At a recent forum organized by South Korea’s drug ministry, participants discussed why a regulatory science-based approach is needed, what issues in this area are being faced by the country and which directions it should be headed.
With the increasing introduction of new innovative medical products including digital therapeutics amid intensifying competition among countries to rapidly secure new technologies, South Korea is feeling the urgent need to shift its focus more to a regulatory science-based approach.
Regulatory innovation is already a key part of the government's broader steps to accelerate investment and grow the biopharma sector,...
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.
