境外投资外汇管理办法(附英文)
国家外汇管理局
境外投资外汇管理办法(附英文)
（1989年2月5日国务院批准）
办法
第一条 为了促进对外经济技术合作，加强境外投资外汇管理，有利于国际收支平衡，制定本办法。
第二条 本办法所称境外投资是指在中国境内登记注册的公司、企业或者其他经济组织（不包括外商投资企业）在境外设立各类企业或者购股、参股（以下统称境外投资企业），从事生产、经营的活动。
境外投资有关外汇事宜，依照本办法的规定执行。
第三条 拟在境外投资的公司、企业或者其他经济组织，在向国家主管部门办理境外投资审批事项前，应当向外汇管理部门提供境外投资所在国（地区）对国外投资的外汇管理情况和资料，提交投资外汇资金来源证明，由外汇管理部门负责投资外汇风险审查和外汇资金来源审查，并于三十天内作出书面审查结论。
第四条 经批准在境外投资的公司、企业或者其他经济组织（以下简称境内投资者），应当持下列材料向外汇管理部门办理登记和投资外汇资金汇出手续：
（一）国家主管部门的批准文件；
（二）外汇管理部门关于投资外汇风险审查和外汇资金来源审查的书面结论；
（三）投资项目的合同或者其他可证明境内投资者应当汇出外汇资金数额的文件。
办理前款登记和投资外汇资金汇出手续时，外汇管理部门应当对境内投资者的投资外汇资金来源进行复核。
第五条 境内投资者在办理登记时，应当按汇出外汇资金数额的5％缴存汇回利润保证金（以下简称保证金）。保证金应当存入外汇管理部门指定银行的专用帐户。汇回利润累计达到汇出外汇资金数额时，退还保证金。保证金存款的利息按照国家规定标准支付给境内投资者。
境内投资者缴存保证金确有实际困难的，可向外汇管理部门作出书面承诺，保证境外投资企业按期汇回利润或者其他外汇收益。
第六条 境内投资者来源于境外投资的利润或者其他外汇收益，必须在当地会计年度终了后六个月内调回境内，按照国家规定办理结汇或者留存现汇。未经外汇管理部门批准，不得擅自挪作他用或者存放境外。
第七条 境内投资者从境外投资企业分得的利润或者其他外汇收益，自该境外投资企业设立之日起五年内全额留成，五年后依照国家有关规定计算留成。
第八条 境外投资企业可以根据经营需要，自行筹措资金，但未经国家外汇管理局批准，其境内投资者不得以任何方式为其提供担保。
第九条 境外投资企业的年度会计报表，包括资产负债表、损益计算书，在当地会计年度终了后六个月内，由其境内投资者向外汇管理部门报送。
第十条 境外投资企业变更资本，其境内投资者应当事先报经原审批部门批准并报送外汇管理部门备案。
第十一条 境内投资者转让境外投资企业股份，应当向外汇管理部门提交股分转让报告书，并在转让结束后三十天内将所得外汇收益调回境内。
第十二条 境外投资企业依照所在国（地区）法律停业或者解散后，其境内投资者应当将其应得的外汇资产调回境内，不得擅自挪作他用或者存放境外。
第十三条 境外投资企业未按利润计划汇回利润或者其他外汇收益的，其境内投资者应当向外汇管理部门提交不能按时完成利润计划或者经营亏损的报告书。如无正当理由，外汇管理部门可从保证金中将相应比例的外汇数额结售给国家；未开立保证金帐户的，从其境内投资者的留成外汇中扣除相应数额上缴国家，但累计扣除数额不超过汇出外汇资金数额的20％。
第十四条 违反本办法第六条、第十一条、第十二条规定者，外汇管理部门应当责令境内投资者限期调回，并可按应调回资金数额的10％至20％处以外汇罚款。
违反本办法第九条、第十条规定，情节严重者，外汇管理部门对境内投资者可处以人民币十万元以下的罚款。
违反本办法其他条款规定者，依照《违反外汇管理处罚施行细则》的规定外理。
第十五条 本办法施行前已设立的境外投资企业，其境内投资者应当自本办法施行之日起六十天内，依照本办法的有关规定，向外汇管理部门补报有关材料，办理登记手续，并依照规定将外汇收益调回境内。
第十六条 本办法由国家外汇管理局负责解释。
第十七条 本办法自发布之日起施行。(附英文)
PROCEDURES FOR THE ADMINISTRATION OF THE FOREIGN EXCHANGE INVOLVEDIN INVESTMENT ABROAD
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)
PROCEDURES FOR THE ADMINISTRATION OF THE FOREIGN EXCHANGE INVOLVED
IN INVESTMENT ABROAD
(Approved by the State Council of the People's Republic of China
on February 5, 1989 and promulgated by the State Administration of Foreign
Exchange Control on March 6, 1989)
Article 1
These Procedures are formulated for the purpose of promoting economic and
technological co-operation with foreign countries, strengthening the
administration of the foreign exchange involved in investment abroad and
facilitating the achievement of a balance of international payments.
