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The author:(作者)左published in(发表于) 2013/11/13 7:10:12 By 2015 all marketed drugs will be electronic monitoring
Beijing authorities wide nets, November 12 (reporter Shen Jingwen) according to voice of the national news coverage, the third session of the General Assembly opened today in China's biotechnology industry, Central Government, transnational and local drug firms to jointly explore management and development of biopharmaceutical market. State food and drug regulatory agency said, before the year 2015 electronic monitoring for all minimum package of marketed drugs.
Currently, biotech drugs have been widely used to treat cancer, AIDS and other major diseases and rare diseases, such as cystic fibrosis. Despite China's first H1N1 influenza vaccine and biological agents such as hepatitis e vaccine, but at the scale of China's year of USD 70 billion pharmaceutical market, biological and bio-similar drugs only for the share of 10%. United States Ambassador to China, Locke believed that the approval process is too long, to a certain extent affected the rapid development of the Chinese pharmaceutical market.
Gary Locke: according to an industry report, a new drug is approved in China, slower than the average international market for 5 years. Applications for clinical trials of drugs in China 19-22 months to be granted an average, far slower than Korea or Hong Kong SAR, China. These factors seriously affect the scope of transnational corporations to China on its new drug trials.
China's drug supervision "severity" of being, the State food and drug administration of party members said bian zhenjia, this trend will continue.
Bian zhenjia: by 2015 for all full implementation of electronic monitoring of marketed drugs, achieving a minimum flow of packaging can be carried out on all medicine tracked medicines quality traceability of the whole process. In all drug manufacturers introduced a new version of pharmaceutical GMP (pharmaceutical production quality management standard), by the end of 2013 forcing blood products, vaccines, sterile pharmaceutical products meet the new GMP requirements, force other all drugs produced by the end of 2015 all new version of the drug GMP requirements.
(Original title: all marketed drugs by 2015 China will fully implement the electronic supervision)
央广网北京11月12日消息(记者沈静文)据中国之声《全国新闻联播》报道，第三届中国生物产业大会今天开幕，中美政府、跨国和本土药企共同探讨生物制药市场的管理与发展。国家食药监管总局表示，将在2015年前对所有上市药品的最小包装实行电子监管。
目前，生物技术药物已广泛用于治疗癌症、艾滋病等重大疾病和囊性纤维变性等罕见病。尽管中国率先研制H1N1流感疫苗和戊型肝炎疫苗等生物制剂，但在我国年规模700亿美元的医药市场，生物制剂和生物类似药的比重仅为10%。美国驻华大使骆家辉认为，审批流程过长，在一定程度上影响了中国生物制药市场的迅速发展。
骆家辉：根据一份产业报告，一种新药在中国获得批准的时间，要比国际市场平均慢5年。药品的临床试验申请在中国平均要19-22个月才能获批，远远慢于韩国，甚至是中国香港地区。这些因素会严重影响跨国公司将中国列入自己的新药试验范围。
我国药品监管“严”字当头，国家食药监管总局党组成员边振甲表示，这一态势还将持续。
边振甲：力争到2015年对所有上市药品全面实施电子监管，实现对所有药品的最小包装可进行流向追踪，实现药品全过程质量追溯。在所有药品生产企业中推行新版的药品GMP(药品生产质量管理规范)，2013年底前强制要求血液制品、疫苗、无菌药品达到新版GMP要求，2015年底前强制其他所有药物类别生产全部达到新版药品GMP的要求。
(原标题：2015年前我国将对所有上市药品全面实施电子监管)
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