Fee-Charging Standards for Lot Release, Reference Materials, and Testing of Foods, Drugs and Cosmetics

These standards are established pursuant to Article 58 of the Act Governing Food Safety and Sanitation, Paragraph 2 of Article 104-2 of the Pharmaceutical Affairs Act, Paragraph 2 of Article 76 of the Medical Devices Act, Article 30 of the Cosmetic Hygiene and Safety Act, and Article 10 of the Charges and Fees Act.

Contents of the standards are laid down in the Appendix.Appendix.PDF

On grounds for humane or relief purposes, biological preparations in the D numbering section of the Appendix that donated by international organizations, countries or pharmaceutical corporations can be exempted from all fees upon approval by the central competent authorities.

These standards shall be implemented as of its being promulgated.