(1) Reasons for Proposal
Due to the enactment of the “Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis” so as to rapidly overcome a public health crisis (Act No. 17922, promulgated on March 9, 2021, enforced on March 9, 2021),the Act aims to set forth matters entrusted under the Act and other matters necessary for its implementation, such as the composition and operation of the safety management and supply committee for medical products in response to public health crises, and the designation of reserve medical products in response to crises.
(2) Major Provisions
A. Procedures and methods of measures for safe use, etc. (Article 15 Paragraphs 1-5)
B. Disposition of the revocation of permission for discontinued medical products (Article 16 Paragraph 4)
C. Establishment of administrative disposition standards (Article 21 and [attached Table 1])
D. Composition and operation of the committee, elimination, avoidance, and evasion of members (Articles 3 through 8)
E. Designation of reserve medical products in response to crises (Article 9)
F. Procedures and methods of expedited review (Article 10)
G. Procedures and methods of accompanied review on demand (Article 11)
H. Procedures and methods of applying for clinical trials, etc. (Article 12)
I. Application for conditional item permission, etc. (Article 13)
J. Procedures and methods of approval for emergency use (Article 14)
K. Establishment of follow-up survey plans (Article 17)
L. Announcement of value evaluation of medical products (Article 18)
M. Procedures and methods for the designation of medical products in response to crises (Article 19)
N. Scope, methods, and procedures of factual investigation (Article 20)
O. Procedures and methods of research and development support, etc. (Article 22)
P. Procedures and methods of free provision (Article 23)
Q. Procedures and methods of transfer and assignment (Article 24)
R. Fee (Article 25)
S. Request for extension of use-by dates of medical products in reserve in response to crises, etc. (Article 26)
