(1) Reasons for Proposal
This amendment aims to promote rational operation of the Drug Master File system so that the pharmaceuticals that need to secure the permitted pharmaceutical equivalence shall be subject to the Drug Master File and that shortage prevention pharmaceuticals shall be temporarily excluded from the Drug Master File until the Drug Master File for the pharmaceuticals that need to secure the permitted pharmaceutical equivalence is stabilized.

(2) Major Provisions
A. The pharmaceuticals that need to secure the permitted pharmaceutical equivalence among shortage prevention pharmaceuticals shall be excluded from the Drug Master File.
B. The drug substances used to manufacture the pharmaceuticals that need to secure the permitted pharmaceutical equivalence shall be designated as pharmaceuticals for the Drug Master File (Addendum Article 5 of the Notice of Ministry of Food and Drug Safety No. 2016-59).