Article 2
The terms "investment abroad" referred to in these Procedures means the
establishment of various kinds of enterprises abroad or the purchase of
and holding shares abroad (hereinafter collectively referred to as
"Chinese-invested enterprises abroad") by corporations, enterprises and
other economic organizations registered inside China (not including
enterprises with foreign investment) to engage in production and business
activities. Matters related to the foreign exchange involved in investment
abroad shall be governed by these Procedures.
Article 3
Corporations, enterprises or other economic organizations that intend to
make investment abroad shall, prior to going through the procedures of
application, examination and approval of investment abroad with the
competent State authorities, provide the department for control of foreign
exchange with the information on the administration exercised by the
countries (or regions) where their investment is to be over the foreign
exchange involved in investigated by foreign countries and the relevant
data, and submit to the department the certifying documents on the
source(s) of the funds in foreign exchange earmarked for investment
abroad. The department for control of foreign exchange shall be
responsible for the risk examination of the foreign exchange earmarked for
investment abroad and for the examination of the source(s) of the funds in
foreign exchange and shall present within 30 days the conclusions in
writing drawn from the examinations.
Article 4
Corporations, enterprises or other economic organizations (hereinafter
referred to as "domestic investors") that have been permitted to make
investment abroad shall handle with the department for control of foreign
exchange the procedures of registration and of remitting abroad the funds
in foreign exchange earmarked for investment abroad by presenting the
following materials:
1. the documents of approval issued by the competent State authorities;
2. the conclusions in writing drawn by the department for control of
foreign exchange from the risk examination of the foreign exchange
earmarked for investment abroad and the examination of the source(s) of
the funds in foreign exchange; and
3. the contract of the investment project or other document(s) that may
serve to certify the amount of the funds in foreign exchange that the
domestic investors shall remit abroad.
In handling the procedures of registration and of remitting abroad the
funds in foreign exchange earmarked for investment abroad as prescribed in
the first paragraph of this Article, the department for control of foreign
exchange shall re-examine the source(s) of the funds in foreign exchange
of the domestic investors.
Article 5
In going through the procedures of registration, the domestic investors
shall place a deposit as a guarantee that they shall remit the profit back
to China (hereinafter referred to as "guarantee deposit") which is equal
to 5 percent of the amount of funds in foreign exchange to be sent abroad.
The guarantee deposit shall be placed in a special account in a bank
designated by the department for control of foreign exchange. The
guarantee deposit shall be refunded when the total amount of profit
remitted back to China is equal to the amount of funds in foreign exchange
sent abroad. The interest on the guarantee deposit shall be paid to the
domestic investors in accordance with the standard rate prescribed by the
State.
If the domestic investors experience real difficulty in placing the
guarantee deposit, they may give a written commitment to the department
for control of foreign exchange that the enterprise abroad in which they
invest shall remit regularly the profit or other incomes in foreign
exchange back to China.
Article 6
The profit or other incomes in foreign exchange derived by domestic
investors from their investment abroad shall be repatriated within 6
months as of the end of the local accounting year and settled as foreign
exchange or retained as spot exchange in accordance with the pertinent
provisions of the State. Without the approval by the department for
control of foreign exchange, they may not be diverted to other uses or
kept abroad.
Article 7
The share of profit or other incomes in foreign exchange that domestic
investors receive from the enterprise abroad in which they invest shall be
retained in full in the first five years as of the date of the
establishment of the enterprise and shall be retained at a percentage
calculated in accordance with the pertinent provisions of the State as of
the end of the first five years.
Article 8
A Chinese-invested enterprise abroad may, on the basis of the need of its
business operations, raise funds on its own. But without approval by the
State Administration of Foreign Exchange Control, its domestic investors
may not provide guarantee for it by any means.
Article 9
The annual accounting statements of a Chinese-invested enterprise abroad,
including the statement of assets and liabilities and the statement of
loss and profit, shall, within 6 months as of the end of the local
accounting year, be submitted by its domestic investors to the department
for control of foreign exchange.
