An increasing number of pharmaceutical companies voluntarily canceled the license for their products in the first six months this year, apparently affected by the latest regulation mandating drugmakers to update clinical data to maintain drug approval.
According to the Ministry of Food and Drug Safety, drug companies sought voluntary license nullification on 1,583 medicines from January to June 25. The number is nearly three times more than 610 products in the same period last year.
Under the Pharmaceutical Product Approval Renewal System, a drug company has to submit data of the drug’s safety, efficacy and output five years after winning the drug license for the reassessment of the drug. The system aims to reduce medicines without production and enhance drug safety.
All drugs are subject to approval renewal except for raw materials and products for export. For license renewal, a drugmaker should submit data as following; safety management data and measures, data of overseas use and safety, quality control, labels, manufacturing and import data, manufacturing/sales/import license or a copy of the item registration.
Nullifications of the license of prescription drugs were twice those of over-the-counter medicines in the first half.
Out of the 1,583 medicines voluntarily withdrawn, 1,079 were OTC drugs, and the rest 504, prescription drugs. It means many OTC drugs were not produced or sold but had authorization only.
By company, C-Tri voluntarily withdrew drugs the most, canceling 61 items, and Daewoong Pharmaceutical, 55.
To prevent the license renewal of drugs that are produced but not sold, the ministry will reflect drug insurance claims during license renewal review.
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