in the clinical trial are registered marketed products in the US and elsewhere in a different therapeutic indication. These products are not registered in South Korea.
My question relates to the requirements for data on manufacturing and quality (Q-IMPD) to be submitted as part of the CTA.
For example, as per the EU guideline (EMA/CHMP/BWP/534898/2008) 'if the active substance used is already authorized in a finished product within the EU/EEA or in one of the ICH regions, reference can be made to the valid marketing authorization.' In this specific situation, not all the data and documentation is required to be submitted in the IMPD but a simplified IMPD will suffice, or even just the reference to the valid marketing authorization.
Does anyone know if this regulatory strategy and approach would be acceptable in South Korea as well, provided the IMP is not registered there but in other ICH countries?
Thank you in advance for your insights. Happy Thanksgiving.
Sincerely, Olga
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Olga Neumueller
Associate Director Global Regulatory Affairs
Bradley IL
United States
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