Support for Dementia Drug Development by MFDS through 'Regulatory Assistance'

The Ministry of Food and Drug Safety announced on the 7th that it will hold the ‘National R&D Commercialization Regulatory Support Meeting for Dementia Treatment Drugs’ in collaboration with the Dementia Overcoming Research and Development Project Group at the Seoul Square conference room in Jung-gu, Seoul, to ensure that government-supported dementia treatment drug research leads to product development.

[Image source=Yonhap News]

This meeting, involving dementia treatment drug researchers and related ministries such as the Ministry of Health and Welfare and the Ministry of Food and Drug Safety, will cover topics including ▲introduction of the consultation system to support product commercialization by the Ministry of Food and Drug Safety ▲guidance on pharmaceutical approval procedures ▲listening to difficulties and suggestions during dementia treatment drug research and development (R&D) ▲discussion of regulatory support measures by related ministries to support dementia treatment drug development ▲and provision of one-on-one customized consultations for each project.

The Ministry of Food and Drug Safety is promoting the 'BRIDGE Project,' which aims to standardize domestic regulations to global standards so that domestic new technologies can become innovative products leading the global market. The project provides R&D coordination, customized consultations (With-U), close consultations with regulatory experts, priority application of global standards, and expedited reviews. The Ministry plans to actively offer customized consultations by visiting the project group directly from the planning stage of dementia treatment drug development regarding product classification, development strategies, and clinical trial plan (IND) approvals.

An official from the Ministry of Food and Drug Safety stated, "We expect this meeting to help reduce trial and error during dementia treatment drug development and facilitate rapid product development," adding, "We will continue to do our best to support the swift commercialization of innovative new technology products based on regulatory science expertise."

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