The new version of the drug management standard promulgated drug wholesale companies face reshuffle

China Drying Network On February 19, the State Food and Drug Administration was informed that the newly revised “Pharmaceutical Business Quality Management Regulations” (hereinafter referred to as 'Pharmaceutical GSP') will be formally implemented on June 1, 2013.

Wang Lianglan, spokesperson of the State Food and Drug Administration, said that the amendments clarify the goal of “fully advancing one management tool, strengthening two key links, and breaking through three difficult issues”. One management tool is to implement the enterprise computer management information system. Two key links are the purchase and sale of medicines and the control of storage temperature and humidity. The three difficulties are bill management, cold chain management, and drug transportation. Compared with the current specifications, the newly revised pharmaceutical GSP has significantly improved the management quality of the company's business operations, and effectively strengthened the ability to control the quality of drug risks in circulation.

The newly revised Drug GSP has comprehensively improved the software and hardware standards and requirements of the company's operations. While ensuring the quality of drugs, it also increases the market access threshold, helps inhibit low-level repeated production, promotes industrial restructuring, and increases market concentration. . Li Guoqing, Director of the Department of Drug Safety Supervision of the State Food and Drug Administration said.

It is understood that there are 13,000 pharmaceutical wholesale companies and 420,000 pharmaceutical retail companies nationwide. This is a considerable number. In particular, there are too many wholesale companies and the scale is too small. This problem is very prominent. It can be said that it is a very important source of chaos or some irregular behavior in the production and circulation of pharmaceuticals. Everyone knows that there are too many problems in the business process, leading to some problems with the high prices of medicines, which are directly related to too many of our wholesale companies. As for the reduction in the number of our companies that can be achieved through the implementation of GSP, we do not set this as the goal of implementing the GSP. However, I think that if we can do a good job in implementing the GSP, we can make a significant reduction in the number of wholesale companies. Li Guoqing said.

The newly revised drug GSP has comprehensively improved the software and hardware standards and requirements of the company's operations. While ensuring the quality of drugs, it has also increased the market access threshold, helped to inhibit low-level repeated production, promoted industrial restructuring, and increased market concentration. degree.

In view of the amount of funds invested in the transformation of most enterprises' hardware and software, the total investment in the entire pharmaceutical and commerce industry is about 7 billion yuan. From the perspective of the current annual operating profit of 15.2 billion in the medical and pharmaceutical industry, it should be within the industrially affordable range. Li Guoqing said.

According to Li Guoqing, about 20% of wholesale companies and 15% of retail enterprises in 14 provinces and cities including Jiangsu, Liaoning, Guizhou and Yunnan have basically met the relevant conditions for the newly revised drug GSP certification during the process of amending the pharmaceutical GSP. 30% of wholesale companies and 20% of retail companies can pass their own efforts to pass certification.

According to calculations, the capital investment for GSP transformation in drug administration companies in different regions is different, but overall it will not exceed 1% of the total pharmaceutical sales in 2011. If the merger and reorganization of wholesale enterprises can be accelerated and the development of retail chain can be promoted, it can be eliminated. A few companies start or rebuild the logistics center's investment from scratch.

Although this kind of investment will bring certain cost pressures to pharmaceutical companies, especially SMEs with a single service content, in the context of increasingly fierce competition in the pharmaceutical market and the growing demand of the community for drug safety, the company must have personnel conditions. The level of facilities, facilities and equipment, as well as information management, can be upgraded to ensure market competitiveness and drug safety. Li Guoqing said.

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