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良好实验室规范(GLP)国际研讨会的讲话(中英文对照)

在良好实验室规范(GLP)国际研讨会上的讲话
Remarks at GLP International Promotion Seminar and GLP Inspectors Training Course
尊敬的DIAN Turnheim女士,各位专家,女士们、先生们:
Respected Ms. Dian Turnheim, distinguished specialists, ladies and gentlemen,
大家上午好!Good morning, everybody!
今天,很高兴能邀请到OECD环境、健康与安全署署长DIAN Turnheim女士, OCDE/GLP资深专家意大利的Caroli Sergio(先生)、美国的Francisca Liem(女士)、英国的Andrew Gray(先生)以及国家商务部、环保部、农业部、食药局、质检总局的各位领导和专家参加良好实验室规范(GLP)国际研讨会暨GLP检查员培训班,就国际GLP运作最新情况及中国如何更深入地参与OECD/GLP工作组活动进行深入交流和研讨。我谨代表国家认监委,对远道而来的OECD官员和专家、对与会的各部委代表和专家表示热烈的欢迎,对承办本次会议的中国合格评定国家认可中心和中国检验检疫科学研究院表示衷心感谢!
Today, at the GLP International Promotion Seminar and GLP Inspectors Training Course, we are very delighted to have with us Ms. Dian Turnheim, Head of Environment, Health and Safety Division, OECD, seasoned specialists on OECD/GLP Mr. Caroli Sergio from Italy, Ms. Francisca Liem from the United States, Mr. Andrew Gray from the United Kingdom, as well as leading officials and experts from the Ministry of Commerce, the Ministry of Environmental Protection, the Ministry of Agriculture, SFDA and AQSIQ. The participants will share their perspectives on and explore in an in-depth manner the latest international dynamics on the GLP front and how best China can engage more thoroughly in the activities of the OECD Working Group on GLP. On behalf of CNCA, I’d like to extend a warm welcome to OECD officials and specialists, who have traveled from afar, the representatives and experts from the participating agencies. I’d like to express my sincere thanks to the co-organizers of this event, China National Accreditation Service for Conformity Assessment (CNAS) and China Academy of Inspection and Quarantine (CAIQ).
近年来,随着贸易全球化,化工产品、农药、兽药及化妆品国际贸易迅速增长,化学品安全问题的影响日益严重,加强对化学品安全性的评估和监控,减少其对环境、人类和动植物健康安全带来的危害,已经成为全世界普遍的共识。
In recent years, the globalization of trade has been accompanied by a boom in international trade involving chemical products, pesticides, veterinary drug products and cosmetic products. The implications of chemicals safety have become increasingly serious. It has emerged as a global consensus to beef up assessment and monitoring of chemicals safety with a view to mitigating their harm to the environment, the health and safety of man, animals and plants.
在此,我特别想强调OECD/GLP/MAD 对于消除化学品国际贸易壁垒所发挥的作用。经合组织(OECD)安全性资料相互承认(MAD) 体系是一个多边协议,主要目的是促进登记资料要求的协调一致,减少昂贵的、重复的试验,避免非关税贸易壁垒,降低化学品登记成本,提高经济效益。MAD体系为政府和化学产品生产商对化学品安全检测结果提供信息共享,据OECD统计,每年为OECD成员国政府及化工企业至少节约6000万美元的评价费用。目前OECD 30 个成员国的安全性评价资料在该互认体系下已实现互认。由于这种资料互认具有互惠互利的优越性,非OECD 成员国家对该互认体系的兴趣日益增大,目前已经有南非、以色列、新加坡等非OECD国家成为OECD/GLP MAD的正式履约方。
On this occasion, I wish to lay particular emphasis the role of OECD/GLP/MAD in removing barriers to international trade in chemicals. The OECD’s Mutual Acceptance of Data system program represents a multilateral agreement, which is primarily intended to facilitate a harmonized approach to the registration of data, to reduce expensive and duplicative testing, to eliminate non-tariff trade barriers, to bring down the cost of registering chemicals and to boost economic benefits. The MAD system enables information sharing among governments and chemical product manufacturers with respect to the testing results of chemicals safety. OECD has reckoned that each year, the MAD system saves a minimum of 60 million U.S. dollars in assessment fees for governments and chemical businesses in OECD members. Currently, mutual recognition of safety assessment data among OECD’s 30 members has materialized under the MAD system. Given the mutual benefits that are derived from such data mutual recognition, non-OECD members have shown mounting interest in the MAD system. At present, non-OECD countries including South Africa, Israel and Singapore have become as full adherents to the OECD/GLP/MAD.
近几年来,中国也在密切关注OECD/GLP的工作进展。国家认监委作为中国的实验室资质管理部门,一直努力推动中国的GLP体系尽早纳入OECD/GLP MAD框架之中,以便在促进中国化工业界发展和保护中国环境的同时,降低国际贸易成本。这也是我们举办本次研讨会,邀请国内外专家交流学习,了解OECD/GLP MAD运作规则,探讨中国GLP体系的发展道路,加强中国与OECD成员国沟通与交流合作的原因之所在。
In recent years, China has also been following closely developments on the OECD/GLP front. As the competent authorities for the qualifications of labs in China, CNCA has been consistently pushing for an early incorporation of China’s GLP program into the framework of the OECD/GLP/MAD so that we will be able to cut the cost of international trade as well as spur growth in the country’s chemical industry and help protect the nation’s environment. That’s why we are running the current seminar, where domestic and international specialists are brought together to share their insight with and learn from each other. Through this event, we hope to learn more about the rules of the OECD/GLP MAD, explore a way forward for China’s GLP program, and strengthen China’s communication and cooperation with OECD members.
