South Korea’s Second Vice Minister of Health and Welfare Minsoo Park talks to the Pink Sheet about a broad range of issues including the government’s priorities for innovative R&D, as well as challenges in reaching these goals, measures to deal with the deterioration in biopharma investment sentiment and regulatory changes to support drug development.
South Korea is aggressively fostering its biopharma and health-related sectors, looking to grow these into national flagship strategic industries. The country is seen to have outstanding talent in the area, along with strong information and communications technologies to support medical data-based innovation.
The government has been steadily releasing since last year a series of policy steps along these lines, including market creation...
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.
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.
Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.
The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
