201801 TGA處方葯可比性境外葯監機構標準、基於COR報告的審評程序和工作分擔

TGA

Comparable overseas regulators (CORs) for prescription medicines

處方葯可比性境外葯監機構（COR）

Criteria, COR report-based process and work- sharing

標準、基於COR報告的程序和工作分擔

201801 版本1.0

TGA makes use of assessments from comparable overseas regulators (CORs), where possible, in the regulation of prescription medicines.

TGA在可能的情況下會使用可比性境外葯監機構（COR）的審評進行處方葯管理。

In response to the Medicines and Medical Devices Review (MMDR) we are reforming the way we collaborate with comparable overseas regulators.

為響應藥品和醫療器械審評（MMDR），我們正在重組與可比性境外葯監機構的合作方式。

This includes:

這包括：

?development of transparent criteria for identifying CORs

?識別COR的透明標準的發展

?opportunities forcollaboration

?協作機會

?a process for use of overseas reports and work-sharing

?使用境外報告和工作分擔的程序

Criteria for identifying CORs識別COR的標準

These criteria help identify opportunities for enhanced international collaboration in the regulation of prescription medicines.

這些標準有助於識別增加處方葯法規方面國際協作的機會。

These criteria apply for both thework-sharing and COR report-based processes.

這些標準適用於工作分擔和基於COR報告的程序。

The COR criteria are applied in two stages:

COR標準在2個階段適用：

?Stage 1: The first stagesets out the preliminary criteria that confirm that there is sufficient similarity between TGA and the overseas agency to support collaborative work;either TGA』s use of an existing, complete assessment report or a work-sharing proposal.

?第1階段：第1階段設置了確認TGA與境外葯監機構具有足夠的相似度來支持協作工作的基本標準，可以是TGA使用現有的完整審評報告，也可以是工作分擔提議。

?Stage 2: The second stage outlines the parameters that are relevant to a particular submission.These would be considered at the time a submission is made to TGA that proposes either a work-sharing arrangement or reliance on COR assessment reports insteadof de novo evaluation. These criteria can also inform first stage considerations.

?第2階段：第2階段列出了與特定申報資料相關的參數。這將在向TGA提交申報資料提議工作分擔安排或依賴於COR審評報告，而不是從頭評估時納入考量。這些標準也可以納入第2階段考量。

These criteria have been applied to generate an initial list of overseas agencies for the COR report-based process.

這些標準已經應用於生成基於COR報告程序的首個境外葯監機構清單。

Stage1 criteria第1階段標準

The first stage sets out the preliminary criteria that confirm that there is sufficient similarity between the overseas agency and us to support collaborative work of this nature.

第1階段設定了確認境外葯監機構與我們具有足夠的相似度以支持此種協作的基本標準。

Criterion1標準1

The COR』s regulatory framework should besimilar to that of TGA in terms of what must and must not be taken into accountin making regulatory decisions.

在註冊決策時哪些必須考慮哪些不得考慮方面，該COR的註冊框架應與TGA相似。

To meet this criterion the COR would need to:

為符合此標準，該COR需要：

?conduct similar pre- and post-market regulatory activities, including

?實施類似的上市前和上市後法規活動，包括

–Good Manufacturing Practice inspections programs

–優良生產規範檢查程序

–pharmacovigilance programs

–藥物警戒程序

–full de novo assessments (safety, quality and efficacy) of the type of applications that are of interest to us (e.g. assessments of new chemical or biological entities, genericmedicines, biosimilars and subsequent variations to these goods)

–對我們有益（例如，新化學或生物實體審評、仿製葯、生物類似物和這些產品的後續變更）的申報類型的全面完整審評（安全、質量和有效性）

?have a transparent system for regulating therapeutic goods, including its assessment processes and legal accountability (conflict of interest processes).

?具備規範治療產品的透明系統，包括其審評流程和法律可信度（利益衝突程序）

Criterion2標準2

TGA must have established a formal and robust framework for cooperation with the COR.

TGA必須與該COR建立正式穩定的協作框架。

To meet this criterion the COR would need to have an agreed Memorandum of Understanding (MOU) or exchange of letters with the TGA that allows clear, open, secure communication on regulatory issues and transmission of confidential information.

為符合此標準，該COR需要與TGA簽署有諒解備忘（MOU）或互換函件，使得雙方在法規事務和保密信息傳送方面達成清晰、公開和安全的溝通。

Criterion3標準3

The COR must use international guidelines and standards consistent with those adopted by the TGA.

該COR所使用的國際指南和標準必須與TGA所採納的一致。

To meet this criterion the COR would needto have established scientific evaluation processes in accordance with The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and other international guidelines, as well as pharmacopoeial standards adopted by Australia (the European Pharmacopoeia, British Pharmacopoeia and United States Pharmacopeia).

為符合此標準，該COR需要建立科學評估流程，符合ICH和其它國際指南，以及澳大利亞採納的藥典標準（EP、BP和USP）。

To best make use of overseas assessments, any differences in how these international standards are adopted will need to be well understood.

為最大程度使用境外審評，要很好了解所採納的國際標準之間的所有差異。

Criterion4標準4

The COR should be able to conduct their business and release reports in English.

該COR應可以採用英語執行其業務以及發行報告。

?For the COR report-basedprocess, the applicant must have access to the assessment reports in English for inclusion in the Australian application (this can include reports that have been translated into English from another language by the COR).

