2023-06-27 08:26:55
[Jinyang.com]New regulations will be implemented from July 1: Guangdong supports the integrated operation of drug wholesale and retail to reduce costs and increase efficiency to promote high-quality development of the industry
Conference site map
Text/Photo by Chen Zeyun
Starting from July 1, the “Several Provisions on the Storage and Transportation Management of Pharmaceutical Wholesale Enterprises of Guangdong Provincial Drug Administration” (hereinfollowing referred to as the “Several Regulations”) will be officially implemented, focusing on solving the blockages in the process of licensing and acceptance of pharmaceutical wholesale enterprises and entrusted storage and transportation of pharmaceuticals To solve some difficult problems, build a mechanism for acceptance and integrated supervision of new start-up licenses for pharmaceutical wholesale enterprises in Guangdong Province. On June 26, the Guangdong Provincial Drug Administration held a press conference to interpret the “Several Regulations”.
According to the new regulations, Guangdong encourages the innovation of new modes of drug operation, supports drug wholesale and retail chain enterprises to implement integrated wholesale and retail operations, and the same business entity can apply for drug wholesale and retail chain operation licenses in accordance with the law. It is reported that the new regulations are applicable to drug wholesale enterprises newly established in the province and newly entrusted with storage and transportation business, which is conducive to further optimizing resource allocation, stimulating the vitality of the drug distribution market, building a modern drug distribution system, and promoting the high-quality development of Guangdong’s drug distribution industry. public drug safety.
innovation model
Promoting operating companies to reduce costs and increase efficiency
The “Several Provisions” insist on innovating the new model of drug operation, and support drug wholesale and retail chain enterprises to implement integrated wholesale and retail operations. The same business entity can apply for drug wholesale and retail chain operation licenses in accordance with the law.
Wholesale-retail integrated operation is an important measure for Guangdong to innovate the pharmaceutical business model. Enterprises that carry out wholesale-retail integrated business should meet the standards for the establishment of pharmaceutical wholesale enterprises, the requirements of this regulation, and the acceptance criteria for drug retail chain enterprises. The license for pharmaceutical wholesale and retail chain operation will be handled for the same business entity in accordance with the law.
According to Tian Shougang, Director of the Second Division of Drug Supervision of the Provincial Drug Administration, the integrated operation of wholesale and retail can effectively integrate the internal wholesale and retail chain resources of the enterprise, and share conditional resources such as warehousing, facilities and equipment, personnel and information management systems. The integrated and coordinated operation of various resources such as merchants and logistics realizes the integration of wholesale and retail, reduces costs and increases efficiency, and promotes the improvement of overall efficiency.
In order to further deepen the “decentralization, management and service” and optimize the business environment, the “Several Regulations” also support group companies to integrate internal drug storage and transportation resources, and adopt a multi-warehouse collaborative model to carry out drug storage and transportation business within the enterprise to further revitalize resources. In addition, the new regulations also fully consider the development needs of the cold chain storage and transportation segment market. For enterprises that specialize in the cold chain drug business, separate and clear requirements are made in terms of storage facilities, transportation vehicles, and warehouse configuration. Quality and safety are also conducive to the standardized development of a new model of exclusive cold chain pharmaceutical logistics.
“We will increase the publicity and interpretation of relevant policies, so that good policies can benefit more companies, and policies that benefit enterprises can be implemented in a standardized and orderly manner, so as to fully stimulate the vitality of the drug distribution market.” Tian Shougang pointed out.
Protect remote areas
The “last mile” of drug delivery
The “Several Provisions” adhere to a prudent and inclusive regulatory approach, encourage enterprises to optimize the layout of urban and rural drug storage and transportation, and under the premise of ensuring quality and safety, set the conditions for setting up enterprises in remote areas to be appropriately reduced, and guide drug storage, transportation and distribution resources to be appropriately tilted to remote areas , to meet the “last mile” distribution needs in remote areas, and to achieve effective and balanced coverage of drug storage and transportation in urban and rural areas of the province.
