MFDS Launches 'Product Commercialization Strategy Support Group' in Biohealth Sector

Priority Support for Products with High Public and Industrial Value
Product Commercialization Support Team, Innovative Product Review Team, Clinical Review Team
Support for Non-clinical and Clinical Design and Consultation... Accelerated Review Process

[Asia Economy Reporter Kim Young-won] The Ministry of Food and Drug Safety (MFDS) will establish a dedicated support team responsible for overseeing the development of biohealth products from start to finish.

On the 25th, the MFDS announced the launch of the "Product Commercialization Strategy Support Team" to support the rapid market entry of public health crisis response drugs, new concept and new technology drugs, and to foster the biohealth industry.

Until now, the MFDS has operated product commercialization support projects by product category, such as pharmaceuticals (PharmNavi), biopharmaceuticals (Majungmul), and medical devices (Approval Helper). Regulatory consultations have been handled by the "Pre-consultation Division," a dedicated consultation department established in August 2020.

The support team will provide services such as linking "development - non-clinical" and "clinical - approval review" stages and specialized services for clinical trial design. Support functions have been strengthened to accelerate entry speed at each development stage.

Products judged to have high public interest or industrial value will be prioritized for support. These include public health crisis response drugs, rare medicines, domestically developed new drugs, innovative medical devices, and new functional food ingredients. The support team will prioritize these and plans to gradually expand the scope of support in the future.

The head of the support team will be the Director of the National Institute of Food and Drug Safety Evaluation. The team is composed of three units: the Product Commercialization Support Team, the Innovative Product Review Team, and the Clinical Review Team, with a total of 90 members.

The Product Commercialization Support Team is responsible for in-depth consultations on quality, non-clinical, and clinical aspects. For new technology products that have difficulty preparing approval review materials, they also provide regulatory services through discussions with each review department.

The Innovative Product Review Team selects "priority review" products from the development stage and operates the "Continuous Concurrent Review" program to shorten the approval period for completed products. Continuous Concurrent Review means receiving and reviewing data at each stage such as clinical trials, rather than only reviewing promising therapeutics at the final approval stage.

The Clinical Review Team reviews (non-)clinical data and clinical trial plans, and assists with detailed clinical design in coordination with consultations from the Product Commercialization Support Team.

Kim Kang-lip, Commissioner of the MFDS, said, "We will strive to harmonize regulations at the market entry stage with international standards and reduce uncertainties to create an environment where our companies can go beyond international regulatory levels and advance into the global market."

This content was produced with the assistance of AI translation services.