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A South Korea In-country Caretaker (ICC) is a local Korean entity that represents foreign pharmaceutical companies in Regulatory interactions with authorities to ensure compliance with Korean pharmaceutical regulations throughout the lifecycle of imported pharmaceutical products.

Foreign pharmaceutical manufacturers are required to appoint a locally established entity in South Korea to handle Regulatory responsibilities with Ministry of Food and Drug Safety (MFDS). The ICC serves as a critical bridge between Korean Regulatory authorities and foreign manufacturers, playing a central role in South Korea pharmaceutical market entry.

Main Responsibilities of a South Korea In-country Caretaker (ICC) 

The South Korea In-country Caretaker (ICC) performs several key Regulatory functions:

  • Regulatory Liaison: Serves as the official point of contact for the MFDS regarding all matters related to Regulatory submissions, product registration, importation, post-market safety monitoring, and compliance activities. These responsibilities align with strict MFDS ICC requirements governing foreign applicants.
  • Safety and Vigilance: Supports adverse event reporting, product recall or withdrawals coordination, and ongoing pharmacovigilance reporting or other safety monitoring obligations.
  • Recordkeeping: Maintains and preserves product-related documentation, including import records, quality documentation, and distribution tracking data, in accordance with MFDS recordkeeping requirements.
  • Document Handling: Receives Regulatory communications from MFDS, such as additional information, clarification, or Regulatory inspection notices, and ensures timely and proper responses.
  • Audit Facilitation: Coordinates with MFDS during Regulatory inspections, audits, or compliance reviews when required.
  • Change Notifications: Responsible for notifying MFDS of relevant Regulatory changes including updates to ICC information, Regulatory contact details, or product registration details when applicable.

Eligibility and Appointment Criteria 

To fulfill the responsibilities of an ICC, the appointed entity must:

  • Legal Presence: The ICC must be a legally established company or qualified individual located within South Korea, with full accountability under Korean law.
  • Professional Capacity: The organization should possess appropriate qualifications in pharmaceuticals, Regulatory affairs, or related fields and demonstrate the ability to actively fulfill safety and compliance obligations.
  • Designation Process: Appointment of the South Korea In-country Caretaker (ICC) is a mandatory part of the product registration application for all foreign manufacturers. Specific documentation—including proof of business registration and signed agreements—must be provided to MFDS.
  • Role in Dossiers: The ICC related information is included in the formal registration dossier, and any subsequent change mandates official notification to the authority depending on the Regulatory context.

Summary 

The South Korea In-country Caretaker (ICC) functions as the local Regulatory representative supporting foreign pharmaceutical companies operating in South Korea.

By ensuring compliance with MFDS ICC requirements, managing Regulatory communications, and maintaining post-market obligations, the ICC plays a critical role in enabling successful South Korea pharmaceutical market entry.

Conclusion 

Appointing a qualified South Korea In-country Caretaker (ICC), also known as a South Korea pharmaceutical local representative or MFDS Regulatory representative, is essential for meeting South Korea drug Regulatory requirements and ensuring uninterrupted pharmaceutical market entry.

Partnering with experienced providers like Freyr can help ensure seamless MFDS coordination, safety compliance, and ongoing Regulatory support.