2014 will surely become the new GMP large-scale transformation start year

According to the new GMP certification schedule, the “certification” door for sterile pharmaceutical manufacturers engaged in blood products, vaccines, and injections has quietly closed. According to the data as of the end of June 2013, only 329 of the 1,319 sterile pharmaceutical manufacturing enterprises in the country passed some or all of the new GMP certifications, accounting for 24.9% of the total; however, by the end of September 2013, the rate of adoption of sterile pharmaceutical manufacturers across the country was also It was only 29.7%; as of December 23, 2013, there were 597 companies that had passed the new GMP certification aseptic drug manufacturers, which accounted for only 45.3% of the total number of aseptic drug manufacturers.

From the published data, the 2013 new GMP certification situation is not only not ideal, but also slow. In addition to sterile drug manufacturers, the new version of GMP also stipulates that other drug manufacturers must pass certification by the end of 2015, otherwise it will be difficult to escape production stoppages. For the remaining two-year transition period, 2014 will surely become a large-scale start-up of the new GMP reform.

Based on the experience of the first version of GMP certification, the sooner the company successfully passed the certification, the more advantages it will have in sales bidding. Even if companies that have not passed the new GMP certification have expanded their production before the expiration of the deadline, they can store several quarters of their products and maintain their supply for a period of time, making the sales of GMP-certified companies unlikely to burst in the short term.

However, from the flexibility of the pharmaceutical market in 2014, the obvious benefit will be the relatively low-end varieties in the field of injections. For example, the market concentration of antibiotic injections such as Cologne Pharmaceuticals, China Resources Double Crane, etc. will be higher. The speed will be gradually released, which is not bad for companies that have passed the new GMP certification. Therefore, as long as there is a certain strength or ability of the company will implement the new version of GMP transformation as soon as possible, will not wait and see attitude in 2015 to apply for extension.

In addition, there are numerous pharmaceutical manufacturing enterprises in China, and the overproduction of pharmaceutical production capacity is relatively prominent. Taking a freeze-dried powder injection in a sterile pharmaceutical manufacturing company as an example, only 20% of companies that have passed the new GMP certification will be able to supply nearly 70% of the market demand. This fully illustrates the problems in the structure and production capacity of China's pharmaceutical industry. .

Moreover, for those companies that are below the survival line, due to lack of funds, they are unable to carry out new GMP reforms, or cannot independently research and develop new products due to their incompetence, as well as market expansion, channel network construction, etc., before the new GMP certification deadline, In order to revitalize aging assets, they have adopted methods such as document sales and land degeneration to obtain land dividends from industrial land to commercial land. At the same time, enterprises above the survival line also want to take advantage of this opportunity to “rob” and realize industrial layout. No. collection and storage. Under the condition that both parties have the same demand, the Chinese pharmaceutical industry in 2014 will inevitably have a large-scale merger and reorganization.

At the same time, the government should reduce administrative interference in the process of future mergers and reorganizations of companies that have passed the new GMP certification. The flaws and lack of serious laws and regulations in our country are only the basis, and failure to truly achieve law enforcement and strict compliance with the law is fatal. For China's pharmaceutical industry, the phenomenon of bad currency expelling good currency is widespread, and fake drug incidents continue to occur, which is caused by the drug administration system's inaction.

For companies that have passed the new GMP certification, what is needed is not the government's support and subsidies from the policy level, but strict regulatory measures and incentives. At the same time, for companies that have passed the new GMP certification, giving extra points in drug procurement is the greatest support. Only by re-establishing the people's confidence in Chinese food and medicine can the government's credibility continue.

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