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关于印发《药品研究实验记录暂行规定》的通知

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关于印发《药品研究实验记录暂行规定》的通知

国家食品药品监督管理局


关于印发《药品研究实验记录暂行规定》的通知


国药管安[2000]1号
各省、自治区、直辖市药品监督管理局或卫生厅(局)、医药管理部门:  为加强药品研究监督工作,保证药品研究质量,国家药品监督管理局组织制定了《药品研究实验记录暂行规定》(以下简称《规定》),现印发给你们,并就有关工作通知如下:  一、药品研究实验记录是药品研究机构撰写药品申报资料的依据。真实、规范、完整的实验记录是保证药品研究结果真实可靠的基础。《规定》的发布与实施,有利于药品研究机构规范药品研究实验记录,保证药品研究质量。各级药品监督管理部门和各药品研究机构应予以足够的重视。  二、各省、自治区、直辖市药品监督管理部门要根据本《规定》的要求,加强对本辖区药品研究机构规范实验记录工作的指导和监督检查,对本《规定》的实施情况和实施中的问题及时报告国家药品监督管理局。  三、《规定》对药品研究中实验记录提出了基本要求。各药品研究机构可根据本机构所从事药品研究领域的特点,遵照《规定》中的原则,制定适合本机构研究特点的具体办法。   特此通知    国家药品监督管理局   二000年一月三日    药品研究实验记录暂行规定   第一条 为加强对药品研究的监督管理,保证药品研究实验记录真实、规范、完整,提高药品研究的质量,根据《中华人民共和国药品管理法》、《国家档案法》以及药品申报和审批中的有关要求,制定本规定。  第二条 凡在我国为申请药品临床研究或生产上市而从事药品研究的机构,均应遵循本规定。  第三条 药品研究实验记录是指在药品研究过程中,应用实验、观察、调查或资料分析等方法,根据实际情况直接记录或统计形成的各种数据、文字、图表、声像等原始资料。  第四条 实验记录的基本要求:真实、及时、准确、完整,防止漏记和随意涂改。不得伪造、编造数据。  第五条 实验记录的内容通常应包括实验名称、实验目的、实验设计或方案、实验时间、实验材料、实验方法、实验过程、观察指标、实验结果和结果分析等内容。  (一)实验名称:每项实验开始前应首先注明课题名称和实验名称,需保密的课题可用代号。  (二)实验设计或方案:实验设计或方案是实验研究的实施依据。各项实验记录的首页应有一份详细的实验设计或方案,并由设计者和(或)审批者签名。  (三)实验时间:每次实验须按年月日顺序记录实验日期和时间。  (四)实验材料:受试样品和对照品的来源、批号及效期;实验动物的种属、品系、微生物控制级别、来源及合格证编号;实验用菌种(含工程菌)、瘤株、传代细胞系及其来源;其它实验材料的来源和编号或批号;实验仪器设备名称、型号;主要试剂的名称、生产厂家、规格、批号及效期;自制试剂的配制方法、配制时间和保存条件等。实验材料如有变化,应在相应的实验记录中加以说明。  (五)实验环境:根据实验的具体要求,对环境条件敏感的实验,应记录当天的天气情况和实验的微小气候(如光照、通风、洁净度、温度及湿度等)。  (六)实验方法:常规实验方法应在首次实验记录时注明方法来源,并简述主要步骤。改进、创新的实验方法应详细记录实验步骤和操作细节。  (七)实验过程:应详细记录研究过程中的操作,观察到的现象,异常现象的处理及其产生原因,影响因素的分析等。  (八)实验结果:准确记录计量观察指标的实验数据和定性观察指标的实验变化。  (九)结果分析:每次(项)实验结果应做必要的数据处理和分析,并有明确的文字小结。  (十)实验人员:应记录所有参加实验研究的人员。  第六条 实验记录用纸  (一)实验记录必须使用本研究机构统一专用的带有页码编号的实验记录本或科技档案专用纸。记录用纸(包括临床研究用病历报告表)的幅面,由研究单位根据需要设定。  (二)计算机、自动记录仪器打印的图表和数据资料,临床研究中的检验报告书、体检表、知情同意书等应按顺序粘贴在记录本或记录纸或病历报告表的相应位置上,并在相应处注明实验日期和时间;不宜粘贴的,可另行整理装订成册并加以编号,同时在记录本相应处注明,以便查对。  (三)实验记录本或记录纸应保持完整,不得缺页或挖补;如有缺、漏页,应详细说明原因。  第七条 实验记录的书写  (一)实验记录本(纸)竖用横写,不得使用铅笔。实验记录应用字规范,字迹工整。  (二)常用的外文缩写(包括实验试剂的外文缩写)应符合规范。首次出现时必须用中文加以注释。实验记录中属译文的应注明其外文名称。  (三)实验记录应使用规范的专业术语,计量单位应采用国际标准计量单位,有效数字的取舍应符合实验要求。  第八条 实验记录不得随意删除、修改或增减数据。如必须修改,须在修改处划一斜线,不可完全涂黑,保证修改前记录能够辨认,并应由修改人签字,注明修改时间及原因。  第九条 实验图片、照片应粘贴在实验记录的相应位置上,底片装在统一制作的底片袋内,编号后另行保存。用热敏纸打印的实验记录,须保留其复印件。  第十条 实验记录应妥善保存,避免水浸、墨污、卷边,保持整洁、完好、无破损、不丢失。  第十一条 实验记录的签署、检查和存档  (一)每次实验结束后,应由实验负责人和记录人在记录后签名。  (二)课题负责人或上一级研究人员要定期检查实验记录,并签署检查意见。  (三)每项研究工作结束后,应按归档要求将药品研究实验记录整理归档。  第十二条 本规定由国家药品监督管理局负责解释。  第十三条 本规定自发布之日起实施。

