The South Korean Ministry of Drug and Food Safety has come under fire for its lax management after it mistakenly publicized the official approval of a new drug that was still undergoing review on the ministry’s website.
On Wednesday, the Drug Ministry publicized on its website that it had granted approval to a new osteoporosis drug developed by Hanmi Pharmaceutical. The information was publicized by local news outlets.
Two days later, the ministry issued an official statement saying the information was mistakenly put up on the website due to a “procedural mistake,” and that the drug has not been approved and is still undergoing review by the ministry.
“We will closely examine our approval procedures so that nothing like this happens again in the future,” the ministry said in a statement of apology. The given information has been pulled from the website.
The incident has ignited concerns that the Korean drug regulator is taking lightly key factors that are critical to a pharmaceutical company’s business, including product approvals and clinical trials.
This is not the first time the Drug Ministry has had to retract information that it had mistakenly publicized. In August 2016, the ministry uploaded the wrong hospital information in detailing plans for a local biotech company’s phase 2 clinical trials, creating confusion.
Industry officials have pointed out that it is difficult to speak out against the Drug Ministry even when it makes flagrant mistakes, as the ministry has the upper hand in authorizing local clinical trials as well as new drugs.
By Sohn Ji-young (
jys@heraldcorp.com)
