Food and drug safety ministry speeds new drug approvals with revised guidelines

The food and drug safety ministry said July 31 it revised internal guidelines to accelerate new drug reviews, aiming to cut the total approval timeline to 240 days. The changes implement a broader innovation plan to shorten approval times for new drugs, biosimilars and advanced medical devices.

A key change shifts the first official request for additional data from the 87th day after application to as early as the 25th. Instead of waiting for a single consolidated notice, applicants will now receive ongoing review results by field, allowing them to address issues continuously.

The revisions also simplify the path for medicines initially approved as orphan drugs that later qualify as full new drugs. These products can now bypass redundant steps, including pre-application face-to-face meetings and kickoff conferences, when seeking status conversion.

To further support applicants, the ministry will hold at least two pre-application meetings before formal submission to help companies identify data gaps before the review period begins. The agency developed these measures after consulting with industry stakeholders through a public-private consultative body.

Supporting the faster timeline, the ministry recently hired 195 new staff members dedicated to licensing and examination duties. This influx enables a shift to a parallel review system where multiple aspects of an application are assessed simultaneously rather than sequentially.

Oh Yoo-kyung, head of the ministry, said the reforms would drive growth in the domestic bio-health sector and bring treatment opportunities to patients sooner while maintaining rigorous verification of safety and effectiveness.