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关于印发《可再生能源与新能源国际科技合作计划》的通知

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关于印发《可再生能源与新能源国际科技合作计划》的通知

科学技术部 国家发展和改革委员会


关于印发《可再生能源与新能源国际科技合作计划》的通知


国务院各部委、各直属机构有关司局,各省、自治区、直辖市、副省级市科技厅(委、局):

  根据《国家中长期科学和技术发展规划纲要(2006—2020年)》,为充分利用全球科技资源,提高我国可再生能源与新能源的基础研究水平,解决可再生能源与新能源发展中的关键科技问题,加强我国与世界各国在可再生能源与新能源方面的国际科技合作,推进可再生能源与新能源的国际化进程,科技部、国家发改委共同制定了《可再生能源与新能源国际科技合作计划》(见附件),现印发你单位,请结合各地实际,积极推动实施。

附件:可再生能源与新能源国际科技合作计划


科学技术部 国家发展和改革委员会

二〇〇七年九月二十二日


附件:可再生能源与新能源国际科技合作计划.pdf
International Science and Technology
Cooperation Program on New and Renewable Energy 0
目录/Contents
一、背景 ............................................................................. 4
I. Background .............................................................. 5
二、宗旨 ............................................................................ 8
II. Purposes .................................................................. 9
三、原则 ........................................................................... 10
III. Principles ............................................................. 11
四、目标 .......................................................................... 12
IV. Objectives ............................................................ 13
五、优先领域 ................................................................... 14
V. Priority Areas ........................................................ 15
六、重点任务 .................................................................. 16
VI. Major Tasks ......................................................... 17
七、组织与管理 .............................................................. 20
VII. Organization and Management .......................... 21
0 可再生能源与新能源国际科技合作计划
可再生能源与新能源
国际科技合作计划
可再生能源与新能源作为清洁、可持续利用的能
源,为解决人类未来能源供应问题提供了重要的途径和
手段。为提升可再生能源与新能源在中国和全球的发展
和应用技术水平,共同应对全球气候变化,节约能源资
源,实现经济社会可持续发展,建设和谐世界,加强中
国与世界各国在可再生能源与新能源方面的国际科技合
作,特制定“可再生能源与新能源国际科技合作计划”
(以下简称“计划”)。本计划所称可再生能源与新能
源主要包括太阳能、风能、生物质能、地热能、海洋能
以及氢能、天然气水合物等。
International Science and Technology
Cooperation Program on New and Renewable Energy 0
International Science and Technology
Cooperation Program on New and
Renewable Energy
As clean and sustainable resources, new and renewable energy
presents important solutions to future energy supply. The International
Science and Technology Cooperation Program on New and
Renewable Energy (hereinafter referred to as the Program) is
introduced with an aim to:
l advance the development and application of new and renewable
energy technologies in China and around the world;
l pool efforts to tackle global climate change, save energy resources
for sustainable socio-economic development and a harmonious world;
l and promote science and technology (S&T) cooperation between
China and other countries in this regard.
In the Program , the term “new and renewable energy” mainly refers to
solar energy, wind energy, biomass energy, geothermal energy, ocean
energy, hydrogen energy, gas hydrate, and the like.
0 可再生能源与新能源国际科技合作计划
背景
一、背景
当今社会主要依赖于传统的化石能源,全球总能耗
的74%来自煤炭、石油、天然气等矿物能源。化石能源
的应用推动了社会的发展,但资源却在日益耗尽。同时
化石能源的无节制使用,造成了严重的环境污染和气候
变化问题。世界各国纷纷把发展可再生能源与新能源作
为未来能源战略的重要组成部分,截止到目前,全球有
三十多个发达国家和十几个发展中国家制定了本国的可
再生能源发展目标。
各国都清楚地认识到,能源问题是一个全球性问
题,需要国际社会的共同努力。加强国际科技合作,
大力发展可再生能源与新能源,已经成为各国增加能源
供给,促进节能降耗,保障能源安全,减少温室气体排
放,发展低碳经济,实现经济与社会可持续发展的共同
选择。《京都议定书》的正式生效和清洁发展机制的提
出,为发展可再生能源与新能源,促进这一领域的国际
International Science and Technology
Cooperation Program on New and Renewable Energy 0
Background
I. Background
The current world is heavily dependent on fossil fuels which account
for 74% of the global energy consumption in the form of coal,
petroleum, natural gas, etc. Though providing momentum to social
progress, such resources are on the verge of exhaustion and their
excessive use has given rise to severe environmental pollution and
