The Bricks of Other Mountains: The Supply of More than 2,500 Generic Drugs in Japan Is Seriously Insufficient

Recently, there have been frequent problems of illegal production by pharmaceutical companies and CR.

On May 20, the EMA issued a notice saying that due to problems with the results of the trial data conducted by Synchron, it is recommended to suspend the marketing authorization of about 100 generic dru.

EMA pointed out that the main problem is that the quality and reliability of the data in the bioequivalence studies carried out by Synchron need to be examin.

The drugs are on hold until supporting data from more reliable sources are availab.

The forbearance is based both on the importance of the medicines and on the lessons learned from the shortages caused by the suspension, for which the EMA had to take special ca.

This lesson from the past, the brick of other mountains is Japan, the top student in the popularization of generic dru.

This lesson from the past, the brick of other mountains is Japan, the top student in the popularization of generic dru.

As of May 10, shipments of a total of 2,516 generic drugs were lagging, accounting for about a quarter of all generic dru.

After investigation, the shortage was mainly caused by the illegal production of generic drug manufacturers and orders to suspend business for rectificati.

The "Golden Decade" of Generic Drugs

The "Golden Decade" of Generic Drugs

Although the emergence of innovative drugs can meet new treatment needs and provide new treatment options, generic drugs are still the main force to ensure the basic drug needs of the masses, both at home and abro.

This phenomenon is more pronounced in Jap.

According to the report of the Ministry of Health, Labour and Welfare of Japan, the proportion of generic drugs in Japan was less than 30% in 2003, and rose to 59% in 2016, while the proportion of generic drugs in the United States, Germany, the United Kingdom, and France in the same period was 97%, 83%, and 76%, respective.

The proportions of generic drugs in the United States, Germany, the United Kingdom, and France were 97%, 83%, 76% and 66%, respective.

Figure 1: The proportion of generic drugs in Japan over the years

The measures to popularize generic drugs in Japan are similar to those in China, including carrying out the consistency evaluation of generic drugs, establishing a generic drug supervision system, and tilting generic drugs on the payment si.

As of 2020, the share of Japanese generic drugs rose to 7

The use of Japanese generic drugs saves about 1,291 billion yen in drug costs each year, or about 79 billion yu.

The period from 2007 to 2017 is often referred to as the "golden decade" for the development of generic drugs in Jap.

However, with the rapid development of the industry to a certain stage, the problems of low "ceiling" of generic drugs and lack of competition barriers are gradually exposed, and major generic drug companies are facing the dilemma of performance growth after rapid developme.

Winning or losing does not matter

Winning or losing does not matter

Nihon Yigong is a typical representative of generic drug companies taking advantage of the refo.

Around 2000, Nippon Medical Technology seized the policy dividend of popularizing generic drugs, strengthened its channel sales capabilities through mergers and acquisitions and expanded its own scale, and successively expanded overseas markets through alliance cooperation in the United States, Thailand and South Kor.

Nihon Yigong is a typical representative of generic drug companies taking advantage of the refo.

As of 2017, Nippon Medical Industry's revenue was 167 billion yen (about 5 billion US dollars), of which overseas markets accounted for 2
The company has 8 factories with more than 1000 produc.

At this time, Nippon Medical Technology has become the largest generic drug company in Jap.

Problems follow.

In the early days of the reform, Nippon Medical Engineering quickly gained technological, market and competitive advantages by merging small companies, but with the continuous progress of mergers and acquisitions, the concentration of the generic drug industry has become higher and higher, and the competition will eventually focus on the leading compani.

Everyone is strong, the shortcomings of generic drugs with low added value and undifferentiated competitive advantages are beginning to be exposed, the market growth is approaching the ceiling, the industry is facing a reshuffle, and the survival pressure of major generic drug leaders is intensifyi.

The shortcomings of generic drugs with low added value and undifferentiated competitive advantages have begun to be exposed, the market growth is approaching the ceiling, the industry is facing a reshuffle, and the survival pressure of major generic drug leaders has intensifi.