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劳动人事部、卫生部关于乡村医生工龄计算问题的复函

劳动人事部 卫生部


劳动人事部、卫生部关于乡村医生工龄计算问题的复函
劳动人事部、卫生部



湖北省改革工资制度领导小组办公室:所询劳人薪〔1985〕41号文附件一所附卫生部1985年8月5日关于医疗卫生事业工作人员工资制度改革实施方案第二部分第(六)项的规定执行的范围、对象,是否只限于卫生系统和各行业医疗卫生部门吸收录用的国家正式职工。经研
究答复如下:
乡村医生(原赤脚医生)被招收、顶替、录用为国家正式职工或进入各级医药院校学习毕业(结业)后,成为国家正式职工,并继续从事卫生工作的,其成为国家正式职工前最后一次经组织批准任乡村医生的工作时间(含其原当赤脚医生的工作时间)可以与成为国家正式职工后的工作
时间合并计算为连续工龄。在两个以上单位连续担任乡村医生(原赤脚医生)的时间,凡经正当手续调动的,应当合并计算为连续工龄。



1986年3月21日

中华人民共和国民用航空器适航管理条例(附英文)

国务院


中华人民共和国民用航空器适航管理条例(附英文)

1987年5月4日,国务院

第一条 为保障民用航空安全,维护公众利益,促进民用航空事业的发展,特制定本条例。
第二条 在中华人民共和国境内从事民用航空器(含航空发动机和螺旋桨,下同)的设计、生产、使用和维修的单位或者个人,向中华人民共和国出口民用航空器的单位或者个人,以及在中华人民共和国境外维修在中华人民共和国注册登记的民用航空器的单位或者个人,均须遵守本条例。
第三条 民用航空器的适航管理,是根据国家的有关规定,对民用航空器的设计、生产、使用和维修,实施以确保飞行安全为目的的技术鉴定和监督。
第四条 民用航空器的适航管理由中国民用航空局(以下简称民航局)负责。
第五条 民用航空器的适航管理,必须执行规定的适航标准和程序。
第六条 任何单位或者个人设计民用航空器,应当持航空工业部对该设计项目的审核批准文件,向民航局申请型号合格证。民航局接受型号合格证申请后,应当按照规定进行型号合格审定;审定合格的,颁发型号合格证。
第七条 任何单位或者个人生产民用航空器,应当具有必要的生产能力,并应当持本条例第六条规定的型号合格证,经航空工业部同意后,向民航局申请生产许可证。民航局接受生产许可证申请后,应当按照规定进行生产许可审定;审定合格的,颁发生产许可证,并按照规定颁发适航证。
任何单位或者个人未按照前款规定取得生产许可证的,均不得生产民用航空器。但本条例第八条规定的除外。
第八条 任何单位或者个人未取得生产许可证,但因特殊需要,申请生产民用航空器的,须经民航局批准。
按照前款规定生产的民用航空器,须经民航局逐一审查合格后,颁发适航证。
第九条 民用航空器必须具有民航局颁发的适航证,方可飞行。
民航局颁发的适航证应当规定该民用航空器所适用的活动类别、证书的有效期限及安全所需的其他条件和限制。
第十条 持有民用航空器生产许可证的单位生产的民用航空器,经国务院有关主管部门批准需要出口时,由民航局签发出口适航证。
第十一条 在中华人民共和国境内飞行的民用航空器必须具有国籍登记证。在中华人民共和国注册登记的民用航空器,具有中华人民共和国国籍,国籍登记证由民航局颁发。民用航空器取得国籍登记证后,必须按照规定在该民用航空器的外表标明国籍登记识别标志。
