The Pink Sheet takes an infographic look at South Korea's clinical trial trends in 2022 to illustrate how the country's biopharma R&D is developing and how activities are recovering in the post-pandemic situation. One key takeaway is that approvals for trial starts have fallen back to pre-COVID levels, suggesting a falling off of activity related to drugs and vaccines for the virus.
The number of clinical trial approvals across all development phases in South Korea in 2022 sank to the level of before the COVID-19 pandemic in 2019 - but despite the drop, the country’s global ranking in terms of number of such permissions improved a notch, marking its best-ever placing.
According to the Ministry of Food and Drug Safety’s data for clinical trial approvals during the calendar year, the country...
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.
