问题 单项选择题 B型题

国家对新药审批时的检验属于()

A.抽查性检验

B.注册检验

C.国家检验

D.委托检验

E.进口检验

答案

参考答案:B

解析:

本组题考查药品质量监督检验的性质、类型。 药品质量监督检验包括: (1)抽查性检验:是由药品监督管理部门授权的药品检验机构,根据药品监督管理部门抽检计划,对药品生产、经营、使用单位抽出样品实施检验。发现质量问题和倾向,指导并加强国家对药品质量的宏观控制,督促企业、事业单位按药品标准生产、经营、使用合格药品。抽查检验属于药品监督管理部门的日常监督,抽查检验结果由政府药品监督管理部门发布药品质量检验公告,并依法处理不合格药品的生产、经营、使用者。 (2)注册检验:注册检验是指审批新药和仿制已有国家标准药品品种进行审批时的检验以及审批进口药品所需进行的检验。承担注册检验的药品检验机构应当在规定的时限内完成检验,出具药品注册检验报告,上报药品监督管理部门。 (3)国家检验:是指国家法律或药品监督部门规定某些药品在销售前必须经过指定的政府药品检验机构检验,合格的才准予销售。对于这种药品,虽然已经取得了药品生产批准证明文件,但是,如果在销售前没有经过药品检验机构对其药品实施检验,则该销售行为被认为是违法行为,所以此类型属于强制性检验。欧美许多国家的药事法中都有强制性检验的规定,我国于2001年开始实施,简称为“批检”。强制性检验,主要是对一些存在安全性隐患需要加强管理的品种实施上市前的检验行为。

单项选择题
阅读理解

阅读理解。

     The other day, my friend Jane was invited to a 40th birthday party. The time printed on the invitation was

7:30 pm. Jane went off with her husband, expecting a merry evening of wine, food, and song.

     By 9:45, everybody was having great fun, but no food had appeared. Jane and David were restless. Other

guests began whispering that they, too, were starving. But no one wanted to leave, just in case some food was

about to appear. By 11:00, there was still no food, and everyone was completely off their heads. Jane and

David left hungry and angry.

     Their experience suggests that the words on the printed invitations need to be made clearer. Everyone reads

and understands the invitations differently. Most of us would agree that 6:30-8:30 pm means drinks only, go

out to dinner afterwards; 8:00 pm or 8:30 pm means possible dinner, but 9:30 pm and any time thereafter means no food, eat beforehand, roll up late.

     But this is not always the case. If asked to a students' party at 6:30 pm, it is unaccepted for guests to appear on time. Being the first to arrive-looking eager-is social death. When my mother is asked to a party at 6:30, she

likes to be there, if not on time, then no later than seven. My age group (late thirties) falls somewhere between

the two, but because we still think we're young, we're probably closer to student-time than grown-up time.

     The accepted custom at present is confusing, sometimes annoying, and it often means you may go home

hungry, but it does lend every party that precious element of surprise.

1. The underlined words "off their heads" probably mean ______.

A. tired

B. crazy

C. happy

D. encouraging

2. Jane and David's story is used to show that ______.

A. party invitations can be confusing

B. party-goers usually get hungry at parties

C. people should ask for food at parties

D. birthday parties for middle-aged people are dull

3. For some young people, arriving on time for a students' party will probably be considered ______.

A. very difficult

B. particularly thoughtful

C. friendly and polite

D. socially unacceptable

4. What is the general idea of the text?

A. It's safe to arrive late just when food is served.

B. It's wise to eat something before going to a party.

C. It's important to follow social rules of party-going.

D. There's no need to read invitations carefully.