Article 10
If a Chinese-invested enterprise abroad is to make changes in its capital,
its domestic investors shall apply in advance to the original examining
and approving authorities for approval and the changes shall be reported
to the department for control of foreign exchange for the record.
Article 11
If domestic investors are to transfer the shares of stock of the
enterprise abroad in which they invest, they shall submit to the local
department for control of foreign exchange a report for the transfer
thereof and shall repatriate the incomes in foreign exchange thus obtained
within 30 days after the completion of the transfer.
Article 12
If a Chinese-invested enterprise abroad terminates its business operations
or is dissolved in accordance with the laws of the country (or region) in
which it is located, its domestic investors shall repatriate the assets in
foreign exchange that they are entitled to obtain and may not divert them
to other uses or keep them abroad without authorization.
Article 13
If a Chinese-invested enterprise abroad fails to remit back to China their
profit or other incomes in foreign exchange in accordance with their
profit plan, its domestic investors shall submit to the department for
control of foreign exchange a report on their failure to fulfil their
profit plan on schedule or on the losses sustained in business operations.
If they fail to offer sufficient justification, the department for control
of foreign exchange may deduct from their guarantee deposit a
corresponding proportion of foreign exchange and sell it to the State. If
the domestic investors have not opened a guarantee deposit account, the
department for control of foreign exchange shall deduct from their
retained foreign exchange a corresponding amount and turn it over to the
State, but the total amount deducted shall not exceed 20 percent of the
amount of the funds in foreign exchange that has been remitted abroad.
Article 14
If domestic investors violate the provisions in Articles 6, 11 and 12, the
department for control of foreign exchange shall order them to repatriate
the foreign exchange involved within a prescribed period of time and may
impose a fine amounting from 10 percent up to 20 percent of the amount
that should be repatriated.
If domestic investors violate the provisions in Articles 9 and 10 to a
serious extent, the department for control of foreign exchange may impose
on them a fine of Renminbi 100,000 yuan or less.
Violators of the other provisions of these Procedures shall be dealt with
