MFDS Declares 'Customized and On-site Regulatory Innovation' ... "Leap to a Global Hub Nation"

Announcement of 'Food and Drug Administration Innovation Plan' Leading International Standards
Customized Innovation for Promising New Technology Fields... Expansion of Medifood Types
Private Sector Responsibility and Autonomy Strengthened... Transition to a Speedy Regulatory Support System

[Asia Economy Reporter Jo In-kyung] The Ministry of Food and Drug Safety (MFDS) is launching regulatory innovation focused on 'customized and field-experienced' approaches in the bio and digital health sectors. The plan aims to support the global market entry of domestic industries and create an environment where the public can quickly benefit from new technologies guaranteed to be safe.

On the 28th, at the 4th Government Policy Coordination Meeting chaired by Prime Minister Han Duck-soo, the MFDS reported the 'Food and Drug Administration Innovation Plan Leading International Standards,' which includes ▲establishing a customized regulatory system specialized for new technologies ▲transitioning to a fast-paced full-cycle regulatory support system ▲operating a field-experienced regulatory innovation inspection system.

First, acknowledging concerns that existing regulations delay market entry for advanced biopharmaceuticals and innovative medical devices applying new technologies, the MFDS will proactively establish customized regulations. Before approving new drugs such as messenger RNA (mRNA) and microbiome-based medicines, safety evaluation standards and regulations tailored to the characteristics of new technologies will be prepared in advance, and technical support will be strengthened.

For digital health devices applying artificial intelligence (AI) and other technologies, the regulatory framework for clinical trials and approvals will be completely redesigned, and the scope of the negative regulation system?where all actions not prohibited are allowed?will be expanded.

Development guidelines will also be introduced to support the food tech industry, including foods applying advanced biotechnology such as cell culture. Safety evaluation standards for cell-cultured foods, such as cultured meat produced by harvesting animal cells and cultivating them using biotechnology, will be established to support product launches.

The category of patient foods called 'Medifood' will be expanded from 13 types, including intestinal diseases, kidney diseases, and diabetes, to a total of 18 types by adding hypertension and liver diseases. A customized health functional food system that can meet individual demands will also be introduced.

Alongside this, the MFDS will transition to a fast-paced regulatory support system providing a 'fast track' throughout the entire process from research and development to approval review and global market entry. By strengthening the linkage between research and development and domestic and international approvals, it will minimize trial and error in product commercialization and provide one-on-one close support through the Product Commercialization Strategy Support Group.

Additionally, to secure regulatory response capabilities across the industry, the MFDS plans to nurture talent by producing 600 master's and doctoral graduates in regulatory science and expand expert reviewers.

The MFDS will also strengthen its status as an advanced regulatory country. By registering as a World Health Organization (WHO) Listed Authority (WLA), it plans to lead international standards in fields such as digital health and expand mutual review and approval exemption bases. The WLA is a system introduced this year by WHO to evaluate and certify the regulatory capacity and performance of pharmaceutical regulatory agencies. South Korea is the first country in the world to pursue registration this December.

Simple procedural regulations that do not directly relate to safety or health will be reconsidered from the ground up, and new biohealth industries will strengthen private sector autonomy based on the principle of 'prior approval, post-regulation.' To this end, the MFDS will gather opinions from field experts and industry responses to establish a '100 Major Regulatory Innovation Tasks Roadmap,' which will be announced and implemented next month.

To promptly resolve field difficulties and related regulations, a 'Three-Tier Regulatory Resolution System' including external experts will be introduced and operated. When companies propose regulatory resolutions, the process will proceed through the business department, the Regulatory Verification Committee, and the Regulatory Innovation Inspection Meeting to thoroughly verify from the field's perspective and increase acceptance.

MFDS Commissioner Oh Yu-kyung said, "The food and drug industry, including bio and digital health, is expected to continue to be driven by innovative new technology products." She added, "We will boldly innovate outdated regulations that cannot accommodate new concept products to international standards and actively support the industry's challenges and innovations by providing fast-paced support."

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