1. Reason for Amendment 

This amendment aims to promote the continuous expansion of research and development (R&D) investment and the generation of innovative outcomes by upwardly adjusting the required ratio of pharmaceutical R&D expenses to pharmaceutical sales among the certification criteria for innovative pharmaceutical companies. Furthermore, while Article 12 of the "Special Act on the Promotion and Support of the Pharmaceutical Industry" stipulates that the categorization of innovative pharmaceutical companies by type shall be prescribed by Presidential Decree, such regulations are currently insufficient. Accordingly, this amendment seeks to ensure rationality and equity in the operation of the certification system by classifying innovative pharmaceutical companies into general pharmaceutical companies and foreign pharmaceutical companies.

2. Main Contents 

A. Upwardly adjusting the required ratio of pharmaceutical R&D expenses to pharmaceutical sales within the certification criteria by 2 percentage points (2/100)

B. Newly establishing a provision that classifies innovative pharmaceutical companies into general pharmaceutical companies and foreign pharmaceutical companies