MFDS to recruit 18 clinical doctors to "strengthen review expertise"

[Asia Economy Reporter Cho Hyun-ui] The Ministry of Food and Drug Safety announced on the 16th that it has fully staffed 18 clinical physicians this year to strengthen the expertise in clinical trial reviews for the approval of pharmaceuticals and medical devices, including treatments for the novel coronavirus infection (COVID-19).

Clinical trials are the stage where the safety and efficacy of pharmaceuticals and medical devices are confirmed through patients and others. Therefore, the role of clinical physicians with medical expertise in diseases and patient characteristics is essential.

The number of clinical physicians at the Ministry of Food and Drug Safety had been around 10, but last year, a dedicated task force (TF) for clinical reviews was formed to remove departmental barriers and create an environment where reviews can be conducted according to physicians' specialties.

An official from the Ministry explained, "We were able to staff the physician positions this time through active recruitment efforts, including improving working conditions by establishing an office in the metropolitan area."

The Ministry particularly noted that the collaboration of review officers specializing in pulmonology and pediatrics played a significant role in drastically reducing the average review period for clinical trial plans of COVID-19 treatments and vaccines under development from 30 days to 5 days.

Director Lee Eui-kyung stated, “The clinical physicians hired this time are talented individuals with extensive clinical experience in university hospitals and pharmaceutical companies, and it is expected that the Ministry’s expertise in clinical reviews will be further strengthened,” adding, "We will continue to strive to increase the number of clinical physicians in the future."

This content was produced with the assistance of AI translation services.