climate change. Hence countries around the world have identified
the development of new and renewable energy as an integral part of
their future energy strategies. Up till now, over 30 developed countries
and more than 10 developing countries have set national targets to
develop renewable energy.
It is widely acknowledged that the issue of energy concerns every
country and calls for joint efforts of the international community. It is
our common choice to intensify international S&T cooperation and
vigorously develop new and renewable energy so as to enhance
energy supply, save energy and reduce consumption, safeguard
energy security, cut down greenhouse gas emissions, foster the
low-carbon economy, and ensure sustainable socio-economic
development. The enforcement of the Kyoto Protocol and the Clean
Development Mechanism (CDM) has substantially invigorated
the international cooperation on new and renewable energy. With
growing public understanding and acceptance of the United Nations
Framework Convention on Climate Change (UNFCCC) , more and
more countries and international organizations will come to support
0 可再生能源与新能源国际科技合作计划
背景
合作提供了强大动力。随着人们对联合国《气候变化公
约》的深入理解和广泛接受,发展可再生能源与新能源
将会得到更多国家和国际组织的认同与支持。中国政府
为促进可再生能源与新能源的发展,出台了一系列的政
策与法规,公布实施了《可再生能源法》、《国家中长
期科学技术发展规划纲要(2006-2020年》,编制完成了
《可再生能源中长期发展规划》等,为中国发展可再生
能源与新能源提供了良好的制度环境,也为国际科技合
作创造了有利条件。
International Science and Technology
Cooperation Program on New and Renewable Energy 0
Background
the development of new and renewable energy. The Chinese
government has promulgated a series of laws and policies such as the
Law on Renewable Energy and the Outline of National Medium- and
Long-term Science and Technology Development Plan (2006-2020) ,
and formulated the Medium- and Long-Term Renewable Energy
Development Plan . Those are efforts aimed at creating a favorable
environment for tapping new energy and renewables in China and
facilitating international S&T cooperation.
0 可再生能源与新能源国际科技合作计划
宗旨
二、宗旨
通过国际科技合作向国际社会展示中国依靠科技创
新,积极发展可再生能源与新能源、减少温室气体排放和
建设资源节约型、环境友好型社会的决心,以及携手解决
世界未来能源问题的努力;通过选择国际领先和国内急需
的可再生能源与新能源科学技术开展国际科技合作,拓宽
引进先进技术的渠道,促进发达国家先进技术向发展中国
家转移以及发展中国家之间的技术转移,建立国际交流平
台,支持我国先进、实用的能源技术走向国际市场,推动
可再生能源与新能源科学技术的整体发展,促进各国先进
技术的融合;通过国际科技交流合作,积极引进可再生能
源与新能源的技术人才,提高中国可再生能源与新能源的
基础研究水平,解决可再生能源与新能源发展中的关键科
技问题;发展可再生能源与新能源产业,提高能源利用效
率,推进规模化利用程度,有效降低可再生能源与新能源
的使用成本;建立中国与世界各国政府、企业和科研机构
之间的对话、协商和沟通机制。
International Science and Technology
Cooperation Program on New and Renewable Energy 0
Purposes
II. Purposes
Through international S&T cooperation, China will demonstrate to
the international community her determination to explore new and
renewable energy, reduce greenhouse gas emissions, and build
a resource-conserving and environment-friendly society by S&T
innovation. China is also committed to joining hands with the world
in facing up to the future energy challenges. China will do her best
in the international efforts in developing world-class technologies for
new and renewable energy, and introduce technologies that meet
the urgent demand at home. The aim is to broaden channels for
technology introduction and facilitate the transfer of such technologies
from the developed to developing countries and among developing
countries as well. A platform for international exchanges is also to be
established to promote China’s advanced and appropriate energy
technologies to the global market, energize the overall S&T advances
in new and renewable energy and help create a synergy of advanced
technologies. International S&T cooperation is expected to bolster
China’s efforts to introduce technical professionals, upgrade the level
of basic research, and resolve key S&T issues in the field of new and
renewable energy. Moreover, such cooperation is to provide impetus
to the new and renewable energy industry, improve energy efficiency,
