Rx Drugs permits have fallen by 73% in 3 years

All-out regulatory fallout

Last year's Rx drugs permit was 1,118, ↓30% year-on-year

3,077 down from 4,195 in 2019

Stair-type drug price systems and joint development regulations have dampened the entry power of generics Last year, the number of Rx drug permits decreased significantly.

 

The number of market entries has been reduced by more than 70% compared to three years ago.

 

Analysts say that the government's all-around regulatory pressure, such as the reorganization of the drug price system and regulations on joint development, has greatly reduced its entry into the generic market.

 

According to the Ministry of Food and Drug Safety on the 9th, a total of 1,118 Rx drugs were approved last year.

 

It decreased by 30.1% in a year from 1,600 in 2021.

 

Last year, the number of Rx drug permits was less than half of the 2616 two years ago.

 

Compared to 4,195 in 2019, it decreased by 73.3%.

 

The number of Rx drug permits has decreased by 3077 compared to three years ago.

 

The number of Rx drug permits averaged 130 per month to 1,562 in 2018, but more than doubled to 4,195 per month in 2019.

 

In May 2019, 584 professional drugs were approved for a month.

 

However, since 2020, the number of Rx drug permits has gradually decreased and seems to have regained the previous year's level.

 

From October 2018 to July 2020, more than 100 Rx drugs were poured out every month, and in August 2020, Rx drug permits fell to less than 100 in 23 months.

 

Last year, there were only four Rx drug licenses per month.

 

It is analyzed that the number of generic permits, which account for the largest proportion of Rx drugs, has decreased.

 

The reorganization of the drug price system is cited as a major factor in the decrease in the number of generic permits.

 

The key to the revised drug price system, which took effect in July 2020, is to maintain the upper limit of 53.55% of the original drug before the expiration of the current patent only when generic products meet both the direct BA test and the use of the registered raw drugs.

 

The reorganized drug price system includes a stepped drug price system in which the upper limit decreases as the salary registration period is delayed.

 

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

 

Analysts say that the permission for the entire process of manufacturing consignment generics has decreased significantly due to the structure in which drug prices fall significantly if pharmaceutical companies do not develop generics themselves and conduct BA tests.

 

Since more than 20 generics have already entered most markets with high marketability, late generics will inevitably lose their motivation to enter new markets as drug prices fall significantly due to the application of the step-type drug price system.

 

Some say that regulations on the joint development of drugs, which took effect in July last year, have promoted the decline in generic permits.

 

The revised Pharmaceutical Affairs Act, passed at the plenary session of the National Assembly in May last year, calls for limiting the number of improved new drugs and generics that can be approved as a clinical trials.

 

If all manufacturing processes are manufactured the same way with the same prescription and manufacturing method at the same manufacturing plant as the pharmaceutical company's drug that directly conducted the BA test, the use of BA data is limited to three times.

 

This means that only four generics can be approved for one BA test.

 

Clinical trial data can also be agreed to only three items other than drugs from direct-performing pharmaceutical companies.

 

In the past, dozens of pharmaceutical companies often received consignment generic licenses with the same data if certain pharmaceutical companies were approved for generics through BA tests, but joint development regulations have made it impossible to "unlimited generic replication." Critics point out that the government provided the cause of the surge in Rx permits in 2019 and 2020.

 

The government's move to tighten regulations on generics has led to a surge in generics permits.

 

In 2018, 175 items containing valsartan, a hypertension treatment, were banned from selling due to the detection of excess impurities.

 

At that time, the Ministry of Health and Welfare and the Ministry of Food and Drug Safety set up a "consultative body for improving the generic drug system" and began to come up with measures to curb the generic crisis.

 

As the government's move to tighten regulations showed, pharmaceutical companies moved to install generic products in advance, temporarily increasing generic permits.

 

The number of generic permits surged due to the government's move to tighten regulations and returned to the previous level after the system was reorganized.