MFDS Announces 100 Major Tasks for Food and Drug Regulatory Innovation as Part of Yoon Administration's National Agenda

Support for COVID-19 Vaccine and Treatment Development
Expansion of Relief for Adverse Drug Reactions
Domestic Manufacture and Import of Cannabis Medicines Allowed, etc.

[Asia Economy Reporter Kim Young-won] The government has begun full-scale implementation of national tasks aimed at advancing into a bio and digital health-centered nation.

On the 11th, Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety (MFDS), announced the '100 Major Tasks for Food and Drug Regulatory Innovation' together with the Korea Chamber of Commerce and Industry and the Korea Consumer Organization Council. This initiative was prepared to strengthen the global competitiveness of the domestic food and drug industry while abolishing or easing unreasonable regulations that are not directly related to safety and do not fit the current era and environment.

This task list is part of the Yoon Suk-yeol administration's national agenda strategy to become a 'Global Hub for Bio and Digital Health.' It reflects opinions gathered from seven intensive internal discussions held by the MFDS since June, as well as 16 meetings with industry and academic circles.

The 100 tasks are divided into four areas: support for new industries (19 items), improvement of public inconvenience and burdens (45 items), international harmonization (13 items), and resolution of procedural regulations (23 items). They cover regulations and support related to food and drugs.

In the new industry support sector, support for the development of COVID-19 vaccines and therapeutics amid the recent resurgence has been included. A 'Rapid Clinical Support Platform' will be established next month to shorten the development period of vaccines and therapeutics by more than six months.

Currently, clinical trials for COVID-19 messenger RNA (mRNA) vaccines require the use of 'manufacturing cell lines' established from research cell lines, which takes six months just to establish the cell lines. The task allows the use of research cell lines for vaccine production. For therapeutics, considering the characteristics of COVID-19 variants, flexible designs such as integrating Phase 2 and 3 clinical trials are recognized to simplify the review and approval process of clinical trial plans.

Additionally, the scope of medical use of cannabis in Korea is expected to expand. Previously, cannabis components were only allowed for academic research and limited medical purposes, but the scope will be broadened considering the international trend of using cannabis for medical purposes and the treatment rights of patients with rare and intractable diseases. The MFDS plans to revise the Narcotics Control Act by December 2024 to permit domestic manufacturing and import of cannabis component pharmaceuticals.

In the area of reducing public burdens, from June 2024, the scope of recipients for death compensation related to adverse drug reactions will be expanded. Currently, death compensation is paid only when there is a clear causal relationship between the cause of death and adverse drug reactions. Going forward, compensation will be paid on a differentiated basis even when 'considerable causality' is recognized. Shin Kyung-seung, Director of the Drug Safety Evaluation Division, explained, "If it is clear that adverse reactions exist but other factors such as age or underlying diseases also contributed to death, this is considered considerable causality."

Furthermore, the options for clinical trial drugs available for treatment of severely ill patients without alternative therapies are expected to increase. Currently, approval for treatment use can only be applied for clinical trial drugs approved domestically, but the Pharmaceutical Affairs Act will be amended by December 2023 to allow applications for drugs approved overseas as well.

In the international harmonization sector, the MFDS will establish a 'Global Food and Drug Policy Strategy Task Force' to strengthen international competitiveness in the food and drug sector. The task force will handle international regulatory harmonization and proactive export support to assist domestic companies in exporting. Lee Ho-dong, Director of Innovation Administration at the MFDS, said, "The task force will start as an internal MFDS organization with a staff of seven. Additionally, two trade experts from the private sector will be added."

The plan also includes resolving procedural regulations related to the 'Food Expiration Date Labeling System,' which will begin on January 1 next year. To ensure stable establishment of the system and reduce the burden on companies, a one-year grace period will be provided from the implementation date. This measure considers the difficulty of changing packaging for expiration date labeling by the implementation date and the cost burden and resource waste caused by discarding existing packaging.

The Korea Chamber of Commerce and Industry, which jointly announced the tasks, stated, "With recent advances in cutting-edge technology, the food and drug sector is expected to become more high value-added and the market growth potential is expected to increase," and requested, "The government should continue to actively promote regulatory easing to support companies' entry into new industries."

The Korea Consumer Organization Council agreed with "abolishing or easing regulations that have become unnecessary due to technological or environmental changes or that act unreasonably on corporate activities," but urged, "When promoting regulatory innovation, please prioritize the value of consumer safety."

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