↓generic's approval as the drug price system is implemented

Less than 100 generic licenses in June/July

An average of 323 licenses per month has been granted since last year

The number of approval for generic drugs has declined for the second consecutive month.

 

If the bioequivalence test is not performed, the new drug price system, which gives low drug prices, was implemented, and greatly reduced the number of new licenses for authorized generics.

 

Some point out that the government's move to strengthen generic regulations has caused an unprecedented confusion as pharmaceutical companies have already installed as many generics as possible.

 

According to the MFDS on the 13th, a total of 70 generic prescription drugs were approved last month.

 

Following 73 in June, it fell short of 100 for the second consecutive month.

 

The number of generic licenses recorded more than 100 for 17 consecutive months from January last year to May this year.

 

During this period, an average of 323 new generics per month were granted.

 

In May of last year, 560 generics were licensed in a month, and more than 200 new generics were launched every month this year.

 

In May, 412 generics were licensed, but from June the number of licenses dropped significantly.

 

Number of generic licenses per month (Unit: number, Source: The MFDS)

Since last year, intensive licensing of generics is due to the government's move to strengthen regulations.

 

This is because it tried to get as many generics as possible before the regulation was strengthened.

 

.The new drug price system, which was implemented from this month, is pointed out as a factor in the surge in generic licenses

 

.Generic products must meet both the direct bioequivalence test and the use of the registered drug substance to maintain the 53.55% upper limit price compared to the original drug before the current patent expiration

 

.Whenever one requirement is not met, the upper limit goes down by 15%

 

.If one of the two requirements is satisfied, the upper limit is lowered to 45.53%, and if there is no satisfaction requirement, the upper limit is lowered to 38.69%

 

.The reorganized drug price system includes a stepped drug price system in which the upper limit is lowered as the time for registration of benefits is delayed

 

.If more than 20 generics are listed in the specific ingredient market, the upper limit of the newly listed item will be up to 85% of the existing lowest price

 

.It is pointed out that the Ministry of Food and Drug Safety's move to tighten regulations on permits has also encouraged the approval of a bunch of generics

 

.In April of last year, the MFDS announced a reinforcement of regulations on joint bioequivalence test through a partial amendment to the “Regulation on Pharmaceuticals Approval, Notification and Review”

 

.This is the content of limiting the number of consigned manufacturers to one original manufacturer

 

.Although the reinforcement of joint bioequivalence test regulations was not initiated due to the recent recommendation of the Regulatory Reform Committee of the The Office for Government Policy Coordination, the number of applications for generic licenses increased significantly shortly after the plans to strengthen bioequivalence test regulations were revealed earlier last year

 

.According to the MOHW, the previous drug price system is applied to products applied for benefit registration in May

 

.Generics, which have been approved since June and applied for reimbursed registration, are said to receive low drug prices by applying the new drug price system

 

.Even if both the bioequivalence test and the requirements for the registered drug substance are satisfied, the price of the drug is further reduced as the stepped drug price system is applied

 

.This is the background of the sharp decline in the number of new generic licenses from June

 

.

# of authorized generics licenses to all processes per month

Since June, the number of generics licensed through the entire process consignment method has decreased significantly

 

.The number of commissioned generics licensed in June and July was 39 and 42, respectively, which was less than 20% of the average of 273 from January to May this year

 

.Last year, a total of 3173 new generics were entered

 

.This means that an average of 264 commissioned generics per month poured out

 

.The proportion of authorized generics to the total number of generic licenses is also on a decline

 

.Among the new licensed generics in June and July, the proportion of authorized generics was 53% and 60%, respectively

 

.From January to May, authorized generics accounted for 84% of licensed generics

 

.Last year, the proportion of authorized generics reached 82%

 

.It is interpreted that the number of attempts to enter new markets decreased as authorized generics could no longer receive high drug prices due to the implementation of the new drug price system

 

.As pharmaceutical companies have been intensively licensed for generics within a short period of time, the number of areas for further entry has greatly decreased

 

.Most of the generics that pharmaceutical companies could sell before the tightening of regulations were granted

 

.The number of generics licensed for last year is more than five times that of 741 in 2018

 

.Recently, pharmaceutical companies have tried to apply the previous drug price system for the last time

 

.From January to May this year, around 300 drugs were newly listed on the reimbursed list each month

 

.Following 558 drugs in June and 653 in July, 836 products were newly added to the list in August

 

.That's about 2,000 in three months

 

.It is an unprecedented generic listing in the government's regulatory reinforcement movement in the market.