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    Home > Active Ingredient News > Drugs Articles > It takes a long time for imported drugs to enter the Chinese market as soon as possible

    It takes a long time for imported drugs to enter the Chinese market as soon as possible

    • Last Update: 2016-08-12
    • Source: Internet
    • Author: User
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    Source: economic reference daily August 12, 2016, cervical cancer was announced by who as the second most common cancer among women in developing countries, and one of the cancers with the highest mortality rate Ten years ago, cervical cancer vaccine began to be used in foreign countries, but it has not been able to enter the domestic market Young women can only go to Hong Kong, Macao and Taiwan, or even overseas for vaccination After a long wait, cervical cancer vaccine was approved to enter the Chinese market recently At the same time, the public opinion pays close attention to the long time consuming phenomenon of foreign drug import, and expects to shorten the approval time as much as possible while increasing the research and development of independent innovative drugs in China, so as to allow some domestic life-saving drugs in short supply to enter China earlier Cervical cancer vaccine is also called "HPV vaccine" As the first attempt to eliminate a cancer by vaccine, HPV vaccine has epoch-making significance The State Food and Drug Administration announced recently that it approved GSK's application for import registration of human papillomavirus absorption vaccine, a biological product for prevention, which is the first new vaccine to be applied for listing in China In China, cervical cancer has become the second highest incidence cancer in women aged 15 to 44, and there are about 13 new cases each year, with an incidence rate of about 10 million Globally, on average, one new case is detected every minute, and one woman dies of cervical cancer every two minutes Because it's so terrible, netizens praised cervical cancer vaccine's permission to enter the mainland market, but at the same time, public opinion began to pay attention to why it took 10 years for foreign drugs to enter the mainland Xia Peiyuan, director of the pharmacy department of Southwest Hospital Affiliated to the Third Military Medical University, said that in 2006, the world's first HPV vaccine was listed in the United States, and then more than 100 countries and regions carried out extensive vaccination Although the vaccine can not treat cervical cancer, it can prevent the infection of HPV, and has a preventive effect on 70% cervical cancer Therefore, domestic women have been looking forward to cervical cancer vaccine in the mainland to achieve vaccination The approval of the vaccine is stricter than that of the general drugs How to prove the protection of the new vaccine can only be achieved through the long-term tracking of the test population Li Ting, senior researcher of gotega medical investment group, said, "the mainland needs to queue up for approval of new drugs, which also slows down the process of listing HPV vaccine objectively." Xia Peiyuan believes that imported drugs or patented drugs have high gold content, good quality and huge market demand potential While increasing the research and development of independent innovative drugs in China, the examination and approval time can also be appropriately shortened Some netizens think that it's prudent for the country not to introduce some foreign drugs for so many years, which is responsible for the common people However, if it has been used clinically for a long time in other Asian countries and regions, the country should shorten the approval time, so that good drugs and life-saving drugs can enter the mainland earlier Zhou Qi, chairman of the gynecological oncology professional association of China Anti Cancer Association and director of the gynecological oncology department of Chongqing Cancer Hospital, said that Europe and the United States are the main "positions" of the original research drugs At present, many drugs used for tumor targeting and immunotherapy are not listed on the mainland After being put on the market in foreign countries, the clinical application of the original drugs in China is generally 5 to 8 years behind that in foreign countries Coupled with the intellectual property protection of the original research drug, the cost of buying a patent during the protection period will be very high She believes that China's efforts to increase the research and development of independent innovative drugs are the way to shorten the delay in the clinical use of good drugs Wang Shan, director of the oncology department of the children's Hospital Affiliated to Chongqing Medical University, also told reporters that taking anti gD2 antibody for children's solid tumors as an example, the United States has been using it for many years, but China has not approved it Domestic Pingyangmycin for solid tumors in children is not only cheap but also easy to use, but also can't be bought "It is a fact before us that good drugs from abroad cannot be imported and good drugs from China cannot be bought We hope it can be solved." She said Xia Peiyuan believes that the approval process of imported drugs that are really good and needed for treatment can be accelerated, but not be saved The reporter learned that there are nearly 4000 FDA drug review centers in the United States and more than 500 employees in the core agency of the European Union responsible for drug review At present, there are only more than 100 front-line reviewers in the national drug Audit Center, facing a large number of innovative drugs and generic drugs to be approved He hopes to have more professionals to enrich the front-line reviewer team Xia Peiyuan told reporters: "I have not heard that the state restricts the import of better foreign drugs In fact, many times the drug manufacturers do not understand the needs of the domestic audience, leading to some drugs not coming in." The supply of imported drugs and patent drugs should be guided by market demand, that is to say, through market research and market analysis, we should timely control market demand information and its dynamic changes, such as the varieties, quality and quantity of imported drugs required by the market.
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