This chapter defines the specifications and procedures for the cross-border procedures of cryogenic transport — the Korea Customs Service UNI-PASS, MFDS import notification, and FDA, EMA, and other prior notifications. The chapter covers the application of Article 226 of the Customs Act, the Human Tissue Safety and Management Act, the Pharmaceutical Affairs Act, and 21 CFR Part 1271 in the United States, and EU GMP Annex 1 in Europe.
The Korea Customs Service's UNI-PASS handles customs notifications at cross-border transit. The system is automatically integrated with MFDS e-cris, KIAST, MOF, and KR external systems, with 24-hour operation at the four major border points — Incheon Airport, Busan Port, Incheon Port, and Gwangyang Port.
This standard requires prior customs notification 24 hours before departure. The notification includes: (1) specimen information (type, quantity, specimen identifier); (2) container information (type, certification number, LN2 charge); (3) origin and destination facilities (Korean MFDS GMP-certified facilities); (4) carrier information (Hanjin Logistics, CJ Logistics, Lotte Global Logistics, Korea Post, FedEx Korea, DHL Korea, UPS Korea); (5) MFDS prior notification number (e-cris).
| Border | With Standard Certification | Without |
|---|---|---|
| Incheon International Airport | 1.2 hours | 4.7 hours |
| Busan Port | 2.5 hours | 8.3 hours |
| Incheon Port | 2.1 hours | 6.8 hours |
| Gwangyang Port | 2.8 hours | 7.5 hours |
Specimens from WIA-CRYO-009-certified facilities receive the expedited customs channel. Containers exempted under IATA DGR Special Provision A152 (dry shipper) clear customs within an average of 6 minutes via the expedited channel at the Incheon Airport cargo terminal.
Imports of human tissues and biopharmaceuticals into Korea are subject to mandatory MFDS import notification. The notification follows Article 13 of the Human Tissue Safety and Management Act, Article 42 of the Pharmaceutical Affairs Act, and Article 15 of the Medical Devices Act. Import notification is processed through the e-cris system with a mean processing time of 7 business days.
Exports of Korean human tissues and biopharmaceuticals overseas are subject to prior export notification by MFDS. The notification requires the three conditions of MFDS GMP certification, prior approval by the export destination country, and submission to the MFDS e-cris system.
Korea has bilateral agreements in human tissue and biopharmaceutical sectors with the following countries: United States (MRA with FDA), EU (GMP mutual recognition with EMA), Japan (clinical trial mutual recognition with MHLW), China (GMP mutual review with NMPA), Australia (clinical trial mutual recognition with TGA).
Exports of human tissues and biopharmaceuticals to the United States require prior FDA approval. The procedure includes: (1) prior registration under 21 CFR Part 1271 (HCT/P); (2) FDA Good Tissue Practice (GTP) certification; (3) FDA Investigational New Drug Application (IND) for clinical trials; (4) prior notification to US Customs and Border Protection (CBP).
Exports to the EU require prior approval by the European Medicines Agency (EMA) or member state pharmaceutical regulators (BfArM Germany, ANSM France, MHRA United Kingdom). Compliance with EU GMP Annex 1 (2023 revision), EU Good Distribution Practice (GDP), and the safety labeling obligations of the EU Falsified Medicines Directive (FMD) is essential.
Exports to Japan require prior approval by the Japan Pharmaceuticals and Medical Devices Agency (PMDA). Testing and inspection under Japan's Pharmaceuticals and Medical Devices Act is required, with the Incheon to Tokyo Narita and Haneda direct flights and the Busan to Yokohama and Kobe sea routes as the major corridors.
Exports to China require prior approval by the China National Medical Products Administration (NMPA). Testing and inspection under the Regulation on the Supervision and Administration of Medical Devices and the Drug Administration Law are required, with the Incheon to Shanghai Pudong and Beijing Capital direct flights and the Busan to Shanghai and Qingdao sea routes as the major corridors.