enhance large-scale use of new energies, and effectively bring down
their costs. Meanwhile, mechanisms for dialogue, consultation and
communication should be put in place to connect China with foreign
authorities, enterprises and research bodies.
10 可再生能源与新能源国际科技合作计划
原则
三、原则
合作互利共赢。结合世界各国可再生能源与新能源
的优势和特点,按照国际惯例,在科技领域广泛开展双
边和多边合作,互惠互利,合作共赢。
保护知识产权。在可再生能源与新能源的国际科技
合作中,要加强有利于科技进步和科技创新,有利于科技
成果的转化、应用和推广的先进技术的知识产权保护。
先进技术共享。在保护各自知识产权的基础上,加
强各国在可再生能源与新能源基础研究、技术研发、示
范和应用方面的交流与合作,鼓励我国先进新能源技术
进入国际交流平台,促进先进技术和科技资源共享。
集成优势资源。通过“引进来”、“走出去”和其
他新的资源组织方式,充分利用国际、国内两种资源,
提升中国可再生能源产业的技术水平和创新能力,同时
为国际新能源技术推广应用做出贡献。
开展技术创新。通过国际科技合作开展技术创新,
开发高效与环境友好的能源利用新技术,提高能源利用
的总体水平,推动能源新结构的转型与发展。
International Science and Technology
Cooperation Program on New and Renewable Energy 11
Principles
III. Principles
Mutually Beneficial and Win-Win Cooperation Bilateral and/or
multilateral S&T cooperation will be conducted in line with international norms
and by taking into account the advantages and characteristics of different
countries for the purpose of a mutually beneficial and win-win scenario.
Protection of Intellectual Property Rights The international S&T
cooperation in new and renewable energy should strengthen the
protection of intellectual property rights(IPR) of advanced technologies
that serve S&T progress and innovation, and the transformation,
application and dissemination of S&T achievements.
Sharing of Advanced Technologies On the basis that each party
protects its own IPR, exchanges and cooperation should be intensified
in the field of new and renewable energy, including basic research,
technology R&D, demonstration and application. The introduction
of China’s advanced technologies to the international exchange
platform should be encouraged and the sharing of the state-of-the-art
technologies and S&T resources should be promoted.
Integration of Strengths The “invite-in” and “go-out” endeavors,
along with other new approaches to mobilizing resources, should make
the best of resources at home and abroad to upgrade the technical level
and innovativeness of China’s renewable energy industry, and promote
the application of the world’s new energy technologies.
Technological Innovation International S&T cooperation is to
expedite technological innovation, develop new technologies that
utilize energy in an efficient and environment-friendly manner,
improve the comprehensive utilization of energy, and stimulate the
transformation towards new energy structures.
12 可再生能源与新能源国际科技合作计划
目标
四、目标
发展新的国际交流与合作模式,促进各国技术优
势互补,建立技术合作平台。在吸引国外先进技术向
中国转移的同时推动中国的先进技术走出去,加强与
发展中国家的科技合作;制定可再生能源与新能源国
际交流与合作技术指南,参与国际可再生能源与新能
源技术标准规范的制定;促进可再生能源与新能源技
术的引进、消化、吸收和再创新,与国外联合建立先
进技术应用示范项目;以企业为主体,强化产学研合
作,加快可再生能源与新能源科研成果的转化;建立
与发展一批大的示范项目,促进可再生能源与新能源
技术创新;因地制宜、多元化发展,建立可再生能源
与新能源国际科技合作基地,推进可再生能源与新能
源规模化发展;合作培养从事可再生能源与新能源研
究与开发的高层次专业人才队伍。
International Science and Technology
Cooperation Program on New and Renewable Energy 13
Objectives
IV. Objectives
Efforts should be made to develop new patterns for international
exchanges and cooperation, encourage countries to complement each
other with respective technological strengths, and set up a platform for
technological cooperation. When attracting the transfer of advanced
foreign technologies, China should also promote her advanced
technologies abroad and further the S&T ties with other developing
countries. A technical guide on the international interaction of new
and renewable energy will be formulated and China will take part in
setting the world’s technical standards. China is to do a better job in
introducing, digesting, and absorbing technologies from abroad, and
conducting re-innovation in new and renewable energy by teaming
up with foreign counterparts and running demonstration projects. It
is also important for China to identify enterprises as the major player
