1. Reasons for Enactment

The Amendment provides detailed standards for the designation of specialized rare disease institutes, prescribes matters necessary for the designation and revocation according to the standards, and thereby ensures the purpose and efficiency of system operation.

2. Major Provisions

A. Provides detailed standards for the designation of specialized rare disease institutes (Article 2 and attached table).

B. Provides matters necessary for the designation and revocation of specialized rare disease institutes (Article 3).