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| USP各論示例 |
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| 修訂類型 | Erratum/Errata（勘誤） |
| 修訂符號和文本標注 |
 (ERR 1-Feb-2019) |
| USP官方釋義1 | Errata are Accelerated Revisions representing corrections to items erroneously published. |
| 譯文：勘誤是按加速修訂程序，對錯誤發(fā)布的項目進行的更正。 | |
| USP官方釋義2 | Errata published in the errata table are errors, clarifications, or missing information such as inaccuracies in chemical formulas, mathematical equations relevant to analyses and/or inaccurate descriptions of the apparatus, or materials used to perform analytical tests. Typically Errata are changes that do not have a broad impact on the standard. Errata are not subject to public notice and comment. |
| 譯文：勘誤表中公布的勘誤是錯誤、澄清或遺漏的信息，如與分析有關(guān)的化學公式、數(shù)學公式不準確和/或?qū)τ糜谶M行分析測試的儀器或材料的描述不準確?？闭`表通常是對標準沒有廣泛影響的更改?？闭`表無需公示和征求意見。 | |
| USP官方釋義3 | Errata refer to an accelerated revision vehicle used to correct published content in a USP compendium that does not accurately reflect the intended requirements of a standard as approved by the responsible Expert Committee. Errata published on the USP webpage most often become official/effective on the first day of the month following publication; however, in some cases the official date of the Errata may be extended to align with previously published revisions that have not yet become official. The official or effective date will be noted in the revised version of these standards as well as in the revision tagging associated with the specific Errata. |
| 譯文：勘誤指的是一種加速修訂工具，用于糾正USP中未準確反映主管專家委員會批準的標準預期要求的已出版內(nèi)容。USP網(wǎng)頁上公布的勘誤表通常在公布后當月的第一天正式生效；但在某些情況下，勘誤的正式生效日期可能會延長，以便與之前公布的尚未正式生效的修訂版保持一致。正式或生效日期將在這些標準的修訂版以及與具體勘誤相關(guān)的修訂標記中注明。 | |
| 勘誤表公布網(wǎng)址 | https://www.uspnf.com/official-text/errata-table |
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| 注：可在搜索框中輸入關(guān)鍵詞進行檢索。 |
| USP各論示例 |
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| 修訂類型 | Interim Revision Announcement（臨時修訂聲明） |
| 修訂符號和文本標注 |
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| USP官方釋義1 | IRAs are an expedited mechanism for making revisions official. An IRA appears in PF first as a Proposed Interim Revision Announcement with a 90-day comment period. If there are no significant adverse comments, the IRA becomes official and is immediately incorporated into the USP-NF with the official date indicated. |
| 譯文：臨時修訂聲明是一種使修訂生效的快速機制。IRA首先作為“擬議臨時修訂聲明”出現(xiàn)發(fā)布在PF上，有90天的征求意見期。如果沒有重大的反對意見，IRA將在公示結(jié)束后立即成為正式版本，并立即納入USP-NF并注明正式日期。 | |
| USP官方釋義2 | IRAs are used: (1) to correct substantive errors (beyond the scope of Errata); (2) to address non-urgent patient safety or compliance issues where public comment on the revision is warranted; (3) to address time-sensitive reference standard (RS) issues, including but not limited to changes in a form or a presentation of an RS; and (4) to correct non-working tests in a standard. |
| 譯文：IRA用于：(1) 糾正實質(zhì)性錯誤（超出勘誤表范圍）；(2) 解決非緊急的患者安全或合規(guī)性問題，在此情況下，公眾有必要對修訂提出意見；(3) 解決具有時效性的標準品/對照品（RS）問題，包括但不限于更改RS的形式或表述方式；(4) 糾正標準中的非工作檢測。 | |
| IRA正式文本發(fā)布網(wǎng)址 |
https://www.uspnf.com/official-text/iras
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| USP各論示例 |
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| 修訂類型 | Revision Bulletin（修訂公告） |
| 修訂符號和文本標注 |
 (RB 1-May-2018) |
| USP官方釋義1 | Revision Bulletins are Accelerated Revisions to official text or postponements that require expedited publication. They generally are official immediately unless otherwise specified in the Revision Bulletin. |
