美國藥典的管理、標準制定和顧問機構(gòu)

USP GOVERNANCE STANDARDS-SETTING, AND ADVISORY BODIES

USP's governing, standards-setting, and advisory bodies include the USP Convention, the Board of Trustees the Council of Experts and its Expert Committees, Advisory Panels, and staff. Additional volunteer bodies include Stakeholder Forums, Project Teams, and Advisory Groups, which act in an advisory capacity to provide input to USP's governing, standards-setting, and management bodies. 2

美國藥典的管理、標準制定和顧問機構(gòu)

美國藥典的管理、標準制定和顧問機構(gòu)包括:美國藥典大會、理事委員會、專家委員會和專家小組委員會、顧問小組以及員工。•其他志愿機構(gòu)包括:股東論壇、項目團隊、和顧問小組，他們以顧問身份給美藥典的管理、標準制定和經(jīng)營機構(gòu)提供信息或資金。

USP Convention — USP's direction and priorities are determined by more than 400 Convention members divided into nine categories. Eligible organizations within each membership category are invited to appoint a representative. Convention composition is determined to ensure suitable representation of those sections of the health care system that are influenced by, and in turn influence, USP's activities. Convention members elect USP's President, Treasurer and other members of the Board of Trustees as well as the Council of Experts. They also vote on resolutions to guide USP's scientific policy and public health initiatives and update, as needed, USP's Constitution and By-Laws.

美國藥典大會美國藥典的方針和重點由超過400位的藥典大會成員來決定，他們分為9個類別。下屬類別中符合條件的組織被邀請派一個代表。藥典大會的組成堅決保證衛(wèi)生保健體系中的這些部門適當?shù)拇硇裕@些部門受到藥典大會的影響，反過來也影響藥典大會的活動。藥典大會成員選舉USP總裁、財務(wù)主管、其他理事會和專家委員會的成員。他們也投票決定指導藥典的科學決策、公共衛(wèi)生措施，如果必要，也更新藥典的章程和內(nèi)部規(guī)章。

Board of Trustees — USP's Board of Trustees is entrusted with management of the business affairs, finances, and property of USP. During its five-year term, the Board defines USP's strategic direction through its key policy and operational decisions.

理事委員會藥典的理事委員會負責管理藥典的業(yè)務(wù)、金融和財產(chǎn)。在五年任期內(nèi)，管理委員會通過關(guān)鍵決策和可操作性明確美國藥典的策略方向。

Council of Experts — The Council of Experts is the standards-setting body of USP. It is composed of 57 Expert Committee Chairs elected to five-year terms by USP's Convention members. A Nominating Committee, consisting of the Chair of the Council of Experts, the Convention President, and the Vice Chair of the Nominating Committee for the Council of Experts, nominates individuals who are subsequently elected by the members of the Council of Experts to serve as Expert Committee members. Collectively, the Expert Committee Chairs and members comprise more than 500 volunteers drawn from 50 countries. The 41 Standards Expert Committees are responsible for the content of USP–NF, the Food Chemicals Codex and associated publications and organized in Collaborative Groups for topics of common interest. 專家委員會 專家委員會是美國藥典的標準制定機構(gòu)。由藥典大會選舉出的57名專家主任委員組成，任期五年。由專家委員會主任委員、藥典大會總裁以及提名專家委員會的提名委員會副主任委員構(gòu)成的提名委員會推薦候選人，然后由專家委員會選舉擔當專家委員會成員。專家委員會主任委員和成員包含從50個國家選擇成立500多個志愿者。41個標準專家委員會負責《美國藥典/國家處方集》、《食品化學物質(zhì)集》以及相關(guān)出版物的內(nèi)容，并成立多個協(xié)作小組討論共同關(guān)注的話題。

Advisory Panels to the Council of Experts— The Chair of the Council of Experts may appoint Advisory Panels to assist the Council of Experts in reaching scientific decisions and implementing new USP directives relating to USP–NF. The list of the Advisory Panels changes frequently as the work of Advisory Panels concludes and new ones start their deliberations. There are more than 350 Advisory Panel members who contribute to the standards-setting activities of the Council of Experts. 專家委員會顧問小紐專家委員會主任委員可以任命顧問小組幫助專家委員會做科學決定、實施有關(guān)《美國藥典/國家處方集》新方針。顧問小組名單隨著顧問小組工作的結(jié)束以及新的顧問小組的審議工作的開始而經(jīng)常改變。有超過350個顧問小組成員，他們?yōu)閷＜椅瘑T會制定標準作出了貢獻

Stakeholder Forums and Project Teams — USP has formed several domestic and international Stakeholder Forums and Project Teams in the 2005–2010 cycle to exchange information and receive comment on USP's standards-setting activities. Depending on the topic, a stakeholder forum may form project teams to work on selected topics. 股東論壇和項目小組美國藥典在2005?2010期間，在國內(nèi)外成立了幾個股東論壇和項目小組來交流信息，收集有關(guān)USP標準建立活動的評論。依據(jù)這些話題，股東論壇就可以成立項目小組研究有關(guān)話題。

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