第十二条 中华人民共和国的任何单位或者个人进口外国生产的任何型号的民用航空器,如系首次进口并用于民用航空活动时,出口民用航空器的单位或者个人必须向民航局申请型号审查。民航局接受申请后,应当按照规定对该型号民用航空器进行型号审查;审查合格的,颁发准予进口的型号认可证书。
第十三条 中华人民共和国的任何单位或者个人租用的外国民用航空器,必须经民航局对其原登记国颁发的适航证审查认可或者另行颁发适航证后,方可飞行。
第十四条 任何单位或者个人的民用航空器取得适航证以后,必须按照民航局的有关规定和适航指令,使用和维修民用航空器,保证其始终处于持续适航状态。
第十五条 加装或者改装已取得适航证的民用航空器,必须经民航局批准,涉及的重要部件、附件必须经民航局审定。
第十六条 中华人民共和国境内和境外任何维修单位或者个人,承担在中华人民共和国注册登记的民用航空器的维修业务的,必须向民航局申请维修许可证,经民航局对其维修设施、技术人员、质量管理系统审查合格,并颁发维修许可证后,方可从事批准范围内的维修业务活动。
第十七条 负责维修并放行在中华人民共和国注册登记的民用航空器的维修技术人员,必须向民航局提出申请,经民航局或者其授权单位考核合格并取得维修人员执照或者相应的证明文件后,方可从事民用航空器的维修并放行工作。
第十八条 民用航空器的适航审查应当收取费用。收费办法由民航局会同财政部制定。
第十九条 民航局有权对生产、使用、维修民用航空器的单位或者个人以及取得适航证的民用航空器进行定期检查或者抽查;经检查与抽查不合格的,民航局除按照本条例的有关规定对其处罚外,还可吊销其有关证件。
第二十条 使用民用航空器进行飞行活动的任何单位或者个人有下列情形之一的,民航局有权责令其停止飞行,并视情节轻重,处以罚款:
一、民用航空器未取得适航证的;
二、民用航空器适航证已经失效的;
三、使用民用航空器超越适航证规定范围的。
第二十一条 维修民用航空器的单位或者个人,有下列情形之一的,民航局有权责令其停止维修业务或者吊销其维修许可证,并视情节轻重,处以罚款:
一、未取得维修许可证,擅自承接维修业务的;
二、超过维修许可证规定的业务范围,承接维修业务的;
三、由未取得维修人员执照的人员负责民用航空器的维修并放行的。
第二十二条 任何单位或者个人违反本条例第七条规定,擅自生产民用航空器的,民航局有权责令其停止生产,并视情节轻重,处以罚款。
第二十三条 按照本条例受到处罚的单位的上级主管机关,应当根据民航局的建议对受罚单位的主要负责人或者直接责任人员给予行政处分;情节严重,构成犯罪的,由司法机关依法追究刑事责任。
第二十四条 民航局因适航管理工作的过失造成人身伤亡或者重大财产损失的,应当承担赔偿责任,并对直接责任人员给予行政处分;直接责任人员的行为构成犯罪的,由司法机关依追究刑事责任。
第二十五条 民航局从事适航管理的工作人员,利用职务之便营私舞弊的,应当给予行政处分;情节严重,构成犯罪的,由司法机关依法追究刑事责任。
第二十六条 任何单位或者个人对民航局作出的罚款决定不服的,可以在接到罚款通知书之日起十五日内向民航局提请复议,也可以直接向人民法院起诉;期满不提请复议也不起诉又不执行的,民航局可以申请人民法院强制执行。
第二十七条 民航局应当在广泛征求航空工业部及各有关部门意见的基础上,制定本条例的实施细则及有关技术标准。
第二十八条 本条例由民航局负责解释。
第二十九条 本条例自一九八七年六月一日起施行。

