澳洲保健食品登记法规问题集

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各国健康食品登记法规问题集

时间：2023/08/24 drafted by Yvonne Chen

HLF-TW-10
请问澳洲对于保健食品的归类方式为何？它的正式名称为何？不同归类管理强度有何差异?它的政府管辖机构为何？网页？

What are the categories of health food in Australia? What is its official name? What is the intensity of management of different categories? What is the governmental authority of health food? Website?
Evershine RD：
在澳洲，保建食品被称为补充药物，由治疗用品管理局 (TGA) 负责监管。当产品成分至少含有一种指定活性成分，则被视为补充药物。

指定活性成分：
1.氨基酸
2.木炭
3.胆硷盐
4.精油
5.植物或草药材料(或此类材料的合成替代品)
6.顺势疗法製剂
7.完整或萃取的微生物(疫苗除外)
8.矿物质
9.黏多醣
10.非人类动物材料(或此类材料的合成替代品)
11.脂质
12.由蜜蜂产生或获得的物质
13.糖、多醣或碳水化合物
14.维生素或维生素原

TGA採用两级系统来评估补充药物的风险：
1.风险较低的药物可以列入澳洲治疗用品登记册( ARTG)。
2.风险较高的药物必须在 ARTG 上註册。

In Australia, health supplements are known as complementary medicines and are regulated by the Therapeutic Goods Administration (TGA). A product is considered a complementary medicine when its ingredients contain at least one of the specified active ingredients.

Designated Active Ingredients:

1. Amino acid
2. Charcoal
3. Choline salts
4. Essential oils
5. Plant or herbal materials (or synthetic substitutes for such materials)
6. Homeopathic preparations
7. Intact or extracted microorganisms (except vaccines)
8. Minerals
9. Mucopolysaccharides
10. Non-human animal materials (or synthetic substitutes for such materials)
11. Lipids
12. Substances produced or obtained by bees
13. Sugars, polysaccharides, or carbohydrates
14. Vitamins or provitamins

The TGA uses a two-level system to assess the risks of complementary medicines:

1. Drugs with lower risk can be included in the Australian Register of Therapeutic Goods (ARTG).
2. Drugs with higher risk must be registered on ARTG.

【参考连结】
https://www.tga.gov.au/overview-regulation-complementary-medicines-australia
https://www.tga.gov.au/news/blog/how-are-vitamins-regulated-australia

HLF-TW-20
外国公司要到澳洲销售保健食品，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？假如要，其必要条件是什么？所需文件及申请程序为何？网页？

If a foreign company wants to sell health food in Australia, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
无营业特许证。
No business license.

【参考连结】
https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-listed-medicines-and-registered-complementary-medicines

HLF-TW-25
假如需要办理，请问澳洲有专业服务公司可以协助办理保健食品公司营业许可证？
Evershine RD：
无营业特许证。

HLF-TW-30
外国公司要到澳洲销售保健食品，可以指派澳洲公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什么？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？

If a foreign company wants to sell health food in Australia, can it assign a Australia company to act as a business agent? What are the requests for acting as a business agent? What are the required documents and application procedures? What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
可以，补充药物须完成产品註册即可销售，营业代理人无须营业註册。

产品安全
1.最主要的责任为治疗用品登记册ARTG的负责人，负责需要确保补充药物的安全、品质。
2.当有不安全事件发生，製造商有责任进行安全警报、召回等配套措施。
3.ARTG负责人、经销商、製造商、进口商、零售商皆有责任监察补充药物的安全性，当发生不良事件时主动向TGA报告。

Yes, supplementary medicines can be sold only after completing product registration, and business agents do not need business registration.

Product Safety

1. The main responsibility is the person in charge of the ARTG of the Therapeutic Goods Register, who is responsible for ensuring the safety and quality of supplementary medicines.
2. When an unsafe incident occurs, the manufacturer is responsible for safety alarms, recalls and other supporting measures.
3. The person in charge of ARTG, distributors, manufacturers, importers, and retailers are all responsible for monitoring the safety of supplementary drugs, and actively report to TGA when adverse events occur.