in accordance with the provisions of the Rules for the Implementation of
Penalties on Violations of Foreign Exchange Control.
Article 15
The domestic investors of the Chinese-invested enterprise abroad
established before these Procedures go into effect shall, within 60 days
starting from the day on which these Procedures go into effect and in
accordance with the relevant provisions of these Procedures, approach the
department for control of foreign exchange to make up for the submission
of the relevant materials and go through the procedures of registration
and shall repatriate their incomes in foreign exchange in accordance with
the relevant provisions.
Article 16
The State Administration of Foreign Exchange Control shall be responsible
for the interpretation of these Procedures.
Article 17
These Procedures shall go into effect as of the date of promulgation.
关于印发《进口药品注册检验指导原则》的通知
国家食品药品监督管理局
关于印发《进口药品注册检验指导原则》的通知
国食药监注[2004]310号
各口岸药品检验所：
为加强进口药品注册管理，保证进口药品注册检验工作的规范化，我局制订了《进口药品注册检验指导原则》，现印发你们，请认真贯彻执行。
附件： 1．国家食品药品监督管理局进口药品质量标准复核通知单
2．中国药品生物制品检定所进口药品质量标准复核通知件
3．国家食品药品监督管理局进口药品注册标准格式
4．国家食品药品监督管理局进口药品注册标准复核说明格式
国家食品药品监督管理局
二○○四年六月二十五日
进口药品注册检验指导原则
进口药品注册检验系指国家食品药品监督管理局指定口岸药品检验所对申请注册的进口药品质量标准的有效性和可行性进行复核及样品的实验室考核。为保证进口药品注册检验工作的规范化，特制订本指导原则。
一、进口药品注册检验程序及时限
（一）进口药品注册检验依据国家食品药品监督管理局药品注册司下发的《进口药品质量标准复核通知单》（附件1）进行。中国药品生物制品检定所具体负责组织实施。
（二）申请人在收到国家食品药品监督管理局药品注册司下发的《进口药品质量标准复核通知单》后，应将下列资料和样品，及时报送中国药品生物制品检定所：
1．申报品种的出厂及货架期的中、英文质量标准、检验方法及相关的生产工艺资料（文字资料及电子版资料各一份）；
2．三批已在国外或国内上市的样品及出厂检验报告书，每批为全检量的三倍量；生物制品可根据其品种要求，提供相应的半成品（原液）及其制造及检定记录；
3．检验用标准品（对照品）及检验报告书。
（三）中国药品生物制品检定所收到进口药品注册检验的资料和样品后，应在5个工作日内确定进行进口药品注册检验工作的口岸药品检验所，向有关口岸药品检验所下发《进口药品质量标准复核通知件》（附件2），并将质量标准和样品等一并发给承担工作的口岸药品检验所。
（四）承担工作的口岸药品检验所在收到《进口药品质量标准复核通知件》后，方可开始进行质量标准复核工作。复核工作应在收到《进口药品质量标准复核通知件》和相关资料及复核用样品、标准品后60个工作日内完成。
进口生物制品的注册检验由中国药品生物制品检定所负责，其注册检验及质量标准复核工作应当在60个工作日内完成，特殊制品及疫苗等制品的复核工作可在90个工作日内完成。如有特殊情况，应通知申请人，并说明原因。
（五）各口岸药品检验所完成所承担品种的质量标准复核工作后，应将复核后的质量标准、复核说明及检验报告书一式五份报中国药品生物制品检定所。同时应报送电子版的质量标准和复核说明，格式为Microsoft Word。
（六）中国药品生物制品检定所在收到口岸所报送的质量标准后，应在20个工作日内组织专家遵照复核原则，完成报送质量标准的审核。若报送的质量标准须做补充或修订，则应出具书面意见告知复核单位。复核单位应在规定时限内完成修订工作，并连同复核标准起草说明及检验报告书等及时呈报中国药品生物制品检定所。
（七）质量复核过程中发现药品质量问题的，由中国药品生物制品检定所负责提出处理意见及时上报国家食品药品监督管理局。
（八）经国家食品药品监督管理局审查批准注册的进口药品，其复核后的质量标准为进口药品注册标准，作为进口药品检验的法定标准。该标准由中国药品生物制品检定所按统一格式编号，编号格式为：JXxxxxxxxx、JZxxxxxxxx、JSxxxxxxxx（X代表化学药品；Z代表中药；S代表生物制品；数字的前四位为年份，后四位为序号）。
（九）经国家食品药品监督管理局批准的进口药品注册标准由中国药品生物制品检定所印发各口岸药品检验所，在进口药品口岸检验时使用。
二、质量标准的复核原则
（一）质量标准复核应严格按企业申报的货架期标准的内容进行复核，不可随意减少项目。