REGULATIONS OF THE PEOPLE'S REPUBLIC OF CHINA FOR THE ADMINISTRA-TION OF THE AIRWORTHINESS OF CIVIL AIRCRAFT

Important Notice: (注意事项)
英文本源自中华人民共和国务院法制局编译, 中国法制出版社出版的《中华人民
共和国涉外法规汇编》(1991年7月版).
当发生歧意时, 应以法律法规颁布单位发布的中文原文为准.
This English document is coming from the "LAWS AND REGULATIONS OF THE
PEOPLE'S REPUBLIC OF CHINA GOVERNING FOREIGN-RELATED MATTERS" (1991.7)
which is compiled by the Brueau of Legislative Affairs of the State
Council of the People's Republic of China, and is published by the China
Legal System Publishing House.
In case of discrepancy, the original version in Chinese shall prevail.

Whole Document (法规全文)
REGULATIONS OF THE PEOPLE'S REPUBLIC OF CHINA FOR THE ADMINISTRA-
TION OF THE AIRWORTHINESS OF CIVIL AIRCRAFT
(Promulgated by the State Council on May 4, 1987)
Article 1
These Regulations are formulated for the purpose of ensuring safety in
civil aviation, protecting public interests and promoting the development
of civil aviation undertakings.
Article 2
All units or individuals that are engaged in the designing, manufacturing,
use and maintenance of civil aircraft (including aircraft engines and
propellers, and the same hereinafter) within the People's Republic of
China, all units or individuals that export civil aircraft to the People's
Republic of China, and all units or individuals that perform outside the
People's Republic of China maintenance services to aircraft registered in
the People's Republic of China shall abide by these Regulations.
Article 3
The administration of the airworthiness of civil aircraft denotes the
technical appraisal and supervision exercised in accordance with the
pertinent provisions of the State over the designing, manufacturing, use
and maintenance of civil aircraft for the purpose of ensuring safety in
flight.
Article 4
The Civil Aviation Administration of China (hereinafter referred to as the
"CAAC") shall be responsible for the administration of the airworthiness
of civil aircraft.
Article 5
The administration of the airworthiness of civil aircraft shall be
exercised in accordance with the prescribed airworthiness criteria and
procedures.
Article 6
Any units or individuals that intend to design civil aircraft shall, on
the strength of the document issued by the Ministry of Aeronautic Industry
for the examination and approval of the design project, apply to the CAAC
for a Certificate of Up-to-Standard Model. The CAAC shall, after receipt
of the application therefor, conduct the examination and appraisal, in
accordance with the relevant provisions, as to whether the model to be
designed is up to standard and, if the model is proved to be up to
standard, a Certificate of Up-to-Standard Model shall be issued.
Article 7
Any units or individuals that intend to manufacture civil aircraft shall
have the necessary manufacturing capacity and shall, on the strength of
the Certificate of Up-to-Standard Model as prescribed in Article 6 of
these Regulations and with the consent of the Ministry of Aeronautic
Industry, apply to the CAAC for a Manufacturing Permit. The CAAC shall,
after receipt of the application therefor, conduct examination and
appraisal, in accordance with the relevant provisions, as to whether the
applicants are qualified to obtain a Manufacturing Permit, if they are
proved to be qualified, a Manufacturing Permit shall be issued to them,
together with an Airworthiness Certificate to be issued in accordance with
the relevant provisions.
No units or individuals that have not obtained a Manufacturing Permit in
accordance with the provisions of the preceding paragraph may manufacture
civil aircraft, except as otherwise prescribed in the provisions of
Article 8 of these Regulations.
Article 8
Any units or individuals that have not obtained a Manufacturing Permit but
intend to manufacture civil aircraft as a result of special needs shall
apply to the CAAC for approval. Civil aircraft manufactured in accordance
with the provision in the preceding paragraph shall be examined one by one
