The government will shift the biohealth review process, which used to proceed step by step and take a long time, to simultaneous and parallel reviews. The aim is to shorten the time required for new drug reviews and expand patients' access to treatment.
Siting regulations will also be improved to expand agrivoltaics. The government will lift the restriction under the current Farmland Act that limits the installation of solar power facilities in agricultural promotion zones, and extend the farmland use period for solar power projects by 15 years, from the current 8 years to 23 years.
The government said it made this decision at the "strategy meeting on rationalizing key regulations," presided over by President Lee Jae-myung, at the presidential office in Yongsan, Seoul, on the 16th. The meeting discussed regulatory improvement plans for new industries, including bio, renewable energy and the circular economy, and K-culture.
First, the government decided to ease key regulations in the biohealth sector, which is considered a new growth engine. It will revamp the authorization and review process so that safe therapies can be launched faster than anywhere else in the world.
Currently, a small number of reviewers examine massive authorization data sequentially by authorization requirement in biohealth reviews. There are concerns that verifying the safety and efficacy of new substances and turning them into products takes a long time. An industry official on site said, "In the global market, speed is competitiveness, but domestic authorization reviews take a long time."
In response, the government decided to shift to simultaneous and parallel reviews by innovating the authorization and review process. It also set a specific goal of completing new drug approvals within 240 days.
Restrictions on stem cell treatments in Korea will also be significantly eased. In Feb., the Advanced Regenerative Bio Act was revised to allow stem cell treatments, but under the current law the scope of treatment is limited to serious, rare, and intractable diseases. The definition of intractable diseases is even unclear, making it difficult to apply for treatment.
Accordingly, the Ministry of Health and Welfare plans to prepare guidelines within the year to flexibly determine on a case-by-case basis whether a disease is intractable and to allow treatment for major diseases that drive overseas medical trips (such as chronic pain and musculoskeletal disorders). In addition, to revitalize clinical research for diseases with high demand, the government will lead research efforts, and if there is sufficient overseas clinical research, it will also prepare a plan to proceed directly to treatment review to promote treatment.
Siting regulations will also be improved to expand agrivoltaics.
Currently, agrivoltaics cannot be installed in agricultural promotion zones. Even for farmland outside agricultural promotion zones, the period of farmland use for solar power projects is limited to a maximum of 8 years. In addition, setback distances for solar facilities differ by local government, making it difficult to secure usable sites.
Accordingly, the government will revise the Farmland Act to allow power generation projects in agricultural promotion zones when designated as renewable energy districts. It will also extend the use period of agrivoltaic facilities installed on farmland from 8 years to 23 years. The government plans to revise the New and Renewable Energy Act to harmonize the setback distances for solar facilities set individually by local governments under a uniform standard.
Import regulations on waste resources will also be eased to secure key minerals such as lithium and rare earths. Under the current resource import system, corporations face strict import license reporting requirements when importing key minerals and a 3% import tariff. The government plans to simplify, by the first half of next year, the import procedures for waste resources used to extract key minerals, and to ease tariffs on waste resource imports by the first quarter of next year.
A government official said, "We plan to pursue preemptive and bolder rationalization of regulations to secure future sources of revenue and new growth engines."