1488 drugs approved last year…30% diabetes drugs

MFDS Releases 2023 Drug Approval Report

No. of approvals: Diabetes drugs>Antipyretic, analgesic, anti-inflammatory drugs>Other vitamin drugs

No. of orphan drug approvals tripled from 2019...maybe due to pharma industry’s increased investment

A total of 1488 drugs were found to be approved by the Ministry of Food and Drug Safety last year.

 

The MFDS said on the 30th that it published the Drug Approval Report that contains the approval, certification, and report status of drugs, quasi-drugs, and medical devices in 2023.

 

In the case of pharmaceuticals, a total of 1,488 items were approved, including 1,300 finished drugs, 49 APIs, and 139 herbal medicine ingredients.

 

Of the approved finished drugs, 884 (68%) were ETC drugs and 416 were OTC drugs.

 

Also, the number of orphan drug approvals increased continuously, and diabetes drugs accounted for the largest number of approvals among all finished drugs.

 

However, the number of generic drug approvals has steadily decreased after the ‘1+3 system’ was implemented.

 

In terms of the total number of finished drug approvals, diabetes drugs accounted for the largest number of approvals, totaling at 462.

 

This is more than 30% of all finished drugs.

 

This was followed by antipyretic, analgesic, and anti-inflammatory drugs (120 items), other vitamins (87 items), and blood pressure-lowering drugs (77 items).

 

In terms of synthetic drugs approved last year by type, 29 were new drugs, 22 orphan drugs, 390 data submission drugs (including 15 incrementally modified drugs), and 2 APIs.

 

The number of new drug approvals increased by about 50% compared to 2022 to 29 (5 manufactured and 24 imported), and the top efficacy categories by the number of approved items were nervous system drugs (7), diabetes drugs, and antineoplastic agents (6 each), circulatory system drugs and blood and body fluid agents, respiratory system drugs and allergy drugs (3 each).

 

In the case of orphan drugs, a total of 37 products that contain 26 ingredients were approved last year, an increase of 4 ingredients and 7 products from the previous year.

 

This is a threefold increase from 2019 (9 ingredients), which is likely due to increased industry investment and active government support for orphan drug development.

 

Of the 375 new data submission drugs, 50.4% (189) were submitted for new salts or isomers, followed by 24.5% (92) for new compositions, and 13.3% (50) for new dosage forms (with the same route of administration).

 

Looking at the types of incrementally modified drugs developed and approved in recent years, in 2016-2017, the development of combination drugs (drugs containing two or more active ingredients in a single product) with new active ingredient compositions was popular, and in 2018, 6 sustained-release drugs with improved dosing and dosage by reducing the number of required doses were approved.

 

Last year, a total of 15 products were approved, including 14 combination drugs with new active ingredient compositions and 1 product that improved utility by developing a product with different efficacy and effectiveness.

 

Last year, a total of 802 generic drugs were approved and reported.

 

Other drugs accounted for the largest share of generic drugs.

 

Also, 15 of the synthetic drugs among data submission drugs were recognized as incrementally modified new drugs.

 

Since July 2021, the number of applications for generic approvals decreased sharply until 2022 due to the implementation of the '1+3' system, which limits the use of the same clinical trial data to 3 times.

 

The number of applications in 2023 is on par with those in 2022.

 

A total of 929 quasi-drugs were approved and reported.

 

This was mainly due to the eased mandatory requirement and decreased wearing of masks, as well as the active development of quasi-drugs related to daily life, such as sanitary napkins, band-aids, and toothpaste due to the growing interest in health.

 

A total of 7065 medical devices were approved, certified, and reported, with an increase in ▲high-tech medical devices such as artificial intelligence-based medical devices and surgical rehabilitation robots.

 

Also, ▲ medical device software items are on the increase, and ▲digital treatment devices and heavy-ion particle therapy devices were introduced as new means of treatment.