and only after each of them is proved to be up to standard shall an
Airworthiness Certificate be issued.
Article 9
Civil aircraft may engage in flight operations only when they have
possessed an Airworthiness Certificate issued by the CAAC.
The Airworthiness Certificate issued by the CAAC shall specify the type(s)
of activities the aircraft is (are) good for, the period of validity of
the Certificate, and other conditions and restrictions required for
ensuring safety.
Article 10
If civil aircraft manufactured by units possessing a Civil Aircraft
Manufacturing Permit are to be exported as approved by the competent
authorities under the State Council, the Airworthiness Certificate for
Export shall be issued by the CAAC.
Article 11
Civil aircraft that are to fly within the People's Republic of China must
possess Nationality Registration Certificates. Civil aircraft that have
been registered in the People's Republic of China shall bear the
nationality of the People's Republic of China and shall be issued
Nationality Registration Certificate by the CAAC. Civil aircraft shall,
after obtaining a Nationality Registration Certificate, stencil on their
outer surface the identification marks of nationality registration in
accordance with the relevant provisions.
Article 12
Where any units or individuals of the People's Republic of China intend to
import any model of civil aircraft manufactured in foreign countries, and
if it is imported for the first time and to be used for civil aviation
activities, the units or individuals exporting that civil aircraft shall
apply to the CAAC for examination of the model. The CAAC shall, upon
receipt of the application, conduct the examination of the model of the
civil aircraft in accordance with the relevant provisions. If the model is
proved to be up to standard, a Certificate for Model Approval shall be
issued to permit the import.
Article 13
A foreign civil aircraft leased by any unit or individual of the People's
Republic of China may engage in flight operations only after the CAAC has
examined and approved the airworthiness certificate issued by the country
of registry of the said aircraft or only after the CAAC has issued a new
Airworthiness Certificate to the aircraft.
Article 14
Any units or individuals that have obtained Airworthiness Certificates for
their civil aircraft shall, in accordance with the relevant provisions of
the CAAC and its mandates of airworthiness, use and maintain the said
civil aircraft and ensure that they are in a state of permanent
airworthiness.
Article 15
The addition or modification of a civil aircraft for which an
Airworthiness Certificate has been obtained shall be subject to the
approval of the CAAC and the essential components and accessories involved
shall be subject to the examination and approval of the CAAC.
Article 16
Any maintenance units or individuals inside or outside the People's
Republic of China that intend to undertake maintenance services for civil
aircraft registered in the People's Republic of China shall apply to the
CAAC for a Maintenance Permit. Only after the CAAC has examined their
maintenance facilities, technical personnel and quality control system,
found them up to standard and issued a Maintenance Permit may they engage
in the maintenance business activities within the scope approved.
Article 17
Maintenance technical personnel in charge of maintaining and releasing
civil aircraft registered in the People's Republic of China shall apply to
the CAAC and only after the CAAC or a unit authorized by the CAAC has
examined them and found them qualified and they have thus obtained a
Maintenance Personnel Licence or a similar certificate may they engage in
the maintenance and release of civil aircraft.
Article 18
Fees shall be charged for the examination of the airworthiness of a civil
aircraft. The amounts to be charged and relevant procedures for charging
shall be set by the CAAC in conjunction with the Ministry of Finance.
Article 19
The CAAC shall have the right to examine regularly or selectively the
