Announcement of 100 Major Tasks in Pharmaceutical and Medical Devices for 'Leap to a Global Bio Hub' (Comprehensive)

[Image source=Yonhap News]

[Asia Economy Reporter Kim Young-won] The Ministry of Food and Drug Safety (MFDS) is advancing innovation tasks by strengthening support for the food and pharmaceutical industries and easing certain regulations.

On the 11th, MFDS Commissioner Oh Yu-kyung 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. Commissioner Oh explained, "We aimed to accelerate new product development for the rapid global market entry of innovative products, strengthen the global competitiveness of the domestic pharmaceutical bio and food industries, and boldly improve unreasonable regulations that cause inconvenience or burden to the public while prioritizing public safety."

This initiative 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 through seven intensive internal discussions since June and sixteen meetings with industry and academic societies.

Commissioner Oh stated, "The three major regulatory innovation policies that MFDS intends to pursue have already been reported to the Prime Minister and received approval on the overall direction. We plan to plant 100 trees as an execution plan focusing on tailored regulations for the future, accelerating industrial development, and easing regulations that hinder businesses." She also expressed a commitment to continuous communication by planning outreach meetings and field visits to gather public opinions.

The 100 major tasks are divided into four areas: support for new industries (19 items), improvement of public inconvenience and burden (45 items), international harmonization (13 items), and resolution of procedural regulations (23 items), covering food and pharmaceutical regulations and support.

In the new industry support area, support for the development of COVID-19 vaccines and therapeutics amid the recent resurgence is 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, COVID-19 messenger RNA (mRNA) vaccine clinical trials require the use of 'manufacturing cell lines' established from research cell lines, which takes six months to establish. 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 phases 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 will be expanded. Previously, cannabis components were only permitted 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. MFDS plans to amend the Narcotics Control Act by December 2024 to allow domestic manufacturing and import of cannabis component pharmaceuticals.

[Image source=Yonhap News]

In the area of improving public burden, a plan to expand the eligibility for death compensation payments for adverse drug reaction relief from June 2024 is included. Currently, death compensation is paid only when there is a clear causal relationship between the cause of death and the adverse drug reaction. Going forward, compensation will be paid on a differentiated basis even when 'considerable causality' is recognized. Shin Kyung-seung, Director of the Pharmaceutical Safety Evaluation Division, explained, "Cases where it is clear that there are adverse reactions but other factors such as age or underlying diseases also contribute to death are considered to have considerable causality."

Compensation related to COVID-19 vaccines is handled by the Korea Disease Control and Prevention Agency and is separate from this announcement. Commissioner Oh said, "Issues related to COVID-19 vaccines and therapeutics are special cases, and I understand that the Disease Control Agency has established and is implementing separate relief procedures. Please understand that today's tasks apply to commonly prescribed pharmaceuticals used by the public."

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

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

The plan also includes easing procedural regulations related to the 'Food Consumption Expiration Date Labeling System,' which will start on January 1 next year. To ensure stable implementation and reduce the burden on companies, a one-year grace period will be provided from the enforcement date. This measure considers the difficulty of changing packaging for expiration date labeling by the enforcement date and the cost burden and resource waste from 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 pharmaceutical sectors are expected to become higher value-added and have greater market growth potential. We request the government to continuously pursue active regulatory easing to support companies' entry into new industries."

The Korea Consumer Organization Council agreed with abolishing or easing unnecessary or unreasonably restrictive regulations due to technological or environmental changes but emphasized, "Since food and pharmaceuticals are more closely related to public life than any other field, there is no room for compromise on safety. Therefore, while pursuing regulatory innovation, MFDS must faithfully uphold the primary value of consumer safety."

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