South Korea's 5-year plan to advance clinical trials a boon for US biotech

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/Bobtokyoharris)
(Image: Getty/Bobtokyoharris)

Related tags: Novotech, South korea

South Korea looks to accelerate review timelines and study start-up with a new five-year plan that will benefit biotechs looking for locations outside the US to ‘ramp up’ clinical development programs, says CRO.

South Korea recently launched a five-year plan​ to advance clinical trials and boost the country’s status as a research destination regionally and abroad.

The Australia-headquartered contract research organization (CRO) Novotech, which has offices in Seoul, South Korea, and across the Asia-Pacific region, cites several key points in the new plan that it says will be of interest to US biotech clients.

Among the proposals include the hiring and development of teams – including a new Clinical Trial Review Division – to streamline investigational new drug (IND) review and submission.

“The new bill is expected to reduce review timelines and accelerate study start-up,”​ a Novotech spokesperson told us.

According to the company, a preliminary review system will be established to review clinical trial applications with the goal of providing a response within 15 days for the initial assessment, and 20 days for final feedback.

Said the spokesperson, “This is of particular interest for US biotechs looking for alternative locations outside of the US to ramp up their clinical development programs.”

Good laboratory practice (GLP) data from non-OECD countries, such as China, also will be accepted moving forward, “as long as the company can provide strong and credible data through a fact-finding study which is similar to the systems the US and Europe have​."

The announcement of the five-year plan comes on the heels of a government bill released in May 2019, including plans to double R&D spending in the biotech sector by 2025 and other initiatives to reduce regulatory barriers, according to the company.

“The country has globally recognized key opinion leaders and well-established clinical trial centers with top-class infrastructures,”​ the spokesperson added, noting that some of the largest sites in South Korea, such as the Asan Medical Center, the Samsung Medical Center, and the Seoul National University Hospital each currently have more than 400 ongoing trials.

“This drives an increasing interest from western biotechs to conduct clinical trials over there,"​ they said. "In fact, it is estimated the clinical activity of US and European biotechs in South Korea has increased by about 15% in 2018​."

Expanding to its partnership program in South Korea earlier this year​, Novotech signed on two major hospitals, including Ulsan University Hospital (UHH) and Seoul National University Hospital (SNUH) Hepatology Division, with 900 and 1,778 beds, respectively.

The deal expanded Novotech’s program with up to 4m patients, according to the company, which has grown its Seoul-based team by more than 25% over the last year.

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