| 譯文：修訂公告是對正式文本的加速修訂或需要快速發(fā)布的延期公告。除非《修訂公告》中另有說明，否則它們通常立即成為正式文本。 | |
| USP官方釋義2 | Revision Bulletins are used to address issues that require rapid publication of official text, namely: (1) to correct substantive errors (beyond the scope of Errata); (2) to address urgent patient safety issues; (3) to address compliance issues where public comment is not warranted; (4) to issue postponements in response to Requests for Postponement (see Rules); (5) to remove postponed text from the official text of the compendium when the postponement has not been resolved within the normal revision lifecycle; and (6) to effectuate appeals-related revisions (see Rules). |
| 譯文：修訂公告用于解決需要快速發(fā)布正式文本的問題，包括：(1) 糾正實質(zhì)性錯誤（超出勘誤表范圍）；(2) 解決緊急的患者安全問題；(3) 解決無需征求公眾意見的合規(guī)性問題；(4) 根據(jù)延期請求發(fā)布延期公告；(5) 當延期問題未能在正常修訂周期內(nèi)解決時，從藥典正式文本中刪除延期文本；(6) 實施與申訴有關(guān)的修訂。 | |
| USP官方釋義3 | Revision Bulletins are most often official on the first day of the month that follows the month in which they are published. However, in some cases the official date of the Revision Bulletin may be extended to align with previously published revisions that have not yet become official. The official date will be noted in the revised version of these standards as well as in the revision tagging associated with the specific Revision Bulletin. |
| 譯文：修訂公告通常在發(fā)布當月的下一個月第一天正式生效。不過，在某些情況下，修訂公告的正式日期可能會延長，以便與之前發(fā)布但尚未正式生效的修訂版本保持一致。正式日期將在這些標準的修訂版本以及與特定修訂公告相關(guān)的修訂標記中注明。 | |
| RB正式文本發(fā)布網(wǎng)址 |
https://www.uspnf.com/off icial-text/revision-bulletins |
| USP各論示例1 |
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| USP各論示例2 |
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| 修訂類型 | Compendial Notice（藥典通知） |
| • Chapter Reference（通則引用） | |
| 修訂符號和文本標注 |
 (CN 1-May-2020) |
 (Official 1-Jan-2018) |
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| USP官方釋義1 | Compendial Notice revisions are used sparingly to update, edit, or correct issues in compendial text that do not fit any of the categories described above, but where expeditious revision serves public health and quality needs and where public comment is not warranted. |
| 譯文：藥典通知修訂很少用于更新、編輯或糾正藥典文本中不符合上述任何類別的問題，但適用于快速修訂可滿足公眾健康和質(zhì)量需求且無需征求公眾意見的情況。 | |
| USP官方釋義2 | Reference Changes represent an example of changes made via Compendial Notice. Sometimes it is necessary for USP to modify general chapter titles, section titles, appendix titles, reference to external resources, or similar text that may be referenced in standards throughout the USP–NF. Any reference changes that will have an impact on the interpretation or requirements of the standard are made using the routine revision process including publication for comment in PF. In cases in which an update appears to present no significant change in the affected standard, they are implemented through a direct update of the reference in that standard without providing an opportunity for notice and comment. In these cases, USP will publish on its webpage a Compendial Notice (CN) indicating the source change and any resulting references. Updates made through direct publication in the USP–NF will be clearly identified by symbols and shading. |
| 譯文：參考或引用更改是一種通過藥典通知進行的變更。有時，USP有必要修改通則大標題、章節(jié)標題、附錄標題、外部資源引用或可能在USP-NF各標準中引用的類似文本。任何會對標準的解釋或要求產(chǎn)生影響的參考或引用變更，都是通過常規(guī)修訂程序進行的，包括在PF中公布征求意見。如果更新似乎不會對受影響的標準造成顯著改變，則通過直接更新該標準中的參考或引用來實施，而不再通知和征求意見。在這些情況下，USP將在其網(wǎng)頁上發(fā)布藥典通知 (CN)，說明來源更改和任何由此產(chǎn)生的參考或引用。在USP-NF中直接發(fā)布的更新將通過符號和陰影清楚地標識。 | |
