In the wake of the recall of cell gene therapy Invossa-K, the Ministry of Food and Drug Safety conducted a special inspection of six cell therapy developers. The raid came less than a year since the regulator made an urgent inspection in October last year.
According to industry sources, the ministry started the inspection in early September to enhance the regular monitoring after the cancellation of the Invossa license.
In October last year, the ministry had a special inspection of four cell therapy makers, suspecting that the companies poorly managed allogeneic cell therapies.
Some observers questioned the effectiveness of the inspection because the raid last year could not detect any problem in Kolon Life Science’s management of cell therapy Invossa.
However, six months after the inspection, Kolon found that Invossa contained a cell ingredient different from the authorized label.
If another company has a similar problem, the ministry will find it difficult to identify it even if it carries out an inspection, observers said.
“When the ministry had a pharmacist inspection last year, Kolon Life Science had no problem. The government must have been hard to know the mislabeling of Invossa because such pharmacist inspection was based on the data provided by the company,” an official at a cell therapy developer said.
The Invossa recall has also toughened regulations on cell therapies. The food and drug safety ministry revised the “Regulation on Approval Review for Biologic Products” on Sept. 9 to make cell therapy developers mandatorily submit the results of Short Tandem Repeat (STR) testing when seeking approval for cell and gene therapies.
The new rules came after Kolon Life Science said the company belatedly found the mislabeling because it had never conducted STR testing before it applied for the Invossa license.
“The government indeed tightened the control over cell therapies and related rules after the Invossa recall,” an industry source said. “The government is inspecting other companies belatedly, however, as it did so last year.”