关于进一步做好药品地方标准品种再评价工作的通知
国家食品药品监督管理局
关于进一步做好药品地方标准品种再评价工作的通知
各省、自治区、直辖市药品监督管理局或卫生厅(局)药政处(局)、药检所、医药管理部门： 为了统一和提高药品质量标准，减少药品的低水平重复，卫生部原药政局曾于1990年对西药地方标准品种再评价工作进行了部署，又于1996和1998年进一步明确了该项工作的范围、计划、原则和要求，并委托国家药典委员会具体承办。目前已完成800多种西药地方标准品种再评价工作，取得了一定成效。 药品地方标准品种再评价是以整顿、治乱为主要目的的历史性专项工作，也是加强药品监督管理，保证人民用药安全有效的重要手段。国家药品监督管理局自运行以来，继续按照原定的计划安排，坚持药品安全有效的原则，紧紧依靠医药学专家，努力实现科学、公正、严谨，力求工作扎实、可靠。我局于1998年10月、11月，经由国家药典委员会组织对非抗生素类抗感染药、解热镇痛药共400余种地方标准品种进行了再评价。并依照"整顿一类，清理一类"的要求，对评价结果进行了整理并列出了准予通过；拟停止使用；需统一合并、调整处方；需补报材料；国家药典、部标准等已收载共五类品种的名单，现随文公布结果（见附件）。 1999年计划进行的药品地方标准品种再评价工作任务繁重，但目前仍有一部分地区对初审工作不够重视、把关不严，影响了整体工作的质量。为维护药品地方标准品种再评价工作的严肃性，真正使此项工作落在实处，特重申并明确要求如下： 一、严肃认真地做好初审工作 承担初审工作的部门要切实负起责任，按照已定工作部署，组织好本地区药品地方标准品种再评价的初审工作。初审完成后，要按品种类别整理汇总成表（包括品名、批准文号、生产单位、近三年的产量及经济效益情况、初审意见）或软盘，与品种申报材料一并在规定的时间内报国家药典委员会。品种申报材料应符合以下要求： （一）处方依据，药效学根据及临床疗效和不良反应等资料必须齐全、真实、可靠。 （二）地方特色和独家生产的品种要提供足以说明其疗效、不良反应等情况资料和依据。 （三）该品种现有质量水平及质量控制情况。 （四）建议该品种保留与否的理由必须充分、明确。 （五）其他需要说明的方面必须作详细说明。 二、对复审阶段工作的几点要求 复审阶段的组织工作仍由国家药典委员会负责并做到： （一）认真收集、整理、分析、汇总经地方初审后的地方标准品种申报材料。对材料不全者，通知其限期补充。材料合格的，提出需要专家评审的内容提要和品种名单，并组织专家评审。 （二）选择具有符合所评价品种的专业知识和丰富的临床医药学实践经验，能认真负责、科学公正地提出意见和问题的专家，参加药品地方标准品种评审工作。 （三）遵循药品的安全有效性、处方合理性、质量可控性原则，对药品地方标准品种进行实事求是的再评价。评价结论的理由和依据要充分、科学、合理。 （四）根据专家评审意见进行整理、归纳，报国家药品监督管理局审核、公布。 （五）承担结果公布后的有关后续工作。 三、评价结果的处理 （一）对准予通过的品种，其质量标准的制订、审核、报批，产品批准文号的核发等后续工作由国家药典委员会负责组织，报国家药品监督管理局药品注册司审批。 （二）拟停止使用的品种，自结果公布之日起两个月内，如有异议可以申诉。将足够证明该品种应该保留的理由和依据报国家药品监督管理局安全监管司。限期内如无异议，由省、自治区、直辖市药品监督管理部门取消该品种的批准文号，并登记造册（包括产品名称、批准文号、生产单位等）分别报国家药品监督管理局药品注册司、市场监督司、安全监管司备案。 （三）需补报材料的品种，经由国家药典委员会负责通知省、自治区、直辖市药品监督管理部门到所属企业，按要求准备材料。并于结果公布之日起两个月内，将补充材料报给国家药典委员会。逾期未报，又未说明原因的，按已不生产同上条意见处理。 （四）需统一、合并、调整处方的品种，其统一、合并、调整处方后的审核、验证、评价工作由国家药典委员会负责组织，报国家药品监督管理局安全监管司审批。 （五）国家药典或部颁标准已收载的品种，必须按药典或部颁标准组织生产、检验、销售和使用。该品种的地方标准自行废止。 为做好所余药品地方标准品种再评价工作，我局将在进一步完善药品地方标准品种再评价工作规则的基础上，对地方初审情况进行调研和抽查。 特此通知。 附件：非抗生素类抗感染药、解热镇痛药地方标准品种再评价结果 国家药品监督管理局 一九九九年四月五日' 文号：国药管安［1999］85号
国家计委印发《关于中外合资、合作经营企业产品以产顶进办法》的通知(附英文)
国家计委
国家计委印发《关于中外合资、合作经营企业产品以产顶进办法》的通知(附英文)
1987年10月19日，国家计委
通知
根据《国务院关于鼓励外商投资的规定》，我委拟定的《关于中外合资、合作经营企业产品以产顶进办法》，已经国务院批准，现印发给你们，请参照执行。
附：关于中外合资、合作经营企业产品以产顶进办法
第一条 根据《国务院关于鼓励外商投资的规定》，为鼓励外商投资兴办先进技术企业，帮助企业解决外汇收支平衡，特制定本办法。
第二条 本办法适用于能够提供国内需要的先进技术，从事新产品开发实行产品升级换代的生产型中外合资经营、合作经营企业（以下简称合资、合作企业）。
第三条 符合下列各项条件的，可申请以产顶进：
一、确属国内需要的技术先进的技术型的合资、合作企业的产品，投产初期，在实现国产化进程中，外汇平衡出现暂时困难的；
二、上述企业生产的产品属于目前和今后几年中央、地方和部门需要进口的；
三、申请以产顶进的产品规格、性能、交货期和技术服务，培训应符合国内用户的需要，产品必须经过国家级产品质量检测中心鉴定，确认达到同类进口商品的质量标准，原则上价格不高于当时的国际市场价格。
第四条 凡要求以产顶进的企业，在申报项目建议书的同时，提出以产顶进的申请。在报送项目可行性研究报告时，必须明确合资、合作企业产品的内外销比例，以及国产化的进度，并对以产顶进的可行性（包括分年顶替进口的产品数量和外汇金额）进行充分论证或评估。
第五条 按分级管理原则、合资、合作企业产品申请以产顶进、分别由中央、地方（部门）两级审批。中央审批的限额以上项目需要以产顶进的，由国家计委审批；地方和部门审批的限额以下项目需要以产顶进的，由地方计委和部门自行审批。
第六条 由国家计委审批的限额以上项目的以产顶进：
