The Korea Food and Drug Administration (KFDA) announced on the 12th that the Institute of Food and Drug Safety Evaluation will operate a new 'guidance' program starting this year to support the rapid commercialization of 20 innovative products, including new drugs, advanced bio-pharmaceuticals, and innovative medical devices.
The guidance program is a system that selects 20 innovative products and provides concentrated support for the approval process through focused consultation. Among the items that received prior consultations on pharmaceuticals and medical devices over the past three years, 58% have shown progress in the development stage. Therefore, the KFDA plans to provide concentrated support for 20 items with high commercialization potential and social urgency to increase the final approval success rate.
The 20 selected items will be assigned a product manager (PM) who will provide specialized consultation after prior consultation. Clinical reviews will support the review of clinical design appropriate for the development stage, non-clinical and clinical trial data, and the appropriateness of statistical methods. Additionally, it will facilitate the preparation of approval documents in conjunction with the fast-track review program and promote rapid commercialization by reviewing drafting standards in advance when necessary.
An integrated consultation gateway for innovative products will also be launched. The existing prior consultations, which were categorized into pharmaceuticals, medical devices, food, and other sectors, will be unified into an 'integrated consultation gateway for innovative products.' This streamlined process is expected to enable necessary regulatory support.
The KFDA will hold a meeting on the 13th to introduce the direction of the prior consultation system for the pharmaceutical industry titled '2025 Support Meeting for Global Pharmaceutical Development and Commercialization of New Technologies and Concepts.' The meeting will present the status and achievements of support for the commercialization of innovative products last year and the direction of the work of the commercialization strategy support group this year.
The KFDA stated, "We will continue to communicate with the industry to provide tailored regulatory support based on regulatory science," and noted, "We will support innovative new technologies and new concept products to enter the market quickly."