中新网9月29日电 国家食品药品监督管理局今日在其官方网站发布了《2011年药品注册审批年度报告》。报告指出，2011年国家食药监局批准了中国自主研发的重组人戊型肝炎疫苗生产，这是全球首家获得批准的戊型肝炎疫苗，为戊型肝炎流行区高危人群提供了预防途径。

Beijing on September 29, the state food and drug administration today in its official website released[2011 annual report drug registration for examination and approval].The report says,The 2011 national food administration the Chinese independent research and development of recombinant human hepatitis a vaccine production,This is the first approved hepatitis a vaccine,For hepatitis popular area high-risk groups to provide the preventive ways.

　　报告指出，2011年，共批准药品注册申请718件。其中批准境内药品注册申请644件，批准进口74件。在644件境内药品注册申请中，化学药品569件，占88.4%；中药50件，占7.8%；生物制品25件，占3.8%。

The report says,In 2011,,A total of 718 pieces of drug approval application for registration.The territory of approval of the drug registration application 644 pieces,Approve the import 74 pieces.In 644 a domestic drug registration application,Chemical 569 pieces,Accounted for 88.4%;50 pieces of traditional Chinese medicine,7.8%;Biological products 25 things,3.8%.

　　报告提到，2011年，国家食药监局批准了中国自主研发的重组人戊型肝炎疫苗生产，这是全球首家获得批准的戊型肝炎疫苗，为戊型肝炎流行区高危人群提供了预防途径。

The report says that,In 2011,,National food administration the Chinese independent research and development of recombinant human hepatitis a vaccine production,This is the first approved hepatitis a vaccine,For hepatitis popular area high-risk groups to provide the preventive ways.

　　批准了中国自主研发的Sabin株脊髓灰质炎灭活疫苗进入Ⅲ期临床试验。该疫苗对于防止继发于口服脊髓灰质炎减毒活疫苗之后因突变、免疫缺陷等导致的脊髓灰质炎相关病例以及彻底消灭脊髓灰质炎疾病具有十分重要的意义。

Approved the Chinese independent research and development of the Sabin strain poliomyelitis inactivated vaccine into the Ⅲ phase of clinical test.The vaccine to prevent secondary to oral polio attenuated live vaccine for mutation after/Immune deficiency, etc in poliomyelitis related cases and eliminate polio disease has the extremely vital significance.

　　为有效应对手足口病对公共卫生健康的威胁，继2010年启动特殊审批程序批准国内3家企业申报的肠道病毒71型(EV71)灭活疫苗进入I期、II期临床试验后，2011年在国家食药监局制定的临床试验联合工作机制下，国家食药监局药品审评中心对临床试验具体实施给予了技术指导，保障了Ⅲ期临床试验的稳步、有序、顺利开展。

For effectively cope with hand, foot and mouth disease on public health threat,Since the 2010 start special approval of the examination and approval procedures domestic 3 enterprises to declare the intestinal virus type 71(EV71)Inactivated vaccine in stage I/Phase II clinical trial,In 2011, the administration's national food for clinical test joint work mechanism,The administration's national food drug evaluation center for clinical test specific implementation given technical guidance,Ensure the Ⅲ period clinical test steady/orderly/Smoothly carry out the.

　　此外，国家食药监局还批准了部分临床急需药品、治疗HIV感染的药品、治疗乙肝和疟疾、治疗骨质疏松的药品等15类重要治疗领域药品品种的生产。

In addition,National food's drug watchdog also approved the part of clinical need drugs/The drug treatment of HIV infection/Treatment of hepatitis b and malaria/Treat osteoporosis drugs and so on 15 kinds of important therapeutic areas drug varieties of production.

　　2011年，国家食药监局首次开展了进口药品境外生产现场检查。国家食药监局组织制定了进口药品境外生产现场检查工作程序和2011年进口药品境外现场检查试点工作方案。组成7个检查组，赴美国、法国、意大利、印度、匈牙利、韩国、日本等7个国家对贝伐珠单抗注射液、地诺前列素注射液、注射用盐酸吉西他滨等7个品种开展境外现场检查工作，实现了进口药品境外检查“零”的突破。

In 2011,,For the first time, the administration's national food in the imported drugs offshore production on-site inspection.National food administration organization has formulated the imported drugs offshore production site to check the work program in 2011 and the imported drugs overseas on-site inspection pilot work plan.Composition seven inspection team,Went to the United States/France/Italy/India/Hungary/South Korea/Seven countries such as Japan to bei cut bead MCAB injection/The forefront of the element's injection/Injection with hydrochloric acid gemcitabine 7 varieties for the on-site inspection work,Realize the imported drugs overseas examination"zero"breakthrough.