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    Home > Medical News > Medical World News > The first MAH special fund was released in Chongqing with a scale of 3 billion

    The first MAH special fund was released in Chongqing with a scale of 3 billion

    • Last Update: 2019-12-03
    • Source: Internet
    • Author: User
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    After the pilot 3 + 1 years, the market authorization holder (MAH) system, which is known as bringing a "timely rain" to innovative enterprises in China, was officially implemented nationwide on December 1 In the past four years, the industry and regulators have been hoping to break the ecological pattern of innovative drug R & D and production in China with MAH system Now, it is officially implemented in an all-round way What opportunities and challenges does MAH bring to the development of innovative drugs in China? In the face of the above problems, on December 2, "Yihong Seminar: MAH special topic and MAH special fund release ceremony" was held in Chongqing, and experts from all walks of life deeply analyzed the current situation At the same time, it was officially released at the meeting Drug marketing license holder (MAH) refers to the main body of drug research and development institutions, drug manufacturing enterprises and other entities that have drug technology, put products on the market in their name by applying for drug marketing license and obtaining approval documents for drug marketing license, and bear corresponding responsibilities for the whole life cycle of drugs (image source: Sina pharmaceutical) In China, pharmaceutical enterprises are mainly divided into the above three categories Before 2016, China's drug registration system was that if the R & D party wants to keep the drug approval number in its own hands, it needs to build a production line and obtain the production license Therefore, many new drug R & D teams are deterred by the threshold of "investing in the establishment of a factory", and only transfer the relevant drug technology to the manufacturer! According to Niu Zhengqian, executive vice president of China Pharmaceutical Enterprise Management Association, the implementation of MAH system has realized the separation of drug approval and enterprise, effectively solved the problem of "enduring pain and selling young crops", liberated the vast number of R & D institutions and R & D personnel, and brought infinite possibilities for the vast number of R & D institutions and R & D personnel The third chapter "drug marketing license holder" is specially set up in the new drug administration law, which makes comprehensive and systematic provisions on the conditions, rights, obligations and responsibilities of the holder It is clearly pointed out that MAH refers to "the enterprise or drug development institution that has obtained the drug registration certificate" In short, it is In the whole life cycle of a drug from birth to delisting, in addition to talents and R & D technology, it also needs production cooperation, follow-up promotion, fund incubation and other issues MAH needs to take responsibility for the whole life cycle of the drug, that is, for the drug This requires MAH to have, protect the safety of drugs, protect the safety of users and protect the rights and interests of users In order to ensure that MAH has the ability to implement the main responsibility, according to Professor Chen Zhen of Zhengzhou University, the holders of listing permission need to do a good job in the following aspects: 1 Establish the whole life cycle and chain, and provide professional personnel with corresponding qualifications and skills to ensure the normal operation of the quality system; 2 Establish the whole life cycle, and use risk management tools to carry out risk identification, analysis, evaluation and other work, to prevent or control all kinds of risks; 3 The holder of the listing license shall have certain; 4 Or by purchase, or by other means of guarantee, to guarantee the compensation ability in case of injury to the user due to the liability of the holder In addition, Professor Chen Zhen said that in order to become MAH, the first problem to be solved is how to effectively use and integrate market resources, make up for their own shortcomings, so as to effectively assume responsibility and fulfill their obligations As a holder of listing permission, it is necessary to integrate resources such as cro, cm0, cro and capital This conference officially released the first special fund of MAH in China, with a total amount of 3 billion yuan It will mainly invest in some high-quality clinical and production approval documents of drugs, and continuously incubate through various cooperation ways to achieve industrialization It is reported that the establishment of MAH special fund is mainly to comply with the drug listing permit holder system, in order to meet the development direction of Chongqing high tech Zone to support the biomedical industry The MAH special fund officially released at the launch ceremony is divided into three phases: , initiated and established by general partner Gao Rui Fund Management Co., Ltd., and entrusted CMB international as fund administrator and financial consultant , 。 Phase II and phase III are mainly initiated by Chongqing high tech Zone Development and investment group, China Merchants Bank, China Merchants Bank International and other social investment institutions Liu Huadong, assistant general manager of Chongqing high tech Zone Development and investment group, said that the investment direction of 3 billion capital has not been refined to varieties for the time being, but traditional polluting drugs or low-level chemical drugs are not considered, or they will pay attention to the added value of technology, and may focus on innovative drugs, high-end generic drugs and traditional Chinese medicine It should be noted that the investment scope of the first phase of MAH special fund is the pharmaceutical enterprises settled in Chongqing high tech Zone The MAH special fund and the drug listing license holder sign a gambling agreement The final goal is to form a pharmaceutical industry cluster in Chongqing high tech Zone and ensure the protection of state-owned assets Value added According to the introduction, three pharmaceutical enterprises, namely, Zhien pharmaceutical, South Korea benax and famousey, will be responsible for the early screening of investment targets and provide technical support for the promotion of the whole project.
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