South Korea
The Pink Sheet looks at what major policies and regulations South Korean authorities prioritized in 2024 and what may be in store for this year.
Speedier approval of clinical trials, flexibility towards new technologies, faster access to new drugs and lingering regulatory barriers to decentralized trials are among the challenges South Korea is facing in becoming a global trial hot spot.
A short-lived but shocking attempt to declare martial law by South Korea's president has thrown the country into political turmoil which could disrupt foreign biopharma investment and key policy initiatives.
The head of the Korea Regulatory Science Center talks exclusively to the Pink Sheet about why regulatory science is crucial, the country's efforts to improve in the area and the center's strategic bridging role.
A session at the recent KoNECT conference in Seoul looked at Korea’s strengths in clinical trials but also at what's needed to further improve its global competitiveness as a location for studies.
The five-year roadmap aims to expand support for AI research and development in essential health care and new drug development, as well as advance medical data usage systems and enable its safe use.
Under the new drug approval innovation measures, Korea will cut the review and approval period of new drugs to 295 days from 420 days and increase the number of expert reviewers to enhance review capabilities.
South Korea has yet to come up with detailed plans for a major national biopharma cluster, but is considering a virtual approach to connect existing industry hubs nationwide. At a recent policy forum, experts discussed related issues including governance and insufficient investment, as well as the need to attract foreign firms and capital to compete with rival clusters in Asia.
South Korea is set to provide an additional $18m in support to CEPI amid heighted global worries over mpox. The coalition's CEO and Korea's foreign minister met to discuss strengthened collaboration to prevent and respond to any future pandemics.
Long-running protests by South Korean doctors against government reforms, including raising medical school admissions, continue to intensify with a one-day rally by community doctors and the threat of an indefinite walkout later this month. The pharma industry is also feeling the impact on clinical trials and sales.
South Korea’s clinical trial approvals rebounded in 2023, but remained lower than the peak levels in 2020-21 amid then robust R&D activity related to COVID-19. Last year's tally showed a mix of single-country and multinational trials and reflected the ongoing dominance of oncology in industry pipelines.
The US Food and Drug Administration and the European medicines regulatory network, which includes the European Commission, the European Medicines Agency and 30 national agencies, are now WHO-Listed Authorities under a framework launched in 2022.
The EU and Korean authorities say the agreement will allow them to further develop moves towards mutual recognition and regulatory harmonization.
Experts discussed regulatory science issues at a recent forum in South Korea, including the responsibilities of sponsors and regulators as well as the need to strengthen collaborations and accelerate the development of innovative drugs and converged medical products.
Notable new drug approvals in South Korea last year included Pfizer’s Tukysa, Genentech’s Columvi and BeiGene’s Tevimbra, but the tally did not include any domestically-originated products. Alzheimer’s disease therapy lecanemab may be on the horizon this year.
During the first international symposium on the use of AI in medical products, co-hosted by US and Korean regulators, global experts discussed issues and challenges related to effective development and regulation. Cooperation, flexibility and the need for a "human-centric" approach emerged as key themes in the fast-moving field.
A new agreement signed between Singapore’s Health Sciences Authority and South Korea’s Ministry of Food and Drug Safety means drug manufacturers in the two regions will be subjected to fewer duplicative good manufacturing practice inspections.
South Korea’s healthcare services face both longer-term systemic challenges and short-term disruption from ongoing doctor walkouts over government plans to boost medical trainees. Meanwhile, the local pharma industry is calling for new measures to support the supply of essential drugs.
Steps to foster the biopharma industry, a regulatory science innovation law and a new pan-government policy control tower were among the highlights of policy and regulatory activity in South Korea in 2023 set to have an ongoing impact throughout this year.
A policy report by a major South Korean pharma industry association puts forward suggestions on what it will take for a new pan-government control tower to function properly.