(1) Reasons for Proposal

The purpose of this Amendment is to clarify matters delegated by the Act and Decree in accordance with the amended Rules on the Safety of Pharmaceuticals, Etc(Ordinance of the Prime Minister, No. 1429 amended on Dec. 13, 2017).

(2) Major Provisions

A. Clarify the subject of change in significant matters of the workroom for aseptic preparations, etc. (Article 2-2)

1) Conduct relevnace assessment where changes in the significant matters prescribed and announced by the Minister of Food and Drug Safety, such as replacing the air conditioning equipment in workroom for aseptic preparations, etc. under an Ordinance of the Prime Minister

2) Clarify that the new installation of the air conditioning equipment and the change in the size or position of the air inlet and outlet of the workroom (where sterilizing or filtering of bacteria, the previous workrooms are excluded) where the medicines are directly exposed during the aseptic process are the subjects of evaluation

3) Enhance the predictability of the work of pharmaceutical manufacturers, etc., and maintain appropriateness in relevance assessment work by clarifying the subject of pre-evaluation according to significant changes