in the fortified industry-education-academia synergy, speed up the
transformation of research findings, initiate and advance a number
of big demonstration projects, and foster technological innovation in
new and renewable energy. In view of local conditions and diversified
developments, bases for international S&T cooperation in new
and renewable energy should be established to foster large-scale
development. Joint training will be carried out to nurture high-caliber
professionals for the R&D in the field of new and renewable energy.
14 可再生能源与新能源国际科技合作计划
优先领域
五、优先领域
重点支持以下领域的基础科学与应用技术研究。
(1)太阳能发电与太阳能建筑一体化
太阳能光热发电和光伏发电系统,薄膜太阳能电池
和其它新型太阳能电池,太阳能综合建筑,低成本、低
污染太阳能高纯硅材料生产技术,太阳能热利用技术工
业应用等。
(2)生物质燃料与生物质发电
非粮能源作物、纤维素原料乙醇、能源林业植物、生
物柴油、生物质成型燃料、生物质气化、沼气及发电等。
(3)风力发电
风能资源评估,大型高效风电机组,海上风电机组
及风电场建设等。
(4)氢能及燃料电池
制氢(太阳能、核能等)、储氢和输氢技术,新型
燃料电池与燃料电池汽车技术等。
(5)天然气水合物开发
天然气水合物勘探、开发、储运、利用技术等。
International Science and Technology
Cooperation Program on New and Renewable Energy 15
Priority Areas
V. Priority Areas
Support will be provided primarily to research on basic science and
applied technologies in the following fields:
1. Integration of Solar Power Generation and Solarpowered
Building Structures
solar thermal/photovoltaic power generation systems, thin-film PV
cells and other new types of PV cells, buildings integrated with solar
energy, low-cost and low-pollution production technology of high-purity
silicon materials, the industrial application of solar thermal technology
and so on.
2. Biomass Fuels and Biomass Power Generation
Non-food energy crops and ethanol from cellulose materials, energy
forestry, bio-diesel, biomass briquettes and biomass gasification,
biogas and power generation, and so on.
3. Wind Power Generation
Wind energy resources assessment, large high efficiency wind
turbines, offshore wind turbines and the building of wind farms.
4. Hydrogen Energy and Fuel Cells
Technologies for the production, storage and transportation of
hydrogen, and technologies for new types of fuel cells and fuel cell
automobiles.
5. Development of Gas Hydrates
Technologies for the exploration, development, storage, transportation,
and utilization of gas hydrates.
16 可再生能源与新能源国际科技合作计划
重点任务
六、重点任务
(1)开展基础研究
鼓励和支持中国研发机构与大学积极参与可再生能
源与新能源的国际合作研究与交流,开展新技术的基础
理论研究,显著增强基础科学和前沿技术研究的综合实
力,取得一批在世界上具有重大影响的科技理论成果。
(2)建立产业化示范
重点跟踪、引进和研究国际适宜低成本、规模化开发
利用可再生能源与新能源的先进技术,开展可再生能源资
源禀赋的系统评价及分布式可再生能源与新能源多能互补
系统等研发工作。可再生能源与新能源的发展是以现代制
造技术为基础的新型产业,因此要重点合作开发其装备设
计与制造技术,合作建立国际化的检测中心。
(3)面向规模应用
积极参与制定可再生能源与新能源的国际化和地区
性技术标准与规范,为新产品进入市场提前做好准备。
International Science and Technology
Cooperation Program on New and Renewable Energy 17
Major Tasks
VI. Major Tasks
1. Basic Research
Efforts should be made to encourage and support the active
participation of Chinese research institutes and universities in
international joint research and exchanges concerning new and
renewable energy, carry out basic theoretical studies on new
technologies, substantially enhance the overall capacity in basic
sciences and frontier technology studies, and accomplish a number of
S&T theoretical findings that are of high global impacts.
2. Industrial Demonstration
China is to stay focused on tracking, introducing and studying
advanced technologies that serve the cost-effective and large-scale
development and utilization of new and renewable energy, conduct
system appraisal of renewable resources endowment, and devote
R&D efforts to the distributed new and renewable energy systems
that provide multiple, mutually reinforcing forms of new energy. Given
that new and renewable energy presents a new type of industry that
is based on modern manufacturing technology, one cooperation
priority is to develop technologies for the design and manufacturing of
equipment, and set up international testing centers.
3. Scale Application