在这里,我想简要介绍一下国家认监委的职能,国家认监委于2001年经国务院批准成立并授权,统一管理、监督和综合协调全国的认证认可工作。在实验室管理方面,国家认监委负责对全国实验室和检查机构进行资质认定,目前已经对2.6万多家的实验室进行了资质认定;国家认监委授权的中国实验室认可机构(CNAS),已经对4000多家实验室进行认可。
In this connection, I wish to make a brief introduction to the role of CNCA. In 2001, CNCA was created with the approval of the State Council, which granted CNCA the mandate to exercise uniform management, oversight and across-the-board coordination in the area of certification and accreditation across the country. When it comes to lab management, CNCA is in charge of certifying the qualifications of labs and inspection bodies nationwide. Currently, CNCA has certified the qualifications of 26,000-plus labs. With CNCA’s authorization, CNAS, which is China’s lab accreditation body, has accredited 4,000-odd labs.
这些获得资质认定和实验室认可的检测机构从事的检测领域遍布各个产业,隶属于很多行业部门,包括在座的农业部门、环保部门、卫生部门和质检部门等。过去,我们只是对检测机构进行资质管理,从2008年以来,认监委致力于建立化学品良好实验室规范(GLP)的监控体系,目前已经发布了遵守OECD/GLP各项规则的GLP规范,检查了一些实验室,培训了一批检查员。认监委积极跟踪参与OECD/GLP的各项活动,连续三年都派遣代表作为观察员参加了OECD/GLP工作组年会,还曾经拜访了新加坡、南非的GLP监控机构,拜访过欧盟许多成员国的GLP实验室,积累了一定的GLP经验。
These inspection bodies that have acquired qualifications certification and lab accreditation conduct inspection across a wide variety of industries, which are under the jurisdiction of numerous sector-specific competent authorities, including the agencies some of you represent, i.e., the Ministry of Agriculture, the Ministry of Environmental Protection, the Ministry of Health and AQSIQ. In the past, our work was confined to the qualifications of inspection of bodies. Since 2008, CNCA has been dedicated itself to the creation of a GLP compliance monitoring program for chemicals. To date, CNCA has issued GLP guidelines that are compliant with OECD/GLP principles. Some labs have been inspected. Some inspectors have received training. CNCA has been following and participating vigorously in various OECD/GLP activities. For 3 years running, CNCA’s representatives have taken part in as observers the annual sessions of the OECD Working Group on GLP. CNCA’s delegations called upon the GLP monitoring authorities in Singapore and South Africa. We have visited GLP labs in many EU members. As a result, we have amass some experience in the GLP arena.
本次研讨会,也是认监委在今年OECD/GLP工作组会议上向GLP工作组秘书处正式提出来的请求,并在OECD/GLP秘书处的大力支持下才得以举行的。我们很感激OECD环境、健康与安全署、OECD/GLP工作组秘书处对中国的关注和支持。
At this year’s annual session of the OECD/GLP Working Group, CNCA made a formal request for a seminar to the Secretariat of the GLP Working Group. The current seminar would not take place without robust support from the OECD/GLP Secretariat. We are much grateful to OECD’s Environment, Health and Safety Division, the Secretariat of the OECD/GLP Working Group for their interest in and support for China.
中国是一个发展中大国,我们对GLP体系有着浓厚的兴趣,但同时对这套体系还存在很多认识上的不足,在检查员的培养上还需加大力度。我希望这次研讨会,以及下午即将开班的检查员培训,能够成为中国GLP事业的一个新的起点,能够成为各位见证中国GLP事业发展的一个里程碑。
China is a large developing nation. We have immense interest in the GLP system. Yet we continue to have an insufficient understanding of the system. We still need to do more to nurture inspectors. It is my hope that the current seminar and the inspectors training course, which is due to get underway this afternoon, will become a starting point in China’s GLP cause and a new milestone you will witness in this undertaking.
在此,再次感谢OECD对中国的关注和支持,感谢各位专家不远万里来华为我们培训检查员,是你们的努力与付出,才使我们这次研讨会顺利召开,才使中国的GLP体系又有了一个新的发展机遇。另外,也感谢商务部对GLP工作一直以来给予的指导,我们会在商务部的统一协调下,与环保部、农业部、卫生部食药监局、质检总局等部门一起,共同推动我国GLP体系的建设和国际合作,我相信,中国的GLP事业,会在诸位的共同努力下,走向一个更加美好的明天。
On this occasion, I wish to thank OECD again for its interest in and support for China. My thanks also go the specialists who have come to China to help train our inspectors by making light of traveling from afar. It is your effort and contribution that have made the current seminar possible. You present a fresh opportunity for the development of China’s GLP program. In addition, I’d like to thank the Ministry of Commerce for its long-standing guidance over the GLP work. Under the uniform of coordination by MOFCOM, we will strive to move forward the development of the GLP program in the country and international cooperation by joining forces with the Ministry of Environmental Protection, the Ministry of Agriculture, SFDA under the Ministry of Health and AQSIQ. We will create a better tomorrow with the concerted efforts from you.
最后,祝研讨会圆满成功!也预祝培训圆满成功!
Finally, may the seminar be a full success! I also wish in advance a full success for the training course!
谢谢。Thank you for your attention!

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