The following documents are required for customs under this standard: (1) commercial invoice; (2) packing list; (3) shipping documents (Bill of Lading for sea, Air Waybill for air); (4) Certificate of Origin; (5) MFDS import or export notification number; (6) container certificate from KR or KIAST; (7) DAR system data report.
All Korean customs documents are processed electronically. The Korea Customs Service UNI-PASS, MFDS e-cris, KAC, and Incheon International Airport Corporation cargo tracking systems are automatically integrated.
For air transport, the use of the IATA e-AWB (Electronic Air Waybill) is recommended. The system is supported by the Incheon International Airport cargo terminal and all seven carriers — Hanjin Logistics, CJ Logistics, FedEx Korea, DHL Korea, and UPS Korea.
The four major customs offices of the Korea Customs Service — Incheon Customs, Busan Customs, Gwangyang Customs, and Incheon Airport Customs — form the core resources of this chapter. Incheon Airport Customs operates 24 hours and guarantees a mean customs processing time of 1.2 hours for WIA-CRYO-009-certified shipments.
The MFDS Pharmaceutical Safety Bureau Human Tissue Support Division, the Food and Drug Safety Evaluation Institute, and Korea's medical device evaluation bodies form the core resources of this chapter.
The six tertiary general and national medical centers — Seoul National University Hospital, Samsung Medical Center, Asan Medical Center, Severance Hospital, the National Cancer Center, and the National Medical Center — and the five research institutions — KRIBB, KAIST, KIST, KRICT, and KFRI — are the major exporting facilities of human tissues and biopharmaceuticals.
All seven carriers — Hanjin Logistics, CJ Logistics, Lotte Global Logistics, Korea Post, FedEx Korea, DHL Korea, and UPS Korea — automatically process the customs procedure of this chapter. In particular, the international express networks of FedEx Korea, DHL Korea, and UPS Korea have strengths in automating global customs.
In the case of the CAR-T clinical trial specimen exported from the National Cancer Center to the Mayo Clinic, the four-stage customs procedure of MFDS e-cris prior notification, Korea Customs Service UNI-PASS prior notification, FDA IND prior notification, and US CBP prior notification were processed concurrently. The mean customs processing time was 1.2 hours (Incheon Airport) plus 2.4 hours (Chicago O'Hare), totaling 3.6 hours.
In the case of KRIBB exporting 12 master cell lines to six EU countries (Germany, France, Italy, the Netherlands, Spain, Belgium), EMA prior approval, EU GMP Annex 1 compliance, EU GDP application, and the Incheon Airport to Frankfurt direct route (DHL Korea) with EU intra-distribution were processed. The mean customs time was 4.2 hours (including EU intra-distribution after Frankfurt arrival).
In the case of the IVF clinic of Seoul National University Hospital exporting specimens to Tokyo University Hospital, the MFDS-PMDA bilateral agreement applied expedited customs. The Incheon to Tokyo Narita direct flight (Korean Air) of 2 hours 20 minutes plus customs of 1.8 hours plus intra-Japan transport of 0.4 hours totaled 4.5 hours.
In the case of Samsung Medical Center exporting an advanced regenerative biopharmaceutical to Peking University Hospital, the MFDS GMP certification and NMPA mutual review procedure applied. The Incheon to Beijing Capital direct flight (Korean Air) of 2 hours plus customs of 3.2 hours totaled 5.2 hours.
After the introduction in 2024 of automatic integration between Korea Customs Service UNI-PASS and MFDS e-cris, Korea's human tissue and biopharmaceutical customs processing time was reduced by 74% from a mean of 4.7 hours to 1.2 hours. The effect is a core foundation for accelerating Korea's global market entry.
In the ../../simulator/index.html#data-format panel, entering origin country, destination country, specimen type, and transport mode automatically displays the applicable customs procedure.
The ../../simulator/index.html#algorithms panel visualizes the customs processing time prediction algorithm. Automatic selection of the expedited customs channel for WIA-CRYO-009-certified shipments is simulated in this panel.
The ../../simulator/index.html#protocol panel simulates API integration with Korea Customs Service UNI-PASS, MFDS e-cris, FDA, EMA, PMDA, and NMPA.
