[Alpha Biz= Kim Jisun] The U.S. Food and Drug Administration (FDA) is reportedly considering raising review fees for applications relying solely on foreign clinical data as part of efforts to strengthen domestic clinical trials, a move that could have significant implications for South Korea’s pharmaceutical and biotechnology industry.

According to industry sources on the 28th, the FDA recently discussed revising the Prescription Drug User Fee Act (PDUFA) during the Industrial Operations Advisory Committee meeting. The proposed revisions include fee reductions for companies conducting Phase 1 clinical trials within the U.S., while companies relying exclusively on overseas clinical data may face higher fees or be required to pay annual user fees. The current PDUFA legislation is set to expire in 2027, and detailed policy directions are expected to be clarified next year.

The changes are expected to create both opportunities and challenges for domestic companies. Contract development and manufacturing organizations (CDMOs) with U.S.-based production and development facilities could benefit from increased demand for outsourced development (CDO) services, such as clinical trial materials. Conversely, biotech firms that have been pursuing technology transfers based on Phase 1 data generated in South Korea may face higher costs as they would need to conduct early-stage trials in the U.S.

 

 

 

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