units or individuals that manufacture, use or maintain civil aircraft, as
well as the civil aircraft for which Airworthiness Certificates have been
obtained. If they fail to pass the examination or selective examination,
the CAAC shall impose penalties on them in accordance with the relevant
provisions of these Regulations and may, in addition to that, revoke their
relevant documents.
Article 20
If any units or individuals that use civil aircraft for flight activities
are found in any one of the following circumstances, the CAAC shall have
the right to order them to suspend flight and impose a fine on them in
accordance with the seriousness of the case:
1. no Airworthiness Certificate has been obtained for the civil aircraft;
2. the Airworthiness Certificate of the civil aircraft has expired; or
3. the civil aircraft has been used beyond the scope prescribed in the
Airworthiness Certificate.
Article 21
If any units or individuals that maintain civil aircraft are found in any
of the following circumstances, the CAAC shall have the right to order
them to suspend the maintenance business or revoke their Maintenance
Permit and impose a fine on them in accordance with the seriousness of
case:
1. no Maintenance Permit has been obtained and yet maintenance business
has been procured without authorization;
2. maintenance business has been undertaken beyond the business scope
prescribed in the Maintenance Permit; or
3. personnel who have not obtained a Maintenance Personnel Licence have
been put in charge of the maintenance and release of civil aircraft.
Article 22
If any units or individuals, in violation of the provisions in Article 7
of these Regulations, manufacture civil aircraft without authorization,
the CAAC shall have the right to order them to suspend the manufacturing
and impose a fine on them in accordance with the seriousness of the case.
Article 23
The superior competent authorities in charge of the penalized units in
accordance with these Regulations shall, based on the proposal of the
CAAC, subject the principal persons in charge of the penalized units or
other persons directly responsible to administrative sanctions. If the
case is so serious as to constitute a crime, criminal liabilities shall be
investigated by the judicial organs in accordance with the law.
Article 24
If accidental death or bodily injury or heavy losses in property have
occurred as a result of negligence in the work of airworthiness
administration, the CAAC shall assume the liability for damages and
subject the persons directly responsible to administrative sanctions. If
the act of the persons directly responsible constitutes a crime, the
judicial organs shall investigate their criminal liabilities in accordance
with the law.
Article 25
The CAAC personnel engaged in airworthiness administration who take
advantage of their positions and powers to seek personal gains and graft
and corruption shall be subjected to administrative sanctions. If the case
is so serious as to constitute a crime, criminal liabilities shall be
investigated by the judicial organs in accordance with the law.
Article 26
Any units or individuals that do not accept the decision of the CAAC
concerning the imposition of a fine may, within 15 days of receipt of the
notice of the fine, apply to the CAAC for reconsideration or directly file
a suit with a people's court. If no application for reconsideration is
submitted or no suit is filed and yet the decision has not been executed
at the expiry of the prescribed period of time, the CAAC may apply to the
people's court for the enforcement of the decision.
Article 27
The CAAC shall, on the basis of the opinions widely solicited from the
Ministry of Aeronautic Industry and the various departments concerned,
formulate the rules for the implementation of these Regulations and the
relevant technical standards.
Article 28
The CAAC shall be responsible for the interpretation of these Regulations.
Article 29
These Regulations shall become effective as of June 1, 1987.