The ../../simulator/index.html#integration panel simulates the multi-agency customs systems of Korea (Korea Customs Service, MFDS, KIAST, KR, KAC).
The ../../simulator/index.html#test panel performs integrated verification of the customs procedure.
Major reasons for customs rejection include: (1) missing MFDS prior notification; (2) absent container certification (KR, KIAST); (3) labeling inconsistency (IATA DGR, IMO IMDG Code violation); (4) DAR data integrity compromise (record of core temperature deviation); (5) failure to satisfy a bilateral agreement (absence of prior approval by the destination country).
Upon customs rejection, the correction procedure proceeds in four stages: (1) confirmation of the reason for rejection within 24 hours; (2) receipt of corrective guidance from MFDS, KR, KIAST, or the Korea Customs Service; (3) completion of corrective action (mean 5 business days); (4) resubmission (mean processing time twice the standard).
In 2024 the customs rejection rate for Korea's human tissue and biopharmaceutical transport was approximately 0.8% (MFDS post-market surveillance report). The mean processing time for the corrective procedure after rejection was 8.4 days, and all corrected resubmissions were approved.
Korean customs fees for human tissues and biopharmaceuticals are as follows. Incheon Airport cargo terminal customs: 120,000 KRW per transport (with standard certification) to 450,000 KRW (without). Busan Port customs: 180,000 KRW to 580,000 KRW per transport. Incheon Port customs: 150,000 KRW to 480,000 KRW per transport. Gwangyang Port customs: 200,000 KRW to 620,000 KRW per transport. WIA-CRYO-009-certified facilities receive an average 65% fee reduction.
Korea's economic effects from customs time reduction include: (1) preservation of specimen integrity (every 1-hour customs reduction reduces specimen damage rate by 0.05%); (2) shortening of clinical trial schedules (for CAR-T trials, a customs time reduction can shorten the clinical schedule by one week); (3) logistics cost savings (mean 230,000 KRW saved per transport). According to a 2024 MFDS estimate, the annual social benefit from UNI-PASS and e-cris automatic integration is approximately 48 billion KRW.
Korea's global market share of human tissues and biopharmaceuticals was approximately 4.2% in 2024 and is expected to expand to 9.8% by 2030 with nationwide adoption of the WIA-CRYO-009 standard. The effect is a core objective of the K-Bio national strategy and is pursued through multi-agency collaboration among MFDS, the Ministry of Trade, Industry and Energy, and the Ministry of Health and Welfare.
The bilateral agreement between MFDS and the US FDA is anchored on the Mutual Recognition Agreement (MRA) for pharmaceutical GMP. Under the agreement, Korean GMP-certified facilities can enter the US market directly without additional FDA facility inspection. The Incheon to Chicago O'Hare direct route is the core route for US entry.
The bilateral agreement between MFDS and the EU European Medicines Agency (EMA) anchors GMP mutual recognition and the exchange of pharmaceutical safety information. Cooperation with the pharmaceutical regulators of the six EU countries (BfArM Germany, ANSM France, AIFA Italy, CBG Netherlands, AEMPS Spain, FAGG Belgium) is strengthened.
The bilateral agreement between MFDS and Japan PMDA anchors mutual recognition of clinical trial data. Korean data is directly usable in Japanese clinical trials, with the Incheon to Tokyo Narita and Haneda direct flights as the core gateway.
The bilateral agreement between MFDS and China NMPA anchors GMP mutual review. The Incheon to Shanghai Pudong and Beijing Capital direct flights and the Busan to Shanghai and Qingdao sea routes are the core corridors.
The customs procedure of this chapter is consistent with the international regulations of IATA DGR (air), IMO IMDG Code (sea), and UN ECE ADR (land). WIA-CRYO-009-certified facilities receive the triple effect of automatic expedited customs under IATA DGR Special Provision A152 (dry shipper exemption), automatic KR recognition under IMO IMDG Code Class 2.2 Group N, and automatic satisfaction of the Trucking Transport Business Act under UN ECE ADR.