Play an active role in setting international and regional technical
standards related to new and renewable energy, and prepare for the
18 可再生能源与新能源国际科技合作计划
重点任务
交流和借鉴国外发展可再生能源与新能源的规划、政策
及管理经验,建立和完善中国的法规与管理制度。
(4)实施“走出去”战略
鼓励中国企业、研发机构和大学走出去,积极参与
国内外大型可再生能源与新能源合作项目,并在国内外
合作建立研发中心或基地,与有关国家建立可再生能源
与新能源长期合作伙伴关系,同时推动发达国家向发展
中国家及发展中国家之间的技术转移。
(5)促进国际交流和对话
建立与发展可再生能源与新能源国际科技合作对话
机制,交流在能源开发与利用方面的观点和经验,共同
探讨解决发展瓶颈的方法与策略。以论坛、研讨会、政
策对话等形式加强中国与世界各国政府、企业和科研机
构之间的对话、协商和沟通。
(6)培养高层次人才
利用合作研究项目、合作研究中心和示范工程等国
际科技合作交流平台,共同培养从事可再生能源与新能
源研发的高层次专业人才队伍。
International Science and Technology
Cooperation Program on New and Renewable Energy 19
Major Tasks
market entry of new products. Collaborate with foreign counterparts
and draw on their managerial expertise and experience in making
plans and policies for new and renewable energy, with a view to
establish and improve a Chinese regulatory and management system.
4. Pursue the “Go-out” Strategy
Efforts should be made to motivate Chinese enterprises, research
institutes and universities to go global and play active roles in big
cooperative projects in new and renewable energy, build up joint
R&D centers or bases, forge long-term cooperative partnerships with
countries concerned in this field, and stimulate technology transfer
from the developed to developing countries and among developing
countries.
5. Promote International Exchanges and Dialogues
It is important to develop dialogue mechanisms for international S&T
cooperation in new and renewable energy, in order to exchange ideas
of energy development and utilization, and pool efforts to look for
solutions to bottlenecks. Through various channels such as forums,
seminars and policy dialogues, China will be more engaged in the
dialogue, consultation and communication with foreign authorities,
enterprises and research bodies.
6. Nurture High-caliber Professionals
By taking advantage of joint research projects, joint R&D centers,
demonstration projects and other platforms for international S&T
cooperation, China aims to team up with foreign counterparts to
nurture high-caliber professionals for the R&D in the field of new and
renewable energy.
20 可再生能源与新能源国际科技合作计划
组织与管理
七、组织与管理
(1)成立计划组织机构
由国家科技部与国家发展与改革委联合协调有关
政府部门、国际组织和重要科研机构,组织实施“计
划”。成立“计划”国际科技合作指导委员会,启动国
际合作机制。
由科技部和国家发展与改革委联合组织,在全球范
围内聘请可再生能源领域的高层次专家,成立“计划”
国际科技合作专家咨询委员会,对“计划”的优先领
域、重点任务和合作方式提出咨询建议,供指导委员会
决策。
(2)设立专项资金
将安排专项资金启动“计划”,吸引外国政府和国
际组织的资金共同推动“计划”实施。同时重视吸引国
际大型能源企业以及其他企业和私营资本投入可再生能
源与新能源国际科技合作。
International Science and Technology
Cooperation Program on New and Renewable Energy 21
Organization and Management
VII. Organization and Management
1. Setting up an Organizing Agency
The implementation of the Program will be jointly organized by
the Ministry of Science and Technology (MOST) and the National
Development and Reform Commission (NDRC) of China, and carried
out by government agencies, international organizations and major
research institutes. A Steering Committee on International S&T
Cooperation will be established for the Program to initiate international
endeavors. MOST and NDRC will extend worldwide invitations to
high-level experts on new and renewable energy in a bid to establish
an Expert Consultation Committee on International S&T Cooperation
to provide the Steering Committee with suggestions on priority fields,
major tasks, and cooperation patterns of the Program.
2. Special Funds
Special funds will be arranged for the launch of the Program with
a view to attracting financial input from foreign governments and
international organizations for the implementation of the Program.
Equal attention will be given to soliciting private capital and investment
from the business sector, especially the international energy giants,
for the purpose of stimulating international S&T cooperation in the
field of new and renewable energy.

