(1) Reasons for Proposal

This Partial Amendment aims to improve and supplement the drug re-evaluation system by adding post-marketing database research as part of the special surveillance in post-marketing surveillance and deleting an item for the fixed number of cases in a post-marketing surveillance plan.

(2) Major Provisions

A. Diversify special surveillance methods in post-marketing surveillance (Article 2 paragraph 1)

B. Delete the item for the fixed number of cases in a post-marketing surveillance plan (Article 6 paragraph 4)