On February 2nd, 65438 "Hony seminar: MAH special topic and release ceremony of MAH special fund" was held in Chongqing-the total amount of MAH special fund reached 3 billion, which will mainly invest in some high-quality drug clinical approval documents and drug production approval documents, and continue to incubate in various ways of cooperation, and finally realize industrialization. It is reported that the establishment of MAH special fund is mainly in line with the system of drug listing license holders and the development direction of Chongqing High-tech Zone supporting biomedical industry. Liu Huadong, assistant general manager of Chongqing High-tech Zone Development and Investment Group and chairman of Chongqing Gaoyi Investment Development Co., Ltd., revealed at the press conference that the total size of MAH special fund is 3 billion yuan, which is divided into three phases, the first phase is 500 million yuan, the second phase is 654.38+0 billion yuan, and the third phase is 654.38+0.5 billion yuan. The investment direction of the fund will focus on the added value of technology. Liu Huadong, assistant general manager of Chongqing High-tech Zone Development and Investment Group, is worth noting that the main investment areas of the fund are recombinant protein drugs, biological vaccines, cell therapy drugs, antibody drugs, biological blood products and high-end generic drugs. And the investment target of the first phase fund will be locked in Chongqing High-tech Zone or the project that will be settled in Chongqing High-tech Zone after investment. According to reports, Zhien Pharmaceutical, South Korea Binex and Famesai will be responsible for the pre-screening of investment targets and provide technical support for the promotion of the whole project. 65438+February 1, the new version of the Drug Administration Law was officially implemented, and the new version of the Drug Administration Law devoted a chapter to making relevant provisions for drug marketing license holders. Niu Ganzheng, executive vice president of China Pharmaceutical Enterprise Management Association, said at the launching ceremony that the implementation of MAH system has separated drug approval from enterprises, liberated R&D institutions and R&D personnel, and the flexibility of the market will bring infinite possibilities to R&D institutions and R&D personnel. On the same day, Niu, executive vice president of China Pharmaceutical Enterprise Management Association, Hongyi Business School of Shenyang Pharmaceutical University, the organizer of the release ceremony, also released the 2020 course catalogue. According to the on-site introduction, Hony Business School will carry out relevant courses in Chongqing to provide talents and technical support for the effective use of the fund. The marketing license holder system encourages drug innovation. The drug marketing license holder (MAH) refers to the drug research and development institutions, drug production enterprises and other entities with drug technology. By applying for the drug marketing license, we obtain the approval of the drug marketing license, put the product on the market in its name, and bear corresponding responsibilities for the whole life cycle of the drug. Exploring the listing license holder system in the State Administration of Pharmaceutical Products to realize the separation of products from enterprises is conducive to strengthening drug life cycle management, encouraging drug innovation, reducing low-level redundant construction and optimizing resource allocation. It is worth noting that although the drug marketing license holder system has realized the separation of products and enterprises, it has got rid of the asset-oriented model of drug research and development. However, the whole life cycle of a drug from birth to delisting requires not only talents and R&D technology, but also the cooperation of production, subsequent promotion, incubation of funds, as well as the relevant requirements of the new Drug Administration Law, which puts higher demands on drug marketing license holders. The holder of the listing permit at the venue is responsible for the whole life cycle of the drug. According to the Drug Administration Law, the marketing license holder is responsible for non-clinical research, clinical trials, production and marketing, post-marketing research, adverse reaction monitoring, reporting and handling of drugs. The legal representative and principal responsible person of the drug marketing license holder shall be fully responsible for the drug quality. Dr. Kyle, a professor at Zhengzhou University School of Pharmacy, pointed out that drug marketing license holders need to have the ability of life-cycle management of drugs in order to effectively assume the responsibilities stipulated by law. Drug marketing license holders need to have the ability of quality management, risk prevention and control, liability compensation and so on. Ensure the safety, effectiveness and quality controllability of drugs, protect the safety of users and safeguard the rights and interests of users. Professor Marco, School of Pharmacy, Zhengzhou University, specifically, the marketing license holder needs to establish a quality management system with full life cycle and full chain, and be equipped with professionals with corresponding qualifications and skills to ensure the normal operation of the quality system; Listing permit holders need to establish a life-cycle risk prevention and control system, use risk management tools to carry out risk identification, analysis, evaluation and other work to prevent or control various risks; The holder of the listing license shall have a certain economic ability, or ensure the compensation ability of the user when he is damaged due to the holder's responsibility by purchasing insurance or other means of protection. Marco, the holder of the listing license, needs to integrate resources. The first problem that MAH needs to solve is how to effectively use and integrate market resources to make up for its shortcomings. As a listing license holder, it is necessary to integrate and utilize the services and financial resources provided by CRO, CMO and CSO according to their own capacity building. A guest at the scene also pointed out that enterprises should not always think about making up shortcomings, but should carry forward the long board and add value in interaction. In this process, capital also plays a very important role. It is worth noting that although various contract outsourcing organizations can provide various professional services, MAH also needs to have corresponding professional capabilities, which may include R&D management, registration management, production management, circulation management, pharmacovigilance and change management. Finally, Kyle concluded that MAH can entrust drug R&D, production and sales, but it needs to have enough ability to effectively supervise all the entrusting parties, truly realize strong alliance and complementary advantages, and give full play to the role of MAH system in resource integration. Disclaimer: The above content comes from the Internet, and the copyright belongs to the original author. If there is any infringement of your original copyright, please let us know and we will delete the relevant content as soon as possible.