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沈阳市人民政府关于调整《沈阳市城市维护建设税征收管理暂行办法》中有关规定的通知

辽宁省沈阳市人民政府


沈阳市人民政府关于调整《沈阳市城市维护建设税征收管理暂行办法》中有关规定的通知


各县、区人民政府,市直各委、办、局(公司):
  为加强城市维护建设,根据目前我市的实际情况,市政府决定,将《关于印发〈沈阳市城市维护建设税征收管理暂行办法〉的通知》(沈政发〔1985〕79号)第 七 条第二项的规定,调整为“纳税人所在地在县城或郊区、县的镇以及较大工矿区的,税率为百分之五。”即《办法》中关于“暂不含后批准的十四个镇”的规定,停止执行。从本通知发布之日起,我市建制镇的城市维护建设税税率,均按百分之五征收。


关于进一步做好新兽药审批及生产审批工作的通知

农业部


关于进一步做好新兽药审批及生产审批工作的通知
农业部


(一九九三年十一月二十二日农业部发布)


各省、自治区、直辖市农牧(畜牧、农业、农林)厅(局):
为使新兽药审批工作逐步纳入科学化、规范化轨道,确保兽药产品安全有效,根据《兽药管理条例》、《新兽药及兽药新制剂管理办法》的有关规定,结合新兽药审批及生产审批工作中存在的问题,经认真研究,现对新兽药审批及生产审批做如下补充规定:
一、仿制国外已在我国注册的兽药产品;研制已有国家标准或企业标准的农药移植作兽用的原料药、单方及复方制剂;研制已有卫生部药典标准、地方药品标准的药品移植作兽用的单方及复方制剂;研制国家兽药标准兽药专业标准的兽药为改变其溶解度、提高稳定性而改变或增加其酸
根或硷基的兽药均按第三类(或二类)新兽药审批的有关规定报部,由部兽药管理部门审批并核发《新兽药证书》、兽药产品批准文号。
二、研制西兽药复方制剂、中西兽药复方制剂(其处方中各单味药为兽药典、兽药规范、兽药专业标准已收载或批准的)产品,研制单位按第三类新兽药审批的有关规定将技术资料、三批样品报当地省药政、药检管理部门审查并质量复核,由省药政管理部门将技术资料二份、质量标准
及起草说明、复核检验报告、审查意见报部,由部兽药管理部门审批并核发兽药产品批准文号。
三、已在我国注册的进口兽用原料药,需在国内加工生产、销售制剂的,由加工生产企业参照第一条规定办理审批,但不发《新兽药证书》,不享受新兽药生产期保护。
四、兽药典、兽药规范、兽药专业标准收载(新兽药生产保护期已过)的产品,如果增加适应症、改变剂型及给药途径,应由省兽药管理部门将产品生产工艺、临床药效、制剂稳定性、质量标准等技术资料报部兽药管理部门,经审核同意后再由省兽药管理部门核发产品批准文号、公布
质量标准。
五、兽药典、兽药规范、兽药专业标准已收载的兽用原料药,如改变其生产工艺或修改质量标准,应由生产厂提交申请报告并附有关资料报部审核同意后投产。改变兽药典、兽药规范、兽药专业标准规格(包括含量、装量)的兽药产品,应由省兽药管理部门将质量标准、有关情况说明
等材料报部,经审核同意后,再核发产品批准文号。
六、农业部核发新兽药证书的产品试产期两年,其质量标准为试行标准,试产期满前半年由生产单位提交产品稳定性、临床药效资料和工艺规程、标准执行情况及修改意见报部核查、履行试行标准转正手续,逾期不报的撤销其产品批准文号。
七、新兽药生产保护期内,除持新兽药证书副本生产厂外,各省兽药管理部门不得批准其他厂家生产该品种。如确在生产工艺上有重大改进,并且其质量指标明显优于已批准的新兽药,应按第一条规定报部审批,但不发给《新兽药证书》。
八、新兽药生产保护期内,新兽药研制单位及生产厂不得擅自再次进行技术转让,生产厂需凭新兽药证书副本申请批准文号,证书副本复印件无效。
九、为了使新兽药尽快投放市场,以保证防治畜禽疫病用药,对已批准的新兽药在保护期内一年未投产的,该新兽药的保护期即自行失效,我部将受理并批准其他厂家的新药申报和生产申请。
十、生产已超过新兽药保护期的产品(1992年以后批准的),各省兽药管理部门需在核发产品批准文号前将产品质量复核报告、生产工艺、生产厂概况及审核意见等资料报部备案。
十一、申报单位(生产厂)在新兽药申报期间不得以中试名义扩大产品使用规模及从事商业性销售。中试阶段的临床药效试验应在省级科研单位、大专院校进行,其试验方案需报部审核同意。中试扩大区域试验应在当地省兽药管理部门批准限定的区域半年以内完成。
十二、申报单位应如实向兽药审批部门提交有关资料,如发现并经查实有伪造、欺骗、弄虚作假或违反本规定行为的,我部将视情节轻重程度分别给予取消其申报资格,停发《新兽药证书》,通报批评,五年内不再受理其新兽药报批申请等处罚。
十三、本规定不包括兽用生物制品。
以上补充规定,请各省、自治区、直辖市药政、药检部门认真贯彻执行,共同维护新兽药管理的工作秩序。



1993年11月22日