(1) Reasons for Proposal

This Partial Amendment aims to require the submission of analysis and evaluation of information collected during the effective period and subsequent safety management measures in submitted data for a Drug Renewal System application; accept the effective period of a domestic drug, which is converted into an export drug and then converted back into a domestic drug, as the remaining period from the original effective period, which is given before the drug is converted into an export drug, minus the export period, and otherwise reasonably improve shortcomings arising from the operation of the current system 

(2) Major Provisions

A. Add a requirement for the submission of data for safety management in filing a Drug Renewal System application (Article 5 (1) and (2))

Require additional submission of data about safety management measures as well as the results of analysis and evaluation by the drug safety officer on the data collected in addition to the expedited and regular report data collected during effective period. 

B. Apply the effective period when the export drug is converted back into a domestic drug (Article 11 (2))

Accept the effective period of the domestic drug, which is converted into an export drug and then converted back into a domestic drug, as the remaining period from the original effective period, which is given before the drug is converted into an export drug, minus the export period.