In March 2021, it was revealed that its first factory in Toyama, located in Namegawa City, Fujisan Prefecture, was found to be manufacturing drugs with an unapproved process, and within less than a year from April last year, Nippon Medical Industry has been self-sufficie.

75 kinds of medicines including anti-allergy, high blood pressure and diabetes were recover.

In less than a year from April last year, the Japanese medical workers have recovered 75 kinds of drugs including anti-allergy, high blood pressure and diabetes by themselv.

Relevant persons said that the main violation of Nippon Medical Engineering is to re-manufacture and sell medicines that fail the factory inspection through methods not allowed by the Japanese government, such as reprocessing and re-inspection, and this process has lasted for at least 10 yea.

Exploring the reasons behind the violations, people familiar with the matter said that with the rising demand for generic drugs, the production of Japanese medical workers increased rapid.

However, because the company's manpower and production equipment could not keep up, an excessive production plan was finally set, and the test fail.

The drug was not abandoned, but was tested again to make it "qualifie.

Excessive production plans are set, and drugs that fail the test are not abandoned, but are re-tested to make them "pas.

Such a behavior of "turning waste into treasure" is no longer a special case in Jap.

In February of this year, Kobayashi Chemical exposed a fraud scand.

The company has misused pharmaceutical raw materials, violated regulations in the pharmaceutical process, used yin and yang account books to cope with inspections, fabricated some quality inspection results, and still shipped after abnormalities were fou.

"8 major faults", nearly 80% of the drugs Manufacturing records are suspected of falsificati.

The successive illegal production has exposed the limitations of the development of generic dru.

There are about 190 generic drug manufacturers in Jap.

Since it is difficult for generic drugs to form a competitive advantage different from other manufacturers, generic drug manufacturers are more inclined to expand their competitive advantages by increasing the variety of products, but in terms of personnel and production equipment Under the constraints, increasing the variety is likely to lead to the production quality not keeping .

In order to ensure the supply of medicines and to win the competition at the same time, enterprises will not hesitate to take risks and process substandard medicines before selling th.

Generic drug manufacturers are more inclined to expand their competitive advantage by increasing the variety of products,

In response to the current shortage, Japan's Ministry of Health, Labour and Welfare has asked manufacturers to increase producti.

Two large generic drug manufacturers, Sakai Pharmaceutical and Towa Pharmaceutical, have announced large-scale production increas.

However, it is estimated that it will take about 2 years to add factories and obtain approval from the Japanese government, and the current situation of insufficient supply of pharmaceuticals cannot be eliminated in the short te.

The current situation of insufficient supply of pharmaceuticals cannot be eliminated in the short te.

summary

summary

The rapid development of generic drugs and corporate fraud cannot be equat.

However, behind the chaos in the industry reflects the development bottleneck of generic dru.

How to see the big from the small and make effective breakthroughs is the focus of the government and enterprises in the futu.

The rapid development of generic drugs and corporate fraud cannot be equat.

However, behind the chaos in the industry reflects the development bottleneck of generic dru.

How to see the big from the small and make effective breakthroughs is the focus of the government and enterprises in the futu.

Focusing on China, China's generic drug industry is still in the early stage of small, miscellaneous and scattered, and will not encounter the problem of "development bottleneck" in the short term; Will some companies charge shoddy products in order to ensure supply?

This is a probability problem and must be prevented in advan.

The government and relevant procurement departments should strengthen supervision, strengthen drug quality inspections and unannounced inspections, and set up a corporate credit evaluation mechani.

Once discovered, they must be dealt with strict.

The government and relevant procurement departments should strengthen supervision, strengthen drug quality inspections and unannounced inspections, and set up a corporate credit evaluation mechani.

Once discovered, they must be dealt with strict.

Because this is not only related to the quality of a single drug, but also to the confidence of patients in domestic generic dru.

Although the consistency evaluation of generic drugs ensures the safety and effectiveness of domestic generic drugs, due to long-term concepts and some drug fraud incidents, patient confidence in domestic generic drugs still needs to be establish.

Once similar fraudulent incidents occur, drug safety will be "small" and the relationship between drug and patient will be estranged, which will affect the development of more generic drug companies and the indust.

Confidence of patients in domestic generic drugs is establish.