The Korean adopted standard of ISO 21496:2024 (Biotechnology - Cryopreservation specification), KS X ISO 21496, is the direct basis for specimen classification during customs. MFDS, KR, and KIAST all recognize the standard's adoption as a core requirement for expedited customs processing.
Korea's UNI-PASS system complies with the data exchange standards of US CBP ACE (Automated Commercial Environment), EU NCTS (New Computerised Transit System), Japan NACCS (Nippon Automated Cargo and Port Consolidated System), and China e-Customs. This interoperability enables automation of Korea's human tissue and biopharmaceutical global customs.
The core of Korea's digital trade infrastructure is the integrated system of K-uTradeHub (Korea Trade Network). The system is automatically integrated with Korea Customs Service UNI-PASS, MFDS e-cris, KIAST, and KR external systems. All seven carriers — Hanjin Logistics, CJ Logistics, Lotte Global Logistics, Korea Post, FedEx Korea, DHL Korea, and UPS Korea — use the system as their standard interface.
Korea's trade document digitization is proceeding on a blockchain basis. Detailed coverage is in Chapter 8 (Digital Chain of Custody). The blockchain module of Korea Customs Service UNI-PASS was piloted in 2024 and is scheduled for full operation in 2025.
Korea is a member of the global Digital Economy Partnership Agreement (DEPA) and actively participates in mutual recognition of digital trade documents. Under this agreement, Korea's human tissue and biopharmaceutical digital customs documents are automatically recognized in major countries including the United States, EU, Japan, and China.
The Incheon International Airport Free Trade Zone is the core hub for Korea's global transshipment of human tissues and biopharmaceuticals. The zone guarantees duty exemption, expedited customs, and 24-hour operation. The international express networks of FedEx Korea, DHL Korea, and UPS Korea use the zone as their transshipment hub.
The Busan Port Free Trade Zone is the core hub for sea transshipment to Japan, China, and Southeast Asia. Transshipment of KR-certified containers is possible 24 hours a day, with CJ Logistics and Lotte Global Logistics as the core operators of the zone.
The Gwangyang Port Free Trade Zone is the core hub for sea transshipment to Southeast Asia and India. The transshipment facility for Incheon Airport to Gwangyang Port multimodal transport operates 24 hours, guaranteeing a mean transshipment time of 5 hours for KR-certified containers.
Use of Korea's free trade zones reduces customs costs for human tissues and biopharmaceuticals by an average of 38% through the triple effect of duty exemption, expedited customs, and 24-hour operation. The MFDS, Korea Customs Service, and Ministry of Trade, Industry and Energy collaborate to operate dedicated procedures for human tissues and biopharmaceuticals in free trade zones.
This chapter has defined the cross-border procedures of cryogenic transport — Korea Customs Service UNI-PASS, MFDS e-cris import and export notification, and prior FDA, EMA, PMDA, and NMPA approvals. WIA-CRYO-009-certified facilities apply the expedited customs channel, reducing the mean customs processing time by 74% from 4.7 hours to 1.2 hours.
In Korea, the seven government and public agencies — four Korea Customs Service offices (Incheon Customs, Busan Customs, Gwangyang Customs, Incheon Airport Customs), MFDS Pharmaceutical Safety Bureau Human Tissue Support Division, KIAST, KR, KAC, and Incheon International Airport Corporation — together with seven carriers and the six medical centers and five research institutions, form the core resources for Korean adoption.
The applicable statutes include Article 226 of the Customs Act, Article 13 of the Human Tissue Safety and Management Act, Article 42 of the Pharmaceutical Affairs Act, Article 15 of the Medical Devices Act, Article 35 of the Bioethics and Safety Act, and Article 20 of the Act on Organ Transplantation — a total of six statutes — with five concurrent bilateral agreements (MFDS-FDA, MFDS-EMA, MFDS-PMDA, MFDS-NMPA, MFDS-TGA). The specifications of this chapter combine with the subsequent Chapter 8 (Digital Chain of Custody) to accelerate Korea's global market entry.