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Korea to ease 15 regulations on biopharmaceuticals
  • By Kwak Sung-sun
  • Published 2020.01.15 16:36
  • Updated 2020.01.15 16:36
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The government said it would provide mileage points to people who improve their lifestyles for better health so that people can use them for the payment of medical bills or health examinations.

The government said related ministries established measures to improve key regulations in the biohealth sector at a ministerial meeting for innovation and growth strategies on Wednesday.

In response to the industries’ demand for the use of medical data and more biological research, the government formed a committee to push for innovative strategies for the biohealth industry and started to identify and improve regulations from September last year.

Under the deregulation plan, the government decided to ease 15 biohealth-related regulations in four areas, as requested by the R&D and business sector.

Korea to promote disease prevention, health management services

To enhance the public health, the government will adopt a health management service certification system so that consumers can choose to take the health management service and launch a pilot program to offer incentives for those who manage their health better in the second half.

Under the pilot program, the government will provide mileage points based on the results of the practice of healthy life so that consumers can use the points when paying for health checkups and medical costs.

The government will also expand items for direct-to-consumer genetic testing services from 12 to 56 in the disease prevention and health management sector. Within this month, the government will implement the second pilot program and add over 20 items to the service area.

The government also seeks to unify the certification system for genetic testing, while many institutions are providing their certification systems. The government plans to allow mutual recognition of the common evaluation items and the integration of application forms for genetic testing.

Korea to allow recycling of body fat

To set up a research environment for new growth engines, the government will expand the use of medical data, enable the recycling of discarded fat, and draw up guidelines for derivative research resources.

Although hospitals own a vast amount of healthcare data, they find it almost impossible to use them to develop rare disease treatments or innovative medical devices because the law strictly prohibits the use of medical data for the protection of personal information. Medical data can be used only for public research.

However, the National Assembly passed a revision bill of the Personal Information Protection Act last week to allow the use of medical data by a third-party under a pseudonym. Following the passage of the bill, the government plans to widen the use of healthcare data for scientific purposes, such as the development of drugs and medical devices.

Human fat, categorized as medical waste, is prohibited from recycling. However, the government will revise the Wastes Control Act so that discarded fat can be reused for stem cell research-related drug development.

As the demand for research on new types of human-derived resources such as microbiomes and organoids increased, the government will prepare the institutional ethics board (IRB) deliberation guidelines to utilize biological resources better.

Besides, the government will set up a new category for “masters” in the bio-health sector where high expertise such as biopharmaceutical production process management is required so that the industry can accumulate skills, technologies, and nurture professionals in the sector.

Establishing new VR/AR-based medical device section

To support the growth of innovative medical devices, the government will set up a new section for virtual reality and augmented reality-based medical devices and improve the new medical technology evaluation system.

Accordingly, there will be new licensed items for convergence medical devices such as VR- and AR-based software for cognitive behavioral therapy, which is currently not categorized for separate approval.

The government will set up a sub-law so that medical devices that adopted new technologies such as AI-based medical diagnostic imaging can win a fast-track review by the Ministry of Food and Drug Safety, as the new law in April designated them as innovative medical devices.

For extensive use of in-vitro diagnostic tests, which account for 50 percent of all new medical technology evaluations, the government will expand the “market entry-first and post-evaluation system” to all in-vitro diagnostic tests. The government has been applying the system to detect infectious diseases in a pilot program since April last year.

Lastly, the government said it would scrap double regulations.

The government will ease the restriction on the size of the manufacturing site in a high-tech healthcare complex from 3,000 square meters to 5,000, exempt Grade 1 and 2 medical devices from electrical appliance safety certification, adopt a preliminary review system for private advertisements of medical devices, improve reporting system for medical device supply records, and set a time limit for the payment of medical device supply to improve market orders.


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