一、凡已列入国家批准的中长期中央进口计划的商品，除去对外已签长期贸易协议和必须安排进口的以外，还有可能供以产顶进的，在审批可行性研究报告时，可预批中央进口计划期内的以产顶进。
二、没有列入中长期中央进口计划的商品，原则上不预批的以产顶进。但在年度中央进口计划中有这类商品进口且能以产顶进时，企业可向国家计委提出申请，批准后，由经贸部办理只在当年有效的以产顶进手续。
三、没有列入中长期和年度中央进口计划的商品，如当年地方有进口，企业可向地方计委提出申请，经批准后，由地方经贸部门办理以产顶进手续。
第七条 由地方、部门审批的限额以下项目的以产顶进：
一、凡已列入本省、自治区、直辖市的中长期和年度进口计划内可供以产顶进的商品，可由省、自治区、直辖市计委参照中央的审批办法，预批和办理本地区进口计划期内的以产顶进。
二、没有列入本地区中长期或年度计划，但本地区或其他地区有进口的，可实行跨地区的以产顶进。企业可向进口这一商品的省、自治区、直辖市计委申报，经批准后，由该省、自治区、直辖市经贸部门办理以产顶进手续。
三、部门用自有外汇进口的商品，企业可直接向该部门申请，经同意后，办理以产顶进手续。
第八条 上述中央和地方计委（或部门）审批同意以产顶进的产品，属于在中长期进口计划内预批的，必须根据当年的进口计划情况，在年度中进一步核定落实。
凡经批准实行以产顶进的产品，国内用户在同等条件下，必须优先选用。
各级进口管理部门和进口审查部门，对合资、合作企业已能生产并符合以产顶进条件的产品，应指导鼓励国内用户优先采购。
第九条 经批准的以产顶进产品，国内用户采购时，应按双方商定的条件，经国家外汇管理部门批准，向合资、合作企业支持全部或部分外汇。
第十条 机电产品的以产顶进，由国家经委制定并公布顶进目录和以产顶进管理办法，指导国内用户优先采购目录内的产品。
凡生产目录内产品的合资、合作企业可以参加中国机电设备招标中心（或经国家经委批准的招标公司）组织的进口机电设备招标，中标的企业，由该中心出具证明，实现以产顶进。
第十一条 合资、合作企业生产以产顶进产品所需进口的料、件、按《对外经济贸易部关于外商投资企业申领出口许可证的实施办法》第四条规定办理进口手续；上述产品供应给国内用户时，按海关总署《中华人民共和国海关对外商投资企业履行产品出口合同所需进口料、件管理办法》第五条规定办理。
第十二条 经批准其产品实行以产顶进合资、合作企业，必须做到：
一、严格执行合同中规定的出口比例和国产化进程的要求：
二、必须努力使产品的技术性能和质量保持先进水平；
三、按合同规定的数量、时间交货，因交货时间、交货数量和产品质量等问题造成用户经济损失者，要承担相应的经济责任。
四、为用户提供优质服务。
第十三条 合资、合作企业的产品一俟批准以产顶进后，不能再重复将这部分产品纳入国产物资分配计划。
第十四条 本办法由国家计委负责解释。
第十五条 本办法自公布之日起实行。
附：“七五”计划期间中央进口计划内可以实行以产顶进的商品目录
1．钢材
2．生铁
3．木材
4．铜
5．铝
6．锌
7．橡胶
8．化肥
9．木浆
10．腈纶
11．锦纶
12．人造丝
Measures for the Substitution of Importation by Products Manu-factured by Chinese-Foreign Equity Joint Ventures and Chinese-ForeignCooperative Joint Ventures
(Promulgated by the State Plan Commission on October 31, 1987)
Whole document
Measures for the Substitution of Importation by Products Manufactured by
Chinese-Foreign Equity Joint Ventures and Chinese-Foreign Cooperative
Joint Ventures
(Promulgated by the State Plan Commission on October 31, 1987)
Article 1
These measures are specially formulated pursuant to the "Provisions of
the State Council for the Encouragement of Foreign Investment" in order to
encourage foreign businessmen to invest in and establish technologically
advanced enterprises, and assist enterprises with foreign investment to
achieve a balance of foreign exchange receipts and payments.
Article 2
These measures are applicable to the productive Chinese-foreign equity
joint ventures and cooperative joint ventures (hereinafter "joint venture"
and "cooperative venture") which are capable of providing the advanced
technology needed by the country and involve in developing new products
and upgrading the existing products.
Article 3
Applications for import substitution treatment may be made if the
following conditions are met:
1. Temporary difficulties in balancing foreign exchange in the initial
period of operation are encountered in respect of the product made by a
