3002.51.00.00/CAR-T Cell Therapy for Leukemia/Japan

CAR-T Cell Therapy for Leukemia from Japan

Chimeric antigen receptor T-cell (CAR-T) therapy consists of patient-derived T-cells genetically modified to target CD19-positive cancer cells, used in treating relapsed B-cell acute lymphoblastic leukemia. Classified under HTS 3002.51.00.00 as cell therapy products, these are cell cultures modified via biotechnological processes for therapeutic use. They are administered intravenously after expansion and infusion preparation.

Duty Rate — Japan → United States

15%

Rate breakdown

9903.04.6215%Patented pharmaceutical articles that are the product of Japan, of a European Union member country, of South Korea, of Switzerland, or of Liechtenstein as provided for in subdivisions (c) and (f) of U.S. note 40 to this subchapter

9903.05.860%Articles provided for in subdivision (b) of U.S. note 52 to this subchapter

9903.05.900%Articles of aluminum, of steel or of copper or derivative aluminum or steel articles; passenger vehicles (sedans, sport utility vehicles, crossover utility vehicles, minivans and cargo vans) and light trucks; parts of passenger vehicles (sedans, sport utility vehicles, crossover utility vehicles, minivans and cargo vans) and light trucks; medium- and heavy-duty vehicles; parts of medium- and heavy-duty vehicles; wood products; patented pharmaceutical articles; and semiconductor articles, as provided in subdivision (f) of U.S. note 52 to this subchapter

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Import Tips

• Obtain FDA Biologics License Application (BLA) approval and IND documentation prior to import; cell therapies require pre-approval

• Maintain ultra-low temperature cold chain (-150°C or cryopreserved) with validated shipping containers to preserve cell viability

• Avoid misclassification as general immunological products; provide biotech modification certificates to confirm cell therapy status