MFDS Publishes Compilation of Improved New Drug Approvals Including 6 Items from Last Year

47 Circulatory System Drugs... Account for 40% of the Total

[Asia Economy Reporter Kim Ji-hee] Among the 118 improved new drug items, including 6 items approved last year, circulatory system drugs such as antihypertensives and anti-atherosclerotic agents accounted for the largest proportion with 47 items.

The Ministry of Food and Drug Safety announced on the 25th that it has published a revised edition of the "Improved New Drug Approval Casebook," which contains detailed information on the status of improved new drug items approved from 2009 to 2020. According to the casebook, approvals by therapeutic category showed that circulatory system drugs accounted for 47 items, nearly 40% of the total. This was followed by 16 items for diabetes drugs, 7 items for other metabolic drugs, 7 items for allergy drugs, and 7 items for blood and body fluid drugs.

Looking at the approved improved new drugs by type, prescription drugs with different types or combination ratios of active ingredients accounted for the highest proportion at 61% (72 items), while prescription drugs with the same active ingredients and administration routes but improved formulations resulting in different dosage forms, contents, or usage/dosage accounted for 28.8% (34 items). All 6 improved new drug items approved last year fall into these two types.

An official from the Ministry of Food and Drug Safety stated, "Following the publication of the ‘2020 Approval Report’ last month, we expect that the revision and distribution of the ‘Improved New Drug Approval Casebook’ will help the pharmaceutical industry in developing improved new drugs," adding, "We will continue to provide relevant information to encourage research and development of new products in the pharmaceutical industry."

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