International Conference on Harmonisation; draft guidance on specifications: test procedures and acceptance criteria for biotechnological/biological products--FDA. Notice

The Food and Drug Administration (FDA) is publishing a draft guidance entitled "Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products". The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides guidance on general principles for the selection of test procedures and the setting and justification of acceptance criteria for biotechnological and biological products. The draft guidance is intended to assist in the establishment of a uniform set of international specifications for biotechnological and biological products to support new marketing applications.     

International Conference on Harmonisation; draft guidance on E2F Development Safety Update Report; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "E2F Development Safety Update Report." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes the format, content, and timing of a development safety update report (DSUR) for an investigational drug. The DSUR would serve as a harmonized, annual clinical trial safety report that would be standard among the three ICH regions. The DSUR could be submitted in the United States in place of an annual report for an investigational new drug application (IND). The harmonized DSUR is intended to promote a consistent approach to annual clinical safety reporting among the ICH regions and enhance efficiency by reducing the number of reports generated for submission to the regulatory authorities.     

从国际法角度看我国物权法草案中的征收补偿标准

征收及补偿问题不仅是物权法中的一个重要问题,也是一个国际法问题。我国物权法在规定征收及补偿问题时,须考虑国际社会的通常做法和我国政府对其他国家已做出的承诺。在征收补偿方面存在着国际法规则。投资协定的约束是确定的,而国际习惯法的约束则取决于各国的取舍。我国现行法律实质上未能明确征收补偿标准,而我国对外签署的投资协定则接受了“充分补偿”标准。物权法(草案)中的“合理补偿”标准并不合理。建议物权法在规定征收补偿标准时,以“充分补偿”为原则,以“另依特别规定”为补充。     

节目还是信号?——广播组织权客体探惑

对于广播组织权的客体问题,学界始终在"信号"与"节目"间争论不休.在《著作权法》第三次修订过程中,广播组织权的客体也经历了从一审稿中"载有节目的 信号"到二审稿及最终生效稿"广播、电视"的过程.尽管《著作权法》第三次修订已经完成,但重新审视学界关于"信号说"与"节目说"的观点,对于理解广播组织权客体仍有必要.从历史分析的角度出发探究广播组织权的设立初衷,结合学界对广播组织权客体"节目说"与"信号说"两种观点,在体系解释框架下对广播组织权制度的走向进行展望,以保证法律条款之间的融贯.     

从MAI看综合性国际投资多边立法的困境和出路

经合组织（ＯＥＣＤ）在１９９５年到１９９８年起草的多边投资协定（ＭＡＩ）草案,是一个高度自由化性质的多边投资条约草案,集中反映了西方国家关于自由化性质的国际投资多边立法的种种要求,也表露出ＭＡＩ谈判方之间的种种矛盾和冲突,这些情况值得引起发展中国家的高度关注。ＯＥＣＤ的ＭＡＩ计划的搁浅,不仅说明发达国家对于何谓可接受的自由化多边投资规则尚不能形成一致的意见,也预示了未来综合性多边投资条约谈判应遵循的基本法则,即能够为各国广泛接受的综合性多边投资条约,必须同时反映不同国家的利益需求,谋求国家间利益的适当平衡。只有沿着建立新的国际经济秩序的方向前进,国际社会才有可能确立一个具有普遍效力的综合性、全球性多边投资条约。     

论侵权责任法草案二次审议稿的侵权行为一般条款

《侵权责任法》如何规定侵权行为一般条款,是极为重要的问题。我国《侵权责任法草案》对此曾经做了不同的规定,至二次审议稿提出了一个较为独特的文本,即第2条"侵害民事权益,应当承担侵权责任。"这个与众不同的侵权行为一般条款,实际上采纳的是最新的侵权行为一般条款的立法模式,但存在一些缺点。在作出改进后,可以作为具有中国特色的侵权责任法的核心条款,起到统帅全文的作用。     

Draft guidance for industry on developing medical imaging drugs and biologics; availability--FDA. Availability of guidance

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Developing Medical Imaging Drugs and Biologics." This draft guidance is intended to assist developers of drug and biological products used for medical imaging, as well as radiopharmaceutical drugs used in disease diagnosis, in planning and coordinating the clinical investigations of, and submitting various types of applications for, such products. The draft guidance also provides information on how the agency will interpret and apply provisions in the proposed regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring, which published in the Federal Register of May 22, 1998 (63 FR 28301).     