joint venture or cooperative venture which has advanced technology needed
by the country and which is in the process of localizing source;
2. The products produced by the above mentioned enterprises are need
to be imported at present and will be needed to be imported in the next
few years by central and local authorities and relevant departments; and
3. The specification, performance, term of delivery and the conditions
of technical service and training of those products applied for import
substitution should meet the requirements of domestic customers, and the
products must be confirmed to reach the same quality standard as import
products of the same kind after being tested by a State-level product
quality examination center, and in principle, the prices are not higher
than current prices in international market.
Article 4
All enterprises which intending to ask for import substitution shall
request import substitution in the project proposal submitted for
examination and approval. In the feasibility study report submitted for
examination and approval, the proportion of the products for export and
domestic-sales, and the degree for increasing the indigenous components
and parts of the products shall be clearly specified. The feasibility of
import substitution (including the quantity of import products and the
amounts of foreign exchange involved on a yearly basis) shall also be
fully demonstrated or assessed.
Article 5
In accordance with the principle of administrative separation, the
application for import substitution of products of joint ventures and
cooperative ventures should be examined and approved either by the central
authorities or by local authorities (or departments). As for the project
within the examination and approval limits of the central authorities,
the application for import substitution shall be examined and approved by
the State Planning Commission. As for the project within the examination
and approval limits of the local authorities or departments the
application for import substitution shall be examined and approved by the
local planning commission or departments themselves.
Article 6
Import substitution for the projects within the examination and
approval limits of the central authorities shall be examined and approved
by the State Planning Commission:
1. In the case of products listed in the Central medium or long-term
import plan, except for those products for which foreign long-term trade
agreements have already been signed and those products for which imports
must be arranged, import substitution may be approved in advance for the
period covered by the central import plan at the time the feasibility
study report is examined and approved.
