The effect of government regulation

Approximately 7,000 Rx drugs market has been withdrawn in 3 years

Last year, 2,167 market withdrawals, including withdrawal and cancellation of Rx drugs permits, etc.

More than 2,000 perished for 3 consecutive years

More than 7,000 Rx drugs have withdrawn from the market over the past 3 years, the report showed.

 

It is analyzed that this is due to the fact that the item license renewal system, which regularly checks the safety and efficacy of drugs, has been established and a series of market withdrawals due to continuous clinical re-evaluation.

 

Some point out that the government's pressure to re-evaluate generic drug prices also encouraged the market to withdraw.

 

According to the Ministry of Food and Drug Safety on the 11th, a total of 2,167 cases were withdrawn from the market last year, including the withdrawal and cancellation of Rx drugs.

 

The number of Rx drugs permits was 93.8% higher than 1118.

 

This means that there were about twice as many professional drugs in which market withdrawals entered the market as new markets last year.

 

The number of withdrawals and cancellations of Rx drug licenses surged 68.1% from 1,600 in 2019 to 2,690 in 2020.

 

In 2021, 2,595 Rx drugs were withdrawn, and more than 2,000 Rx drugs disappeared for the third consecutive year until last year.

 

A total of 7452 Rx drugs have been withdrawn from the market over the past three years due to the withdrawal and cancellation of permits.

 

A total of 3,796 Rx drugs returned permits over the three years from 2017 to 2019, with the number of products withdrawn from the market doubling over the next 3 years.

 

It is analyzed that the number of products disappearing from the market has increased due to the combination of government regulatory movements such as drug item license renewal, clinical re-evaluation, and price of generic re-evaluation.

 

It is pointed out that the withdrawal of expired drugs from the market has increased due to the establishment of the item license renewal system.

 

The key to the drug item renewal system, which was based on the revision of the Pharmaceutical Affairs Act in 2012, is that drugs approved by health authorities must be re-certified every five years to maintain their licenses.

 

Existing drugs on the market have been verified for safety and efficiency once every 16-20 years through a procedure called reevaluation.

 

However, the renewal system was introduced because it was deemed necessary to operate a reasonable evaluation system according to rapid scientific development.

 

Drugs licensed from January 1, 2013 are maintained only after submitting data related to safety and efficacy every five years and being judged suitable by the Ministry of Food and Drug Safety.

 

If a drug whose item license expires does not submit data for renewal, the license will be canceled.

 

An industry official explained, "After the implementation of the item license renewal system, even if there are no safety and efficiency problems, the practice of withdrawing products with low sales volume from the market has been established." The government's continuous revaluation policy is also cited as a factor that accelerates the product cleanup phenomenon.

 

In the case of clinical re-evaluation, which rechecks efficacy and safety, it often leads to the withdrawal of the drug from the market.

 

For example, in the case of Choline alfoscerate, a brain function improvement drug, more than half of the licensed products left with the start of clinical re-evaluation.

 

In June 2020, the Ministry of Food and Drug Safety requested the submission of clinical trial data for Choline, and 57 pharmaceutical companies were approved for re-evaluation clinical plans.

 

Initially, the Ministry of Food and Drug Safety ordered a total of 134 companies to re-evaluate Choline's clinical trials, but less than half of 57 companies were approved for re-evaluation clinical trial plans.

 

This means that 77 companies gave up the re-evaluation of Choline and chose to withdraw from the market.

 

Recently, some diagnose that the withdrawal from the Rx drug market has increased due to the re-evaluation of generic drug prices.

 

In June 2020, the Ministry of Health and Welfare announced a plan to reevaluate the upper limit of drugs that maintain the previous drug price if Generic, which does not meet the highest price requirements, submits BA test and registered raw material drug data by February 2023.

 

The re-evaluation of the generic drug price is a policy to apply the new drug price system, which took effect in July 2020, to the original generic.

 

Each time one requirement is not met, the upper limit is lowered by 15%.

 

Pharmaceutical companies should choose strategies to accept drug price cuts for consignment generics or avoid drug price cuts through additional investments.

 

Requirements for the use of registered raw materials can be met through the replacement of raw materials and medicines.

 

Pharmaceutical companies are in a situation where they have to choose between accepting drug price cuts or maintaining drug prices through conducting BA tests.

 

Accordingly, pharmaceutical companies are actively conducting BA tests on licensed generics.

 

The goal is to avoid lowering drug prices through permission to change the drug price by making generics through pharmaceutical research, conducting BA tests, and obtaining equivalent results.

 

At this time, if the permission is changed while converting consignment manufacturing to its own manufacturing, the company is using a strategy that meets the requirements for 'BA test implementation'.

 

For pharmaceutical companies, if additional investment is burdensome, they have no choice but to accept a reduction in drug prices.

 

It is known that many generics often choose to withdraw from the market rather than accept drug price cuts.

 

Some analysts say that reckless entry into generics, which did not take into account marketability before the government tightened regulations on generics, may have led to a withdrawal from the market after stricter regulations.

 

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 generics crisis.

 

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

 

The number of Rx permits reached 1,562 in 2018, which surged to 4,195 and 2,616 in 2019 and 2020, respectively.

 

374 of the Rx licensed in 2019 returned their permits.

 

In other words, it withdrew from the market less than three years after it was approved by the government's move to tighten regulations.

 

There are also more products that disappear from the market due to unexpected variables such as impurities.

 

The Ministry of Food and Drug Safety decided in September 2019 to ban the sale of all products containing Ranitidine, citing excessive detection of NDMA, a carcinogenic substance.