Universal Jurisdiction Meets Complementarity: An Approach towards a Desirable Future Codification of Horizontal Complementarity between the Member States of the International Criminal Court

This paper will propose a first draft provision concerning horizontal complementarity between the member states of the ICC. Firstly, the idea of subsidiary universal jurisdiction will be introduced. At its heart, the work will bring the concepts of vertical complementarity and subsidiary universal jurisdiction into relation to define a desirable future codification of horizontal complementarity. The author will focus on the following seven issues that have to be addressed during the drafting of such codification: The relationship between the actors; the legal qualification of horizontal complementarity; the underlying idea and ratio behind the concept; a positive or negative determination of complementarity; the definition of horizontal complementarity; the question who the final arbiter of a determination should be; the matter of compliance with decisions. It will be seen that Art 17 ICC Statute can serve as a useful basis of this codification but that the special relationships on the inter-state level will inevitably lead to some deviating requirements of this principle.     

Draft guidance for industry; exports and imports under the FDA Export Reform and Enhancement Act of 1996--FDA. Notice

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled, "FDA Draft Guidance for Industry on: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996." The draft guidance document addresses issues pertaining to the exportation of human drugs, animal drugs, biologics, food additives, and devices as well as the importation of components, parts, accessories, or other articles for incorporation or further processing into articles intended for export.     

民法典草案的基本结构——以民法的调整对象理论为中心

本文探讨了大陆系主要国家民法典的理论渊源。作者认为 ,德国民法典创立的潘得克吞体的总则部分掩盖了“人法”的价值。作者提出的我国民法典基本结构包括人身关系法和财产关系法两大部分。在此基础上 ,作者还对我国民法典的若干基本制度提出了框架性意见     

Medical device warning letter draft pilot; availability--FDA. Notice

The Food and Drug Administration (FDA) is planning to initiate a pilot program involving the medical device industry that is a continuation of the "medical device industry initiatives." This draft pilot concerns the issuance of warning letters for quality system, premarket notification submission (510(k)), and labeling violations. This draft pilot is intended to optimize resource utilization, enhance communication between industry and FDA, and provide firms with incentives to promptly correct violations or deficiencies. The draft pilot includes eligibility criteria and procedures for the issuance of warning letters and will not be implemented until after the public comment period has expired.     

Draft guidance for industry; container and closure integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products; availability--FDA. Notice

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Guidance for Industry: Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products." The draft guidance is intended to provide recommendations and offer alternative methods for sterility testing to confirm the integrity of container and closure systems for sterile biological products, human and veterinary drugs, and medical devices. The draft guidance applies only to the replacement of the sterility test with an appropriate container and closure integrity test in the stability protocol, and it is not offered as a replacement for sterility testing for product release.     

关于起草我国国际私法法典的几点想法

国际私法带有“学说法”的特点，这主要是因它不是实体法，而是法律选择法——“间接法”所决定的。涉外民事法律适用总的指导原则的设立与实施始终是国际私法学中未解决的问题。在清点和检查我国已有法律适用法规定的基础上，进行新草案的起草、说明和论证显得尤为必要。     

抓住机遇 迎接挑战 谋求发展——《刑诉法修正案（草案）》关于鉴定结论等问题的新变化

《刑事诉讼法修正案（草案）》将于2012年3月提交全国人大审议通过。其中对鉴定结论作了科学定位,对鉴定人出庭作证及拒不出庭的法律后果作出了有别于普通证人的明确规定。这是由鉴定证据的特殊性和鉴定人的特殊身份所决定的。这对司法鉴定机构及从业人员既是挑战,又是机遇;应当抓住机遇,迎接挑战,谋求发展。     

