(1) Reasons for Proposal
Since the Safety, Management, Etc. of Human Tissue Act has been amended including its main contents (Act No. 15898, promulgated on December 11, 2018) such as establishing a legal basis for the succession of tissue bank status, preparing the grounds for registration of the producer of the exporting country and for the import suspension measures to strengthen the safety management of importing human tissue, and making it possible to use nonconforming transplant tissue for study or quality control, the amendment aims to improve and complement a number of weaknesses that have emerged in the operation of the current system, such as establishing detailed procedures for the succession of tissue bank status, preparing details on the registration procedure and changes of the producer from the exporting country and on import suspension measures, and establishing reporting procedures following the use of the nonconforming transplant tissue for study.

(2) Major Provisions
A. Establish a reporting procedure for those cases where tissue that is unsuitable for distribution and transplant is used for study or quality control (Article 3 (8)).
B. Establish detailed procedures on the succession of tissue bank status and the effect of administrative sanctions (Article 7-2).
C. Establish standards and procedures for the renewal of permission of tissue banks (Article 8 (2))
D. Clarify the matters to be followed by the president of a tissue bank (Article 9, subparagraph 1)
E. Establish detailed procedures for import suspension measures against the producer from the exporting country (Article 17-3)
F. Establish a detailed procedure for registration and change registration of the producer from the exporting country according to the introduction of the registration system for the producer of human tissue exporting country (Article 17-5)
G. Speculate clearly the qualification and scope of the job of human tissue control officer (Article 22, Article 22-2, and Article 22-3).