Last Year, a Total of 1,636 Approved Pharmaceutical Products... 2 Domestic New Drugs

Last year, over 1,600 pharmaceutical products obtained approval from the Ministry of Food and Drug Safety. Among them, two were domestically developed new drugs, and 29 orphan drugs were also approved to expand treatment opportunities for intractable and rare diseases. By therapeutic effect, 'metabolic drugs' such as diabetes medications were the most numerous.

The first domestically produced COVID-19 vaccine, Skycovione Multi.

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On the 28th, the Ministry of Food and Drug Safety announced the publication of the "2022 Pharmaceutical Approval Report," which contains the status of drug approvals and notifications from last year.

A total of 1,636 pharmaceutical products were approved or notified last year. There were 30 new drug items (22 active ingredients), among which two were domestically developed new drugs: the COVID-19 vaccine "Skycovione Multi" (SK Bioscience) and a new diabetes treatment "Enblo Tablet" (Daewoong Pharmaceutical).

Twenty-nine orphan drug items (22 active ingredients) were approved. With the approval of various orphan drug items and ingredients, treatment opportunities have expanded for patients with rare diseases such as intractable leukemia and relapsing multiple sclerosis, who previously had limited medical access.

By therapeutic category, metabolic drugs ranked first with 629 approved items (43.3%) last year. They were followed by nervous system drugs, circulatory system drugs, and digestive system drugs in order of approval. This is presumed to be influenced by the expanding market, including the lowering age range of diabetes patients.

The number of approved or notified generic drug items was 804, which is about half compared to the previous year (1,614 items). This is interpreted as the effect of a policy that limits the number of items sharing the same clinical (bioequivalence) test data to three, following the revision of the Pharmaceutical Affairs Act.

The Ministry of Food and Drug Safety stated, "We will continue to utilize the analysis data of drug approval and notification status for policy formulation and support pharmaceutical product development through information provision."

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