?在基於COR報告的程序中，申報人必須可獲得英文審評報告以放進澳大利亞申報資料中（也可以放入COR從另一種語言翻譯成英語的報告）。

?For work-sharing, it is important that our evaluators are able to communicate in English with those who conduct the assessments.

?如果是工作分擔，很重要的一點是我們的評審員應有能力使用英語與執行審評的人溝通。

Stage2 criteria第2階段標準

Stage 2 criteria focus on the specifics of a particular application. Once an overseas regulator has been identified as either a source of assessment reports or a work-sharing partner, the following considerations will be applied to determine whether the proposed use of COR reports or work- sharing can proceed.

第2階段標準關注的是特殊申報方面。一旦一個境外葯監機構被識別為審評報告的來源或工作分擔夥伴，則以下考量將被用於確定是否可使用COR報告或可以進行工作分擔。

Criterion5標準5

Equivalent indications are proposed for the medicines (including dosage regimen and route of administration).

藥品擬定等同的適應症（包括給藥方案和給葯途徑）。

To meet this criterion:

為符合此標準：

?the proposed indicationfor the medicine would need to be based on broadly similar population demographics, disease profiles, and expectations regarding public health outcomes between Australia and the COR

?藥品的所擬適應症需要基於澳大利亞與COR之間更廣泛的相似人群特徵、疾病概況和公眾健康結果預期。

?any differences wouldneed to be identified and justified by the applicant

?任何差異均需申報人進行識別和論證

Criterion6標準6

The medicine for which Australian registration is sought is identical to that approved by, or submitted to, the COR (i.e. dosage form, strength, formulation and manufacture).

澳大利亞註冊的藥品與該COR批准或向其提交的藥品是完全一樣的（即，劑型、劑量、處方和生產）。

To meet this criterion, the assessment reports must relate to the same medicine (identical in terms of quality aspects of the product).

為符合此標準，審評報告必須是針對相同的藥品（藥品質量方面完全相同）。

?For the COR reportprocess, the manufacturing process must be identical to that assessed by the COR but additional manufacturing sites can be included in the application to the TGA (under certain conditions).

?在基於COR報告的審評流程中，生產工藝必須與由該COR審評的完全相同，但在提交給TGA的申報資料中可以包括其它的生產場所。

?For work-sharing, this includes identical manufacturing sites and process.

?在工作分擔中，應為完全相同的生產場所和工藝。

Criterion7標準7

Assessment reports should be prepared using guidelines and standards consistent with those used by the TGA.

審評報告起草所用指南和標準應與TGA所用一致。

To meet this criterion, the assessment reports should be prepared in the Common Technical Document (CTD) format and consistent with a methodology used by the TGA. A key consideration is whether the assessment reports have the required scope. For example, in the case of clinical assessments, we would consider what studies and analyses have been included, and for each of these, the data cut-off for analysis.

為符合此標準，審評報告應以CTD格式起草，與TGA所用方法學一致。一個關鍵的考量是該審評報告是否針對所需的範圍。例如，在臨床審評案例中，我們會考虎包括什麼研究和分析，每個研究和分析的數據取捨。

Differences in methodology need not prevent the use of the assessment reports. However, we would require additional information to address any gaps or concerns, reducing the benefit of using an overseas report.

方法學差異不一定會妨礙審評報告的使用。但是，我們會要求額外的資料來解決所有的差距或問題，這會減少使用境外報告的優勢。

Criterion8標準8

Assessment reports must be un-redacted and complete.

審評報告不得塗抹遮蓋，必須完整。

To meet this criterion, the complete reports should include correspondence related to the application (e.g.questions asked of, and deliberations by, advisory bodies).

為符合此標準，完整報告應包括與申報有關的通信（例如，顧問方所問的問題和完整討論情況）

?For the COR report-based process, the Australian applicant is responsible for providing the reports tous when lodging the application.

?在基於COR報告的程序中，澳大利亞申報人有義務在編製申報時向我們提交這些報告

?For work-sharing, the reports will be provided by the COR.

?如果是工作分擔，則這些報告將由COR提供

Criterion9標準9

The TGA should be able to use assessment reports and any supplementary information generated during the evaluation process as part of Australian Public Assessment Reports (AusPARs).

TGA應可使用評審報告和任何在評估過程中生成的補充資料作為澳大利亞公開審評報告的一部分。

To meet this criterion, reports that areprovided to us should not be subject to any restrictions on use or disclosure by TGA other than those which would apply to any material provided in anapplication dossier (e.g. these reports must be able to be used as the basis for published AusPARs).

為符合此標準，提供給我們的報告不能有任何使用限制或TGA公開限制，申報文檔中所提交的適用物料的報告除外（例如，這些報告必須可以用作公開發布的AusPARs的一部分）。

Overseas regulator confidentiality provisions may also affect our ability to publish information generated through work-sharing arrangements in AusPARs. In considering a work-sharing application, we will therefore be informed by the formal relationship established with the overseas source regulator, specifically in relation to confidentiality provisions.

境外葯監機構保密條款可能也會影響我們在AusPAR中公開通過工作分擔所生成的信息。在考慮分作分擔申報時，我們會通過與境外源機構所建立的正式關係收到通知，尤其是與保密條款有關的情況。

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