Huang You, a second-level investigator of the Drug Supervision Division II of the Provincial Drug Administration, introduced that “slow drug distribution in rural areas” has been a real problem for a long time. Compared with cities, rural areas have a lower population density and higher operating costs for enterprises, resulting in overall drug distribution. The network is not perfect.
Therefore, in the “Several Regulations” this time, the Provincial Bureau supports and encourages legal and compliant wholesale companies to extend their distribution to rural towns from the policy perspective: First, allow group companies to carry out “multi-warehouse collaboration” to achieve the optimal delivery of drugs The second is to standardize and simplify the conditions of logistics distribution transfer and distribution places, improve the terminal distribution outlets, and ensure the “last mile” distribution; the third is to ensure the quality of wholesale products with registered addresses and warehouse addresses in remote areas. Enterprises have made appropriate adjustments to the requirements of hardware conditions such as storage facilities and equipment to reduce the cost of enterprise operations.
“Our ultimate goal is to effectively expand the coverage of rural grassroots drug distribution through these measures and make up for the shortcomings of drug access.” Huang You said.
dynamic trace
Consolidate the bottom line of drug quality and safety
According to reports, the “Several Regulations” will not break the existing market structure, will not affect the reasonable interests of existing enterprises, will maintain the basic stability and order of the market, strongly encourage existing enterprises to gradually realize the requirements of these regulations, and promote existing enterprises to steadily improve their storage and transportation levels , to systematically promote the high-quality development of the pharmaceutical distribution industry.
The “Several Provisions” insist on strengthening the bottom line of drug quality and safety, and promote the integration of licensing and supervision of drug wholesale enterprises. Among them, in order to consolidate the entrusting party’s main responsibility and management responsibility, and effectively ensure that the entire process of drug storage and transportation continues to be legal and compliant, the “Several Provisions” highlight that the entrusting party is fully responsible for the quality of entrusted storage and transportation of drugs, and guide the entrusting party to give priority to choosing higher quality drugs. Entrusted parties with high quality management level and strong operational capabilities carry out entrusted business, and clearly require that the entrusted party’s information management system should realize effective connection and interconnection with the entrusted party’s drug information.
At the same time, the entrusting party’s drug traceability information management system is required to be connected with the electronic drug circulation supervision system of Guangdong Province to ensure that the supervision department can achieve full traceability and dynamic supervision.
policy mix
Promote high-quality development of the industry
Yan Zhen, a member of the party group and deputy director of the Provincial Drug Administration, pointed out that in recent years, Guangdong has issued a series of policy documents to promote the high-quality development of supervision and industry, including “Guangdong Province Accelerates the Improvement of the Modern Drug Distribution System and Promotes the High-quality Development of the Drug Distribution Industry” The “Guangdong Provincial Drug Retail License Inspection and Acceptance Implementation Rules”, “Guangdong Provincial Drug Retail Chain Operation Supervision and Management Measures”, etc., the “Several Regulations” and the above-mentioned normative documents have jointly formed the systematic supervision of the pharmaceutical circulation field in Guangdong Province policies, coordinate safety and development, escort drug safety at a high level, and promote high-quality industrial development with new measures.
With the support and escort of policies, in 2022, the total drug circulation in Guangdong Province will reach 281 billion yuan, an increase of 7.3% once morest the trend, ranking first in the country; the total number of pharmacies in the province has increased from 56,363 to the current 64,716, and the chain rate has increased from 37 % has increased to 48%, and the management of pharmacies has become more standardized and orderly; the number of enterprises operating the first-run electronic data sharing service platform is close to 2,000, and the electronic online sharing and exchange of first-run data has become a reality, which is conducive to improving the drug traceability system and laying a foundation for the future The nationwide practice path of Guangdong is provided; more than 3,000 Class B non-prescription pharmacies have been opened and operated across borders, which greatly facilitates the daily urgent need of medicines for people in the community, especially those in remote areas at night.
The Provincial Food and Drug Administration stated that it hopes that the promulgation of the “Several Regulations” will further strengthen the bottom line of drug operation quality and safety, systematically solve the policy blockages of new start-up and entrusted storage and distribution business of Guangdong drug wholesale enterprises, and take innovative measures The effect of promoting high-quality development of the industry and other aspects.
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