Recently, the newly revised "Pharmaceutical Business Quality Management Standard" (new version of GSP) was introduced. The new version of GSP comprehensively enhances the hardware and software standards and requirements of the company's operations, improves the market's access threshold, helps to suppress low-level duplication, promotes industrial restructuring, and increases market concentration.

The concentration of pharmaceutical distribution industry will further increase, and the industry may usher in a period of shuffling.

Recently, the State Food and Drug Administration issued the newly revised "Policy Management Standards for Pharmaceuticals" (hereinafter referred to as the "new version of GSP"). Compared with the current specifications, the new version of the GSP has improved the requirements for the management of the company's operating quality, and has strengthened the ability to control the quality of drug risks in circulation. It is a major adjustment of China's circulation regulatory policy.

In this regard, the industry sources said that the introduction of the new version of the GSP has a landmark significance to improve the threshold of drug companies, large pharmaceutical wholesale enterprises will benefit, while nearly 80% of small wholesale pharmaceutical companies will face elimination, pharmaceutical distribution industry concentration The degree will increase dramatically.

12 years of grinding a sword

GSP is an abbreviation for English Good Supplying Practice. It is literally translated as “Good Drug Supply Specification” and is known as the pharmaceutical business quality management standard in China. It refers to a management system that guarantees that drugs meet the quality standards for the planning procurement, purchase acceptance, storage, sales, and after-sales service. Its core is to constrain the behavior of the company through a strict management system, to carry out quality control over the whole process of pharmaceutical operations, and to ensure the provision of quality drugs to users.

The reporter learned that China's current GSP was formally introduced in 2000 and it has been more than 12 years. The new version of the GSP has been revised since 2009 and will be released on February 19, 2013. It will be officially implemented from June 1, 2013. The new version of GSP comprehensively enhances the hardware and software standards and requirements of the company's operations, increases the market's access threshold, helps to curb low-level duplication, promotes industrial restructuring, and increases market concentration.

It is worth noting that the new version of the GSP draws on the regulatory policies of drug circulation from the World Health Organization, the developed countries and regions such as the United States and the European Union, and once again raises the management requirements of the company's operating quality, effectively enhancing the risk control of pharmaceutical circulation.

After the release of the new version of the GSP, it immediately triggered a strong response and became a hot topic in the community. Wen Zaixing, inspector of the Ministry of Commerce’s Market Order Department, said at a meeting of some key pharmaceutical wholesale companies organized by the China Pharmaceutical Business Association that the release of the new version of the GSP is a major event in the field of pharmaceutical circulation. The terms of the new version of the GSP have been increased from more than 70 in the current version to more than 170, which is not only conducive to the improvement of industry concentration, but also helps to implement the overall goals of the “12th Five-Year Plan” of the pharmaceutical industry.

Pharmaceutical companies also welcome the new GSP. Chen Guangyan, vice president of Guangzhou Pharmaceuticals, frankly stated in an interview with the International Business Daily: “From the current GSP to the launch of the new GSP, it took 12 years. In the past 12 years, the pharmaceutical circulation market and policies in China have undergone great changes. I can't find the standard, and I have been looking forward to the launch of the new GSP."

Large companies will benefit

At present, there are 13,000 drug wholesalers in the pharmaceutical circulation industry in China. Excessive wholesale enterprises have caused chaos in the drug wholesale market. Some pharmaceutical wholesale enterprises are actually engaged in business that is not a normal drug wholesale, distribution, etc., but rather an extension of the drug marketing of pharmaceutical companies, such as drug agents, clinical promotion, "slip ticketing" and so on.

Li Guoqing, director of the Department of Drug Safety Supervision of the State Food and Drug Administration, said earlier: “The number of existing pharmaceutical wholesale companies in China is too large. The implementation of the new version of the GSP has raised the barriers to entry, eliminated 10,000 companies, and left 3,000 or even 1,000 companies. Can meet the market demand, will not affect the availability of drugs."

Liu Xiaoping, deputy inspector of the Department of Drug Safety Supervision of the State Food and Drug Administration, also stated at the symposium that the introduction of the new version of the GSP will effectively combat the survivability of enterprises with unsafe quality, and chaos in areas such as scattered, minor, and chaotic drugs. Can effectively eliminate, large pharmaceutical companies take this opportunity to gain more market share, thereby reducing adverse vicious competition.

In this regard, Li Guangyi, vice president of Sinopharm Holding, said that in recent years, the gross margin of the pharmaceutical circulation industry has been reduced, and the profit margin is less than 1%. The new version of GSP has raised the industry's threshold and is conducive to the improvement of industry concentration. This is a large case for Sinopharm. For enterprises, it is undoubtedly a good news. According to him, at present, the company has been actively preparing to fully meet the challenges of the new GSP, and strive to take the lead through the new GSP certification. For the new version of the GSP in the cold chain supply, distribution and transportation and other requirements, the company is working hard to explore solutions, hoping to quickly implement the implementation details of the New Deal and support measures.

Wan Lingling, deputy general manager of East China Medicine, also shared the same feeling. She told the International Business Daily reporter that Huadong Medicine is very willing to take the lead in moving toward the requirements of the new version of the GSP, playing a leading role in the industry.

Wan Lingling suggested that as soon as possible, support policies should be issued to certified companies. For example, in the acquisition of small businesses by large companies, the government can provide support to large enterprises in various aspects, including accelerating the speed of acquisition approval, providing policy support, and offering drug bidding preferences.

In addition, the implementation of the new regulations will require multiple linkages. Wen Zaixing said that the next step should immediately release relevant departments to implement the new version of the GSP documents. In addition, the coordination of various departments is also very important.

Wen Xumin, chairman of the board of supervisors of Kyushu Thong Pharmaceutical Group, also stated that the new version of GSP has a three-year transitional period. To achieve its goals, it is necessary for the Ministry of Commerce, the Ministry of Health, the National Development and Reform Commission, the Ministry of Human Resources, and the Science and Technology Commission to form a joint force. The purpose, on the other hand, is to achieve the purpose of industrial restructuring.

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