2. In principle, advance approval shall not be given for import
substitution of products which are not listed in the Central medium or
long-term import plan. However, if such products are listed in the Central
annual import plan and import substitution is possible, the enterprises
may apply to the State Planing Commission for import substitution. After
approval is granted the formalities for import substitution shall be
handled by the Ministry of Foreign Economic Relations and Trade and shall
be valid for that given year only.
3. As for the products not listed in the central medium and long-term
or annual import plan, the enterprises may, where importation of the
products is to be made locally in the given year, apply to local planning
commission. After the approval is granted, the formalities for import
substitution shall be handled by the local departments of foreign economic
relations and trade.
Article 7
Import substitution for projects within the examination and approval
limits of local authorities should be examined and approved by the local
authorities and departments:
1. In the case that the products are listed in the medium and
long-term or annual import plan of provinces, autonomous regions and
municipalities directly under the Central Government and suitable for
import substitution, the planning commission of the provinces, autonomous
regions and municipalities directly under the Central Government can
approve import substitution in advance for the period covered by the local
import plan; reference shall be made to central examination and approval
measures.
2. In the case that the products are not listed in the medium and
long-term or annual import plan of one region, but such products is to be
imported into that-region or other regions, import substitution may be
conducted transregionally. The enterprises may apply directly to the
planning commission of provinces and autonomous regions and municipalities
directly under the Central Government which is importing the products.
After approval is granted, the import substitution formalities shall be
handled by the local departments of foreign economic relations and trade
of such province, autonomous region or municipality directly under the
Central Government.
3. In the case that the products imported by the departments using
their own foreign exchange, the enterprises may apply directly to such
department for import substitution. If such department consents, it shall
handle the import substitution formalities.
Article 8
The above mentioned products of import substitution which have been
approved by the State or local planning commission (or department) in
advance for the period covered by the medium and long-term plan, must be
further checked and ratified each year, in accordance with the situation
of such import plan in such year.
Under the same conditions, domestic users shall select and use the
products approved for import substitution in reference to imports.
All levels of import administration and import examination and
approval authorities shall provide guidance to domestic users and
encourage them to buy the products produced by joint ventures and
cooperative ventures which conform to the conditions of import
substitution, in reference to imports.
Article 9
Domestic users shall pay the foreign exchange to joint ventures and
cooperative ventures totally or partially when they buy products approved
for import substitution according to the conditions agreed by both parties
upon permission by the foreign exchange central authorities.
Article 10
The State Economic Commission shall draw up and promulgate a list of
mechanical and electric products of import substitution and relevant
administrative measures, and provide the guidance to the domestic users to
buy the products on the list, in reference to imports.
Joint ventures and cooperative ventures that produce the products on
such list, may enter bids in tenders organized by the China Machine and
Electrical Equipment Tendering Center (or other tendering companies
approved by the State Economic Commission). If an enterprise wins the
render, it may carry out the import substitution on the basis of the
certificate issued by the Center.
Article 11
The import procedures of the materials and parts which must be
imported by the joint ventures and cooperative ventures to produce the
import substitution products shall be handled according to the Article 4
of "Implementation Measures of the Ministry of Foreign Economic Relations
and Trade Concerning the Application for Import and Export Licenses by
Enterprises with Foreign Investment". When the products mentioned above
are supplied to domestic users, it shall be handled according to the
Article 5 of the" Measures of the Customs Authority of the People's
Republic of China for the Control of Materials and Parts Required to be
Imported for the Performance of Product Export Contracts by Enterprises
with Foreign Investment".
Article 12
The joint ventures and cooperative ventures whose products have been
approved for import substitution shall:
1. strictly carry out the contract requirements regarding the
proportion of export sales and the process of raising the indigenous
components and parts of the products,
2. strive maintain the technical performance and quality of the
products at the world advanced levels; and
3. deliver the products according to the quantity and the time
required in the contract. The enterprises which cause economic losses to
users because of problems in the amount or quality of products or the
delivery time, etc., shall bear corresponding economic responsibility.
4. provide the best service to users.
Article 13
Once the products of joint ventures and cooperative ventures being
approved for import substitution, such products shall not be included in
the allocation plan of the materials produced in domestic.
Article 14
The State Planning Commission shall be responsible for interpreting
these Measures.
Article 15
These Measures shall enter into force on the date of promulgation.
