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    Home > Active Ingredient News > Drugs Articles > The food and Drug Administration once again made it clear that the online drug management and supervision should follow the principle of "online and offline consistency"

    The food and Drug Administration once again made it clear that the online drug management and supervision should follow the principle of "online and offline consistency"

    • Last Update: 2017-10-09
    • Source: Internet
    • Author: User
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    Source: with the rapid development of China's e-commerce on October 9, 2017, "online shopping" has become one of the main ways of daily consumption of Chinese residents, and access to drugs through the Internet is more widely accepted by the public because of its convenience and rapidity

    Recently, the State Council printed and distributed the decision on canceling a number of administrative licensing matters, and decided to cancel the examination and approval of Internet drug trading service enterprises (third parties)

    Once the news was released, it attracted wide attention and strong repercussions in the society

    However, the "opening up" of online drug business approval does not mean the lowering of regulatory threshold

    "The food and drug regulatory authorities shall carry out supervision in accordance with the principle of" consistency online and offline "

    The network drug seller shall have the qualification of drug production and operation, and strictly abide by the "drug operation quality management specification"

    The food and drug regulatory authorities will continue to strengthen in-process and post event supervision

    " The relevant person in charge of the Department of pharmaceutical supervision of the State Food and drug administration made an explanation

    Network drug trade refers to the behavior of engaging in drug trade-related activities through the network (including mobile Internet and other networks)

    According to incomplete statistics of the Ministry of Commerce, in 2015, the total sales volume of China's pharmaceutical e-commerce reached 47.6 billion yuan (including medical devices); in 2016, it rapidly climbed to 61.2 billion yuan

    Today, with the strong development of Internet medicine economy, it is urgent and necessary to further standardize the online medicine business and formulate targeted and operational regulatory measures

    "The State Food and drug administration has started to formulate measures for the supervision and administration of online drug distribution." The head of the Department said

    In order to make all sectors of the society correctly understand the requirements of online drug management and supervision, the relevant person in charge of the Department of pharmaceutical and chemical supervision makes the following further explanations for the scope of online drug business subjects, principles of practice, conditions for engaging in online drug sales activities, relevant obligations, supervision and management, etc

    The network drug sellers who must obtain the qualification of drug production and operation shall be the chain enterprises of drug production, wholesale and retail with the qualification of drug production and operation, and there shall be physical stores under the network of drug sales

    Other enterprises, institutions and individuals shall not engage in online drug sales

    The network drug trade shall comply with the "drug trade quality management standards"

    The food and drug administration shall conduct supervision and management in accordance with the principle of "consistency on and off the Internet"

    The online sale of drugs by retail enterprises is limited to the online sale of over-the-counter drugs, and shall not exceed the scope of the drug business license of the enterprise

    If the online drug seller is a drug production or wholesale enterprise, it shall not sell drugs to individual consumers

    If the online drug seller is a drug retail chain enterprise, it is not allowed to sell prescription drugs or drugs with special management requirements of the state through the Internet

    Enterprises should strengthen the awareness of medical laws and regulations In addition to meeting the requirements of laws, regulations and rules of national drug supervision and online transaction management, online drug sellers should also have application software and relevant databases that meet the actual needs of enterprise management, which can ensure the requirements of business development; establish the safety management system of online drug sales, realize the traceability and verification of the whole process of drug sales; establish and guarantee the quality and safety of drugs In addition, if the sales target is individual consumers, an online pharmaceutical service system should be established with licensed pharmacists to guide the rational use of drugs

    The food and drug regulatory authorities shall, in accordance with the provisions of laws, regulations and rules, carry out supervision and inspection on online drug trading in accordance with their authorities

    It is proposed to establish a national unified network drug trade information monitoring system to monitor the network drug trade information, and to deal with the information suspected of violating laws and regulations in different levels

    We will strengthen cooperation with relevant departments and improve the effectiveness of coordinated law enforcement.
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