| USP官方釋義3 | Because some updates to references may be assigned delayed official dates to ensure that all related revisions become official together, the revision markup used to identify the reference updates will be dependent upon when the change will become official. Updates becoming official at the same time as the USP–NF vehicle in which they are published will be identified with the following revision markup, where CN denotes Compendial Notice: |
| • Changed text ▲ (CN 1-May-2019) | |
| Updates becoming official/effective with a greater than 6-month implementation period will be identified with the following revision markup: | |
| • Changed text ▲ (Official 1-May-2019) | |
| 譯文：由于某些參考或引用來源的更新可能會被指定延遲的正式日期，以確保所有相關(guān)修訂都能一起成為正式版本，因此用于標識參考資料更新的修訂標記將取決于更改何時成為正式版本。 | |
| 與USP-NF版本同時成為正式版本的更新將使用以下修訂標記來標識，其中CN表示藥典通知： | |
| • 更改后的文本 ▲ (CN 1-May-2019) | |
| 正式生效/實施期超過6個月的更新將使用以下修訂標記進行標識： | |
| • 更改后的文本 ▲ (Official 1-May-2019) | |
| 藥典通知更新網(wǎng)址 |
https://www.uspnf.com/notices/new
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| USP各論示例 |
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| 修訂類型 | Harmonization（協(xié)調(diào)） |
| 修訂符號和文本標注 |
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| USP官方釋義1 | USP harmonizes pharmacopeial excipient monographs and general chapters through the Pharmacopeial Discussion Group (PDG), which includes representatives from the European, Japanese, and United States pharmacopeias and WHO (as an observer). According to the PDG definition, "a pharmacopeial general chapter or other pharmacopeial document is harmonized when a pharmaceutical substance or product tested by the document's harmonized procedure yields the same results and the same accept/reject decision is reached." |
| 譯文：USP通過藥典討論組 (PDG) 協(xié)調(diào)藥典輔料各論和通則，該討論組包括來自歐洲藥典、日本藥典和美國藥典以及WHO（作為觀察員）的代表。根據(jù)藥典討論組的定義，“當藥用物質(zhì)或產(chǎn)品通過該文件的協(xié)調(diào)程序測試得出相同的結(jié)果，并做出相同的接受/拒絕決定時，該藥典通則或其他藥典文件即被協(xié)調(diào)”。 | |
| USP官方釋義2 | The specific stages of the PDG Procedure (Process) involved in Harmonization are: |
| Pre-PDG | |
| Stage 1: Preparation of first draft | |
| Stage 2: Official Inquiry | |
| Stage 3: Consensus | |
| Stage 4: Regional adoption and implementation | |
| Stage 5. Inter-regional acceptance (for chapters previously evaluated by ICH Q4B for Regulatory Interchangeability) | |
| 譯文：協(xié)調(diào)工作所涉及的 PDG 程序（過程）的具體階段包括 | |
| PDG 前期 | |
| 第 1 階段：編寫初稿 | |
| 第 2 階段：正式調(diào)研（征求意見） | |
| 第 3 階段：協(xié)商一致 | |
| 第 4 階段：地區(qū)通過和實施 | |
| 第 5 階段：區(qū)域間接受（適用于之前經(jīng) ICH Q4B 評估為監(jiān)管互換性的章節(jié)） | |
| 階段4通知公布網(wǎng)址 |
https://www.usp.org/harmonization-standards/pdg/stage-4-notices
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| Revision Type | Revision Symbol and Text |
| 修訂類型 | 修訂符號和文本 |
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In Process Revision (Book or Supplement) 正在修訂（正式或增補） |
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| Interim Revision Announcement | (IRA 1-Jul-2020) |
| 臨時修訂聲明 | |
| Revision Bulletin |
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| 修訂公告 | |
| Harmonization |
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| 協(xié)調(diào)（ICH） | |
| Errata |
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| 勘誤 | |
| Chapter References |
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| 通則引用 | (Official 1-Jul-2020) |
| Pending |
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| 待定 |
來源：注冊圈
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