(1) Reasons for Proposal

The Amendment aims to strengthen the safety management for drug quality by requiring, for improvement, the submission of materials conecerning the establishment and management of quality control standards for genotoxic/carcinogenic related substances, which are used for drug approval/evaluation information; and differentiates the materials submitted for the approval/evaluation of over-the-counter drugs from those of new drugs, thereby addressing weaknesses arising from the current system.

(2) Major Provisions

A. Require submitting the evidential information of safety for genotoxic or carcinogenic and metallic impurities of drugs (Article 7)

B. Improve the system to streamline the submission of analytical control system information for confirming the reliability of the clinical trial of drugs (Article 7)

C. Provide grounds for withdrawing the marketing approval in a voluntary manner to enhance the clarity and predictability of the administrative activities (Article 55-3)

D. Newly insert the "scope of submitting information for approval/evaluation for over-the-counter drugs," which reflects the nature of over-the-counter drugs different from prescription drugs; and exempt the information which is meaningless when developing over-the-counter drugs (attached Table 1)

E. Clarify how to describe in detail and prepare considerations when preparing risk/benefit evaluation items (attached Table 3)