Heavy children's drug research success!
December 02, 2015 Source: Cypress Blue
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];The State Food and Drug Administration's CFDA issued the "Opinions on the Reform and Approval of Drug Medical Device Evaluation and Approval System" (Guo Fa [2015] No. 44) on August 9, 2015, promulgating the "Notice on Certain Policies for Drug Registration Review and Approval" (No. 230, 2015), for the drug registration and approval of the disease that has been criticized for decades, "one dose of antidote." Guofa No. 44 wants to cure "three kinds of diseases": First, the quality of application materials for drug registration is not high, and it needs to be supplemented and improved several times during the review process, which seriously affects the efficiency of review and approval; second, repeated construction of generic drugs, repeated applications There is a big gap between the quality of some generic drugs and the international advanced level. Thirdly, the clinical approval of new drugs is too long, and drug research and development institutions and researchers cannot apply for drug registration, which affects the enthusiasm of drug innovation; The “Three-flavor prescription†issued by CFDA No. 230: First, the application for clinical trial of new drugs is subject to one-time approval, and no more means of instalment declaration or instalment review and approval; secondly, generic drugs and original research The principle of consistent drug quality and efficacy is accepted and reviewed and approved. The generic bioequivalence test was changed from the approval system to the filing system. The history of the Chinese-style generic drug that declares the cottage version is coming to an end; the third is to open a green channel for clinically urgent drug approval. Children and elderly need special medicines.
The use of medicines for special populations (children and elderly) has long been highly valued by the medical and medical management departments. The efficiency and safety of children's medications are affecting the hearts of hundreds of millions of parents. According to data from the Center for Adverse Drug Reaction Monitoring of the Ministry of Health in 2012, hundreds of people die every day from adverse drug reactions in China, of which 32% are children. On December 1, 2012, CCTV’s focus interview column broadcasted a report titled “Following Child safety: What about children? The program provides detailed investigation and interviews on the status quo of children's medication in China; the data provided by the National Federation of Industry and Commerce Pharmaceutical Industry Association shows that there are currently more than 3,500 preparations in China, only 60 for children, accounting for only 1.7%; In addition to the scarcity of varieties, the problems of inappropriate dosage and dosage forms for Chinese children and incomplete information on adverse reactions have become more prominent. For this reason, in May 2014, six ministries and commissions such as the National Health and Family Planning Commission issued a special issue on the protection of children's drugs. (National Pharmacy Administration [2014] No. 29); Wu Hao, deputy director of the State Food and Drug Administration and deputy director of the State Health Planning Commission, publicly stated on the drug approval and drug safety issues: the ills of slow drug approval within three years, And to formulate special approval policies for children's medicines; at the same time, it is also required to speed up the implementation of the evaluation of the quality of generic drugs, so that the people can really eat reliable drugs. It is precisely because of the wise and daring leadership of Director Wu Hao, the green channel for the approval of children's medications and the evaluation of the quality consistency of generic drugs have been on the ground for more than a year. The old ice has been broken, and the cure for the stubborn disease is broken. Come to the surface!
By Guowei Yaozheng [2014] No. 29 Dongfeng, August 2014, Aojina Pharmaceutical held the first generic drug and children's drug summit forum in Shanghai. The forum invited Professor Sun Huajun from Shanghai Children's Hospital and Professor Shao Jie, director of the pediatrics department of Ruijin Hospital, to conduct dozens of famous national experts to conduct oral drug formulation research for children, and comprehensively and deeply analyze the current situation of children's medication in China. After the meeting, relying on the Internet social platform, it launched an initiative to millions of parents and 10,000 pediatrician pharmacists across the country to participate in the research and development of children's drugs, and solicited opinions on the dosage, dosage form, taste, packaging and logistics of children's medicines. "A new open all-round research and development model.
In March 2015, the National Health and Family Planning Commission reissued (Weizhi Yaozheng [2015] No. 150) notice, the establishment of the National Health and Family Planning Commission for Children's Medicine 59 expert committee, aimed at summarizing pediatric clinical medication experience and safe medication data, forming Industry consensus to promote the establishment of a scientific and standardized guide to children's medication. At the first time, Ogina Pharmaceutical sent a letter to the 59-member group, and at the same time sent a letter to the experts and college students engaged in clinical research of children's medicine all over the country, and collected a number of reasonable suggestions for the design concept of Ogina's children's medicine.
After nearly 500 R&D trials and numerous scientific demonstrations, the research on the children's antipyretic and analgesic effervescent tablets of Ogina Pharmaceuticals has finally been successful. On November 26, 2015, the application for registration was officially submitted, becoming a pre-emptive child. The first person to approve the doorbell of the drug green.
Dr. Wei Guoping, Chairman of Ogina, said that choosing the “Bell Bell†for Thanksgiving is of great significance. As a private technology enterprise, we must first be grateful to the various users, patients, and medical experts of Ogina for 24 years. At the same time, we are grateful to the friends from all walks of life for their strong support to Ogina, and we are more grateful to the government departments at all levels for their support for private technology companies. Aojina can only repay the society with better products, more environmentally friendly production methods and more perfect services, and return this great Chinese dream era!
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