问题 单项选择题 B1型题

()组织对新药研制情况及原始资料进行现场核查,对申报资料进行初步审查,提出审查意见。

A.省级药品监督管理局

B.国家食品药品监督管理总局

C.省级药品检验机构

D.国家药品检验机构

答案

参考答案:A

解析:本组题考查要点是"新药临床试验的有关部门"。《药品注册管理办法》第五十一条规定,省、自治区、直辖市药品监督管理部门应当对申报资料进行形式审查,符合要求的,出具药品注册申请受理通知书;不符合要求的,出具药品注册申请不予受理通知书,并说明理由。第五十二条规定,省、自治区、直辖市药品监督管理部门应当自受理申请之日起5日内组织对药物研制情况及原始资料进行现场核查,对申报资料进行初步审查,提出审查意见。申请注册的药品属于生物制品的,还需抽取3个生产批号的检验用样品,并向药品检验所发出注册检验通知。第五十三条规定,省、自治区、直辖市药品监督管理部门应当在规定的时限内将审查意见、核查报告以及申报资料送交国家食品药品监督管理总局药品审评中心,并通知申请人。

单项选择题
填空题

Part 1


·Read the article below and choose the best sentence from the list on the next page to fill each of the gaps.
·For each gap (1-8) mark one letter (A-H) on the Answer Sheet.
·Do not mark any letter twice.

Noise


Do you think there is too much noise in our city If you live near the airport, you’ll be unhappy only because a jet plane flying in the sky makes loud noise. The sound of planes or heavy vehicles is likely to cause deafness if heard continuously.
(1) They like to enjoy music when they are doing dull jobs. It is a new danger because "pop" music, when played through powerful amplifiers, can reach 120 decibels at a distance of 5 feet. (2) Recently it was discovered that many teenagers hear no better than people as old as 65. (3) For example, when newspapers and books are being printed, the noise level is about 85 decibels, and some of the workers will eventually become deaf. Scientists believe that 10 percent of all workers in Britain are being deafened by the noise in the factories.
(4) We all know that too much noise makes life difficult and unpleasant. (5) Workers in noisy offices are not as efficient as those in quiet offices. Noise makes people less efficient. (6)
In Britain the government has recently made several laws to reduce noise. (7) However, many people think that there are still not enough laws. For example, there are no laws to control noise by machines. In Japan, America and Norway there are such laws. (8)
Scientists in our country are trying their best to find out one way or another to keep down noise.
  • A. Moreover, noise of less than 85 decibels can make some people tired and anxious.
  • B. However, most people in our city do not seem to mind noise.
  • C. Moreover, the government has spent a good deal of money in making airports and main roads quieter.
  • D. It can damage health and prevent people from working well.
  • E. Can anything be done to reduce or control noise
  • F. It is known that a continuous noise of over 85 decibels can cause deafness.
  • G. We used to think that only those who work in very noisy places became deaf.
  • H. As a result, workers can claim compensation if they become dea