The UN and Corporate Environmental Responsibility: Between International Regulation and Partnerships

This article analyses the successive attempts of the United Nations to ensure the responsible conduct of transnational corporations, and of business in general, with reference to the protection of the environment. The article will concentrate mainly on the UN draft Code of Conduct for Transnational Corporations, the 'partnership with business' approach of the Global Compact and the human-rights-based approach of the Norms on the Responsibilities of Transnational Corporations and Other Business Enterprises with regards to Human Rights. After considering recent developments at the UN Commission on Human Rights, the article evaluates the continued efforts, diverse strategies and multi-faceted institutional role of the UN in keeping the issue of corporate environmental responsibility on the international agenda and in trying to identify the international environmental standards directly applicable to business entities.     

Results of the Discussion of the Draft Code of Civil Procedure of the RSFSR

In publishing the major provisions of the draft Code of Civil Procedure of the RSFSR, the editors of Sovetskaia iustitsiia wished to organize a broad exchange of opinions among readers on the most fundamental and controversial problems of Soviet civil procedure. Articles appearing in the press, the speeches at the All-Union Conference to Discuss the Drafts of the RSFSR Civil and Civil Procedure Codes, and the numerous letters received by the editors of this journal and by the Ministry of Justice of the RSFSR bear witness to the broad nature of the discussion. Along with the generally positive evaluation of the draft, the participants in the discussion voiced a number of critical observations and proposals aimed at improving it. Although we cannot deal with all the questions touched upon in the course of the discussion, we shall note the most fundamental of them in the sequence in which their content is dealt with in the draft code.     

The legal and ethical aspects of medical malpractice in Turkey

The issue of patients' rights is relatively unknown in our country but it is often recalled when an incident of death or disability is suspected as being caused by a physician's error. However patients' rights are being violated thousands of times every day in our country. More than these patients' rights' violations, the essential point is the lack of a mechanism to claim those rights and to complain about the practices which violate them. In our country, patients and their relatives are uninformed, powerless and unprotected against physicians and health organizations, and they typically accept whatever happens to them without complaint. Some of the reasons for this are, presumably, an underdeveloped consciousness of patients' rights, an absence of patient organizations, and insufficient ethical and legal regulations on patients' rights. These deficiencies were diminished somewhat by the "Regulation on Patients' Rights," which was prepared by the Ministry of Health in 1998. Another legal draft law referred to as "Responsibilities Due to Malpractice in Medical Services" has been prepared and is in the process of becoming law. This draft law and the general conditions of the country on this subject are evaluated in this article.     

Chest x-ray referral criteria panel draft report; availability--Food and Drug Administration

The Food and Drug Administration (FDA) announces the availability of a draft report. "Chest X-Ray Referral Criteria Panel Draft Report No. 1: Selected Screening Uses of the Chest X-Ray Examination" developed by a panel of physicians on the utility of selected chest x-ray screening examinations. This notice also describes FDA's planned procedures to facilitate the development and testing of referral criteria for medical radiological examinations.     

我国上市公司委托书征集立法研究

我国现行有关委托书征集的立法主要是委托授权的内容 ,对于征集行为还没有明确、详细的规范。随着我国上市公司股权结构的日趋多元化 ,委托书征集(包括委托书争夺 )现象将会不断发生。证券监管部门应在考察我国资本市场现状和今后发展趋势的基础上 ,借鉴其他国家相关立法 ,尽快制定有关委托书征集规则。     

“商法通则”三大基本制度研究

目前,法学界对于"商法通则"的制定问题已经展开了讨论,但是,其中大部分的研究还只是停留在诸如是否要制定"商法通则",以及:"商法通则"的基本框架结构的层面上,而较少涉及"商法通则"所应规范的基本制度的研究.在"商法通则"所应规范的基本制度方面谈一些自己的意见,仅供立法者和研究者参考.