Financial Services Commission: "Detailed Disclosure Required for Clinical Trial Matters of Pharmaceutical and Bio Companies"

Published 09 Feb.2020 12:54(KST)

[Asia Economy Reporter Park Jihwan] In the future, companies engaged in pharmaceutical and bio businesses will be required to disclose specific details about important management activities such as clinical trials, product approvals, and technology transfer contracts.

The Financial Services Commission and Korea Exchange announced on the 9th the release of the "Comprehensive Disclosure Guidelines for Pharmaceutical and Bio Industry Companies," which include these requirements.

Pharmaceutical and bio companies must now provide detailed disclosures regarding important management activities such as clinical trials, product approvals, technology introduction and transfer contracts, government-funded projects, and patent contracts.

For clinical trials, companies must inform investors specifically about the planning, application, results, suspension of trials, drug usage prohibition measures, trial termination, and outcomes. In particular, for product approvals, disclosures must cover applications and results, cancellations, sales and distribution prohibition measures, and judgments of non-compliance with Good Manufacturing Practice (GMP) standards.

Additionally, items requiring detailed disclosure include license contract signings related to technology introduction and transfer, contract terminations due to clinical trial discontinuation or product approval denial, selection for important government-funded projects related to key technologies, acquisition of significant patents, and patent transfer contracts.

Model disclosure formats will be provided for major disclosure items, and cautionary statements must be included to ensure investors fully understand and assess related risks. Uncertain information that could cause confusion in investment decisions, such as promotional content, will be restricted from disclosure.