"The Ministry of Food and Drug Safety (MFDS) in South Korea has issued a user guidance document explaining the procedure for submitting and managing applications for changes to approved clinical trial plans through the Drug Safety Korea electronic portal system. The guidance supports companies handling a Clinical Trial Amendment through the official Drug Safety Korea System.
The guidance outlines the purpose and scope of Clinical Trial Application amendment approvals and provides step-by-step instructions for navigating the electronic application system, including user registration, login procedures, and menu access for clinical trial plan modifications. The document further explains how applicants can search and select approved clinical trial numbers, update sponsor and product information, modify manufacturing site details, dosage forms, composition, storage conditions, and manufacturing methods.
It also provides instructions for uploading revised supporting documents such as clinical trial protocols, test methods, and comparison tables for proposed changes as part of the Electronic Regulatory Submission process. Additionally, the guidance covers procedures for submitting civil applications related to clinical trial plan changes, including amendments submitted during ongoing initial approval reviews. Support information and system inquiry contacts are also included to assist applicants using the online platform.
The guidance aims to improve the efficiency, consistency, and transparency of Electronic Regulatory Submission activities related to clinical trial amendments in South Korea."
Select Mandate HA
Select Mandate Function