Another new regulation will be implemented, which will affect a large number of drugs and machinery manufacturers!

According to the medical website of May 7, another new regulation will be implemented, which will affect a large number of drugs and machinery dealers!

On May 3, the "National Technical Standards for Verification of the Validation Performance of Cold-chain Logistics for Pharmaceutical Products" (GB/T 34399-2017) was held in Beijing.

medical instruments In the field, especially the IVD industry, many products involve cold chain processing. The release of this national standard will undoubtedly greatly affect the distribution of medical devices. enterprise.

The standards stipulate the contents of temperature-controlled warehouses, temperature-controlled vehicles, refrigerators, incubators, and temperature monitoring systems that are involved in the cold chain logistics of pharmaceutical products. The contents of verification, requirements, and operating points, etc., are still relevant to the current pharmaceutical cold chain. There are certain difficulties and challenges. It is reported that this standard was formally implemented on May 1, 2018.

Everybody still remembers that two years ago, in the case of the Shandong illegal vaccine that shocked the whole country, a vaccine worth RMB 570 million was sold to 24 provinces across the country without stringent cold chain shipments. This sounded the alarm for the entire industry. Subsequently, medicine The industry began to pay more attention to cold chain logistics.

After the outbreak of the illegal vaccinations case in Shandong, the State Council revised the "Regulations on the Administration of Vaccine Circulation and Vaccinations," and clarified the strict management of vaccine circulation. It was necessary to establish a full traceability system for vaccines from production to use, strengthen storage, transport cold chain requirements, and add diseases. Control agencies, inoculation units are required to request temperature monitoring records in the receiving area.

From this point of view alone, the demand for pharmaceutical cold chain has greatly increased.

Recently, Ma Junsheng, the director of the State Post Bureau, stressed at the 5th Secretary's office meeting in 2018 that the express companies should be guided to accelerate the high-value-added services such as cold chain and pharmaceuticals.

It can be seen that with the intensification of innovative drug testing and medical device supervision in China, and the rapid development of the biopharmaceutical industry such as immunotherapy and genetic testing, the LTL cold-chain logistics and warehousing market with stringent temperature control and aging requirements has a promising future.

Some professionals stated that under the dual drive of policies and markets, the future of China’s cold chain transport drug The market size can reach 80 billion yuan.

In fact, many traditions medicine For enterprises, the cold chain still has different degrees of difficulty for them.

According to industry insiders' analysis, China's pharmaceutical cold chain logistics is characterized by high investment and high risk. The level of logistics infrastructure construction and informationization is low, and there is a lack of supervision in the transportation and distribution links.

According to analysis by industry insiders, compared with the cost of ordinary transportation, the cost of cold chain transportation is 80% higher, but the profit of cold chain logistics is only about 20%. Meanwhile, the construction cost of the pharmaceutical cold chain logistics in China, the electricity fee , Testing fees, etc. are at a relatively high level.

The technicians of Jiuzhou Tongtian Tianjin Pharmaceutical Company once told the media that the establishment of a cold chain warehouse requires at least 1 million yuan of capital investment, compared with 400 yuan/square meter for ordinary warehouses, and 3,000 yuan for cold storage equipped with thermal insulation systems. /Meters costs more than square meters. Also, in order to maintain the temperature uniformity of the warehouse, it takes high electricity charges, 10,000 square meters of cold storage needs at least 200,000 yuan / month of electricity. Plus the annual testing costs, that is, less than 150 square meters The warehouse inspection fee is 8,000 yuan, and the reefer verification fee is 1,200 yuan.

It can be seen that the cost of pharmaceutical cold chain logistics in China is high, and it is one of the major problems in the development of pharmaceutical cold chain.

In addition, cold chain logistics industry Talent Lack of information level is low, the thermostat can not achieve the continuity of data, accuracy is also an important factor in the development of pharmaceutical cold chain constraints.

In February 2016, the State Council issued the Decision on the Cancellation of the Second Batch of 152 Items of Administrative Approval of Centrally Specified Localities, and it is no longer necessary to engage in third-party pharmaceutical logistics business. This is considered to be the third-party logistics to enter the largest pharmaceutical logistics industry. Fortunately, among them, the most representative is SF.

As early as 2016, SF Express established the Cold Transportation Division to separate the pharmaceutical cold chain from the raw cold chain. It is reported that as of last May, the SF Cold Chain Pharmaceutical Land Transportation Network had already penetrated 21 cities, 22 Trunkline, 462 flows. In the next 3 years, SF Express will plan to create 6 to 7 core logistics centers for pharmaceutical supply chain, achieving warehousing capacity covering the whole country.

China Post is one of the earliest third-party logistics organizations in the field of pharmaceutical logistics distribution. As early as 2006, China Post began distributing drugs in pilot trials in Ningxia, and quickly obtained the GSP certification. In the following years, China Post again Successive trials were carried out in Gansu, Inner Mongolia and Anhui, and the distribution coverage of the grass-roots market continued to expand, and the county-township integrated distribution of basic medicines and non-base medicines was carried out. In addition, China Post also involved in pharmaceutical cold-chain transportation business.

Many people in the industry believe that with the strong entry of third-party logistics companies, especially SF Express, traditional pharmaceutical logistics companies will be under considerable pressure in the face of the already difficult pharmaceutical cold chain business. Traditional pharmaceutical logistics companies have The view is unexpected.

Prior to this, Yao Gongtong, general manager of the Kyushu Tongren Cold Chain Division, told the media that at present, the nation's pharmaceutical cold chain logistics service providers are based on traditional pharmaceutical logistics companies, so they are not worried about the intervention of Shunfeng at all. The media expressed the same view.

Regardless of changes in the market structure in the future, it is certain that with the continued growth in the market size of refrigerated drugs, competition within the industry will intensify, and the restructuring and integration of the pharmaceutical cold chain industry will also be imperative.