The government will not allow renewal of drug approval if a company manufactures medicines only to maintain the license without sales.
|Lee Dong-hee, director general of planning and coordination bureau at the Ministry of Food and Drug Safety, talks about new license renewal rules, at a news conference in Osong, North Chungcheong Province, on Monday.|
Lee Dong-hee, director general of planning and coordination bureau at the Ministry of Food and Drug Safety, said that the ministry would consider a drugmaker’s insurance claim records when reviewing a renewal of approval for medicine, at a news conference in Osong, North Chungcheong Province, on Monday.
For a drug approval renewal, a pharmaceutical firm submits data, including the safety and efficacy of the drug and output results five years after obtaining the nod for the drug. The government introduced the rule in 2013 and applied it in 2018.
All pharmaceutical products are subject to the renewal of approval, except for raw drug materials and items for exports.
The data required for the renewal includes safety management data and action plans, information of overseas use, and safety data and response records, quality control data, labeling, records of manufacturing and import, manufacturing and sales and/or import license and a copy of the item declaration.
The ministry said it would toughen the rule to reduce the number of drugs without production and enhance drug safety.
Some pharmaceutical firms intentionally kept drug items without production because they wanted to sell the drug license or re-market the item later in the future.
“Our initial plan was to exclude medicines without production from approval to reduce the number of drug items. However, some firms manufactured a small number of drugs to maintain the sales license but did not seek insurance claims,” Lee said. “If we reflect insurance claims when we review the renewal of the drug, we will be able to make our policy more effective."
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