1. Reason for Amendment 

While the current system relaxes the certification requirements for innovative pharmaceutical companies if they have received approval for meeting the quality standards of the United States or the European Union, the lack of restrictions on when this approval was acquired means it may not adequately reflect a company's current manufacturing and quality management capabilities. Accordingly, this amendment aims to enhance the reliability and effectiveness of the innovative pharmaceutical company certification by requiring the submission of data regarding US or EU quality standards that was prepared within the last three years.

2. Main Contents 

A. Newly establishing a provision requiring companies to provide documentary evidence prepared within the last three years 

When a company that meets the quality standards of the US or the EU applies for an extension of its certification, a new provision mandates that it submit documentation prepared within the last three years in order to benefit from the relaxed research and development (R&D) expenditure criteria granted for meeting such international quality standards.