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According to the announcement of the State Food and Drug Administration, as of December 31, 2013, of the 1,319 sterile pharmaceutical manufacturing enterprises in the country, 796 companies had passed all or part of the workshop certification, accounting for 60.3%.
According to the announcement, as of January 1, 2014, aseptic pharmaceutical manufacturers or production plants that have not passed the new version of GMP certification will stop production. After an enterprise ceases production, if it completes the new version of the drug GMP reform, it can continue to apply for certification; enterprises that abandon the certification can withdraw in an orderly manner through independent selection of technology transfer of varieties, merger and reorganization of enterprises.
The high cost of upgrades Most of the companies that pass the new GMP certification are large companies. Small businesses do not pass much because the cost of the renovation is not a small number for the company. â€
Statistics show that in the last round of GMP certification, a total of 3,959 manufacturing companies passed the total cost up to more than 150 billion yuan, and about 1,400 companies that failed the GMP certification were eliminated.
The relevant person in charge of the Drug Safety Supervision Department of the State Food and Drug Administration had publicly stated that it is expected that the company will comply with the new regulations and that only the total hardware investment will require 200 billion to 300 billion yuan.
The new version of GMP certification requires higher hardware requirements and more stringent air purification standards and cleanliness standards for aseptically produced drugs. This time the standard is relatively high and it has reached the level of the European Union. Therefore, enterprises need large investment in transforming their equipment.
In addition to the high hardware requirements, the new version of GMP also adds requirements for risk management systems, design verification systems, job training systems, change control systems, and deviation handling.
Small and medium-sized pharmaceutical companies are in a very embarrassing situation. They are not willing to withdraw from the market, and they cannot afford to renovate. GMP certification is a barrier to entry, companies will try their best to pass the certification, small businesses want to spend the least money to pass certification, and the local government will not watch these companies die, often do some workarounds.
The problem of overcapacity for small companies or companies has always been plagued by the problem of the pharmaceutical industry. Due to the low entry thresholds for old GMP certification and the small, chaotic and scattered phenomenon of pharmaceutical companies, the phenomenon of overcapacity in the sterile pharmaceutical market is equally serious. The competition of similar products is fierce, and the process and technology are often closed.
In recent years, the incidence of adverse reactions of aseptic drugs in the clinic has been high. Generally, allergic reactions are manifested. In severe cases, shock or even death may occur. These adverse events, in addition to the physical factors of individual patients, are closely related to the quality of medicines.
According to an announcement by the State Food and Drug Administration, only 60.3% of the aseptic drug manufacturers have passed GMP certification, but the total production capacity has reached more than 160% of the market's actual demand in 2012 and can meet market supply. The problem of excess capacity is evident.
Even without this round of new GMP requirements, there is a group of aseptic manufacturers that are facing elimination. In terms of production capacity and utilization of Chinese medicines, powder injections in sterile preparations are the lowest. With a utilization rate of 27% and a surplus of 73%, it is the formulation with the largest capacity, the highest excess ratio, and the lowest utilization capacity among many types of formulations.
Foreign companies are committed to independent research and development. There are not many manufacturers of the same product, and they are basically generic drugs in the country. The technology can't be separated by gaps, so companies can only fight costs.
According to industry sources, some small businesses are forced to take risks through competitive pressures. Some companies only put some production lines into production through GMP certification, and even several companies share a drug lot number.
Some small companies have become destabilizing factors in the pharmaceutical market. Vicious competition is serious. The new version of GMP certification allows companies that do not meet the regulations to withdraw from the market and ease the situation of overcapacity, which is conducive to fair competition.
New version of GMP renovation costs high or make small businesses take risks
The advent of the new version of the GMP "test" has made every drug company nervous. GMP is a set of mandatory standards applicable to pharmaceuticals, foods and other industries. It requires companies to meet hygiene quality requirements in terms of raw materials, personnel, facilities and equipment, production processes, packaging and transportation, and quality control in accordance with relevant national laws and regulations. In other words, GMP certification is a threshold for pharmaceutical companies.