1．有关物质检查如果生产企业不能提供杂质对照品时，可请生产企业修订为自身对照法，但应同时提供响应因子、相对保留时间及检测灵敏度等方法学验证的数据。
2．含量测定项有两种或两种以上检测方法，应选择准确度高、重现性和专属性强、易于操作的一种方法；制剂应优先考虑能反映稳定性和专属性的方法。
3．口服制剂中的辅料、稳定剂、抗氧剂、包衣色素等，一般情况下在检验项目中可不作规定。
4．如申报品种的质量标准中检测项目涉及特殊仪器，且无其他方法代替时。可暂不检验。但应写入质量标准的正文，并加注“*”，“注明：此项目检查为特殊仪器，口岸检验暂不执行，以生产企业的自检报告结果为准”，并在相应的复核说明处写明原因。
（二）质量标准复核须考核该标准能否全面控制产品的质量。若该品种已收载于国际通用药典或世界卫生组织有关生物制品的规程，则应与国际通用药典的标准或世界卫生组织有关生物制品的规程进行比较。若该品种已在我国上市，则尚须与我国国家药品标准进行比较。若国际通用药典标准的限度不同，需经考核加以确定。
凡我国现行国家药品标准或《中国生物制品规程》已有规定的检验项目和质控指标，不论国外药典收载与否，复核标准都不得低于国家药品标准或《中国生物制品规程》的规定。
（三）修改原质量标准的有关项目、含量限度和检测方法要有充分理由；修改原检验方法，须按照《中国药典》现行版附录的指导原则进行方法学验证，与原检验方法进行对照，并提供试验数据。对质量标准项目、含量限度和检测方法的增加或者修改均应取得申请人的书面同意。
（四）已进行过质量标准复核的品种，再注册申请时，若我国现行国家药品标准对该品种已有新的规定，则应重新修订或增订检验项目。一般按照复核要求进行单项复核及检验，并对原复核标准进行审核修订，整理出完整的复核标准，并取得申请人的书面同意。
三、复核标准的撰写要求
（一）复核的质量标准须按照《中国药典》或《中国生物制品规程》的统一格式整理，并按照《国家食品药品监督管理局进口药品注册标准》（附件3）的格式打印，应用宋体四号字，并注明生产企业、生产国别及复核单位。
（二）质量标准复核应对申请注册的生产企业的三批样品进行检验，个别生物制品还需对三批样品的半成品（原液）进行复核，出具国内注册检验药品检验报告书。“检验目的”写为“注册检验”，“生产单位或产地”注明国别，“检验依据”写为“拟定进口注册标准”，其它均按药品检验报告书管理的有关规定执行。
四、起草说明的撰写要求
（一）质量标准复核起草说明按照《中国药典》或《中国生物制品规程》品种项下的项目次序，逐一加以说明。复核起草说明应包括对质量标准复核原则的执行情况、标准修改的原因、方法验证的数据、复核过程发现的情况和经验等。并按照《国家食品药品监督管理局进口药品注册标准复核说明》（附件4）的格式打印，应用宋体四号字。
（二）书写要求：
1．概况：写明进口药品中英文名称和商品名、生产企业和国别、申请人、申请编号及复核编号；对送检三批样品检验的结论意见。
2．重点介绍复核后的质量标准与原企业标准、国际通用药典、我国国家药品标准比较的情况，如有不同或有项目的增减，应详述理由。
3．对药品技术审评中提出的质量标准复核时需注意的问题及修订建议采纳情况的说明。没有采纳的应详述理由。
4．品名应根据《中国药品通用名称》或《中国生物制品规程》中《生物制品命名规则》进行命名（一般不标注商品名）。《中国药品通用名称》未收载的品种，应要求申请人出具国家药典委员会的命名复函。原料药必须注明结构式、分子式、化学名、英文通用INN名；单方制剂必要时注明主成分结构式、分子式、化学名、英文名；复方制剂须注明处方。
5．复核项目中若有对原方法进行修订或增加检测项目的，应按照《中国药典》或《中国生物制品规程》格式的顺序按以下要求加以说明。生物制品按《中国生物制品规程》的格式书写。
⑴性状：在复核过程中如有改动应加以说明。
⑵鉴别：
①若用薄层色谱法，应写清楚操作的条件及注意点，说明主斑点的Rf值，并提供薄层色谱图的照片或图谱。
②若增加或改用可见紫外吸收光谱特征，有最大吸收峰、最小吸收峰、肩峰等，应附图并且说明波长位置；有吸收度或吸收度比值，应写明检品的实测结果。
③其它对红外光谱、离子反应、高效液相色谱法等有修改的皆应加以说明。
⑶检查：
①对某些项目如pH、装量、重金属、溶液的澄清度和颜色、不溶性微粒、砷盐等有修改的应加以说明。
②对有关物质、降解产物、异构体、残留有机溶剂等检查项进行修改，如采用薄层色谱法应写明最低检出量，并附照片或图谱。如采用高效液相色谱法用杂质对照品时，应说明最低检测量，用自身对照或面积归一化法时，应附图并说明测试中色谱峰的分离度。
③若增加含量均匀度的测定，其检查方法应尽可能与含量测定相一致，如不一致应给予说明（或进行方法学验证）。
④若修订溶出度或释放度的测定：
a溶出度检查：说明过滤的方式，如过滤对样品有吸附，影响检测结果的，应加以说明。
b释放度检查：配制的溶剂或测试方法中有特殊要求的，均应在复核说明中加以说明。
⑷若重新制定含量测定方法：
①应写明测试中的注意事项及测试的结果。
②除容量分析法与重量分析法外，均应进行方法学验证实验。在制剂测定中，注意辅料是否干扰，并进行加样回收率试验，写明实验结果、色谱条件。
③采用高效液相色谱法测试含量时，应说明系统适用性试验的要求，给出复核实验条件下的系统适用性试验和典型图谱，如色谱柱有特殊要求，也应加以注明。
五、其它要求：
（一）申请注册品种若有多种规格的液体制剂，若主药浓度相同，可以根据具体情况复核一种规格的三批样品（生物制品可以仅复核最大装量的规格）；质量标准正文［规格］项下，按申请注册的规格全部列入。若主药浓度不一致，应复核申报的所有规格的各三批样品。
（二）送检的样品除特殊情况外，各复核单位不得擅自更换样品。送检的三批样品中如有样品按拟定的进口注册标准检验不符合规定，须连同拟定的进口注册标准报中国药品生物制品检定所，由中国药品生物制品检定所出具意见后上报国家食品药品监督管理局。
