COVID-19 Vaccine Manufacturers Allowed to Use Patient Data for Safety Investigations

[Image source=Yonhap News]

[Asia Economy Reporter Byun Seon-jin] The Ministry of Food and Drug Safety announced on the 15th that it has established procedures to allow pharmaceutical companies producing COVID-19 vaccines to use the 'real-world database'?patient information collected by hospitals and clinics?when conducting post-marketing surveillance. Post-marketing surveillance is an investigation conducted to observe new adverse events and gather information on safety and efficacy that were not identified during the drug approval process for new drugs currently sold in the market.

Since COVID-19 vaccines have been administered to many people over a short period, there is abundant information on safety and effectiveness, making post-marketing surveillance feasible. However, until now, the lack of procedures has made it difficult to use real-world data for COVID-19 vaccines. In response to these concerns, the Ministry of Food and Drug Safety pledged to improve this system in August as part of the '100 Major Regulatory Innovation Tasks for Food and Drugs.'

Accordingly, the Ministry of Food and Drug Safety, in consultation with the Korea Disease Control and Prevention Agency and the National Health Insurance Service, has established procedures for using the post-marketing database (pseudonymized information) for COVID-19 vaccines, which is expected to facilitate data utilization. When the Ministry reviews and approves the post-marketing database research plan submitted by a pharmaceutical company, the company sends a data utilization application to the Disease Control Agency and the National Health Insurance Service. After reviewing the application and deciding whether to release the data, the agencies provide the data to the pharmaceutical company, which can then conduct post-marketing surveillance using the received data.

The Ministry of Food and Drug Safety has published a guidebook on these procedures. The Ministry stated that it will continue to do its best to ensure the safe use of pharmaceuticals based on regulatory expertise.