【参考连结】
https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-listed-medicines-and-registered-complementary-medicines
https://www.tga.gov.au/resources/resource/guidance/reporting-adverse-events

HLF-TW-35

HLF-TW-40
外国公司销售到澳洲保健食品本身，进口前需要办理产品许可吗？如需要，哪个单位在管理？需要什么文件？申请程序为何？保健食品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？

Do foreign companies need to apply for an approval before importing health food sold to Australia? If yes, which authority is in charge? What documents are required? What is the application process? Do health food packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
须完成治疗用品登记册 (ARTG)註册。

澳洲治疗用品登记册 (ARTG) 的列表或註册号里，AUST L或AUST R。L 代表上市，R 代表註册。补充药物註册申请有五个级别(RCM 1 至 RCM 5)。每个级别都对应一个应用程序类别。与较高级别的申请相比，较低级别的申请需要较少的资料，费用较低且时间也较短。
分级

1. RCM 1
   ．必须在 ARTG 註册并经过全面安全评估。
   ．标籤、适应症和配方必须充分标示。
   ．申请后TGA 可以检核档案和 ARTG 记录的资料。
2. RCM 2
   ．安全性、品质和功效评估基于外国或外国司法管辖区主管监管机构的评估报告。
3. RCM 3
   ．针对的是彷製药，不需要生物等效性数据来评估的药物，或者已由 COB 评估，并需要 TGA 对以下其中一项进行独立评估：药物的安全性、品质、功效。
   ．RCM 3彷製药补充药物的条件：与经过充分评估的母药相比，拟议的彷製药必须具有相同的：活性成分的量、安全性和功效特性，以及母药提供的安全性和有效性数据不得受到保护、药物形式并被适当证明具有治疗等效性。
4. RCM 4，註册补充药物的申请，其中满足以下条件之一：
   ．申请已经过COB评估，需要TGA完成以下其中两个评估：药物的安全性、品质、功效。
   ．申请的是彷製药，需要生物等效性数据来评价药物。
   ．申请针对已註册的药物，且涉及以下一项或多项：药物适应症的扩展、药物使用的新方向、药物目标人群的增加。
5. RCM 5，如果不是 RCM(1至 4)并且适用以下其中一项：
   ．需要对产品的安全性、品质和功效进行独立评估
   ．该申请适用于已註册的药物，并且为：新剂型、一种新的活性、活性成分强、添加当时未在补充药物中使用的。

註册补充药物评估的时间范围和费用

1. RCM 1：初评通知工作日40天；评估时限45天。
2. RCM 2：初评通知工作日40天；评估时限90天。
3. RCM 3：初评通知工作日40天；评估时限150天。
4. RCM 4：初评通知工作日40天；评估时限180天。
5. RCM 5：初评通知工作日40天；评估时限210天。

註册补充药物所需的 资料

1. 一般要求
   ．英语：确保所有资料都是英文且可阅读。对于非英文资料，请附上原始语言的副本、完整英文翻译(如果需要帮助，可以通过国家笔译、口译认证机构(NAATI)网站寻找合格的译员)。
   ．字体和可读性：确保表格和图像足够大，并且即使在複印、扫描之后也能轻松阅读，并且任何阴影都不会影响可读性。建议文本不小于：12号字；表格内10号字；备註10号字。
   ．测量单位：使用公制单位。检查档案中的所有文件是否引用了SI单位2或澳洲临床实践中普遍接受的单位(例如毫米汞柱，或法国压力表)的测量值。
   ．请求 (RFI)的回应：如果在评估您的档案时要求提供更多资料，请确保符合一般档案要求(可以接受最大40MB的电子邮件)。
   ．商业机密资料：无论是作为申请的一部分还是其他形式，都属于商业机密。
   2.模组资料
   ．模组1：行政 资料和处方资料。
   ．模组2：品质、安全性和临床数据摘要。
   ．模组3：品质。
   ．模组4：非临床数据(安全性)。
   ．模组5：临床数据(功效)。

申请流程

1. TGA 商业服务註册、验证
   註册帐号 (Client ID)
   ．担保人：担保人必须是澳洲居民或澳洲的法人团体并有在澳洲开展业务，且公司代表居住在澳洲。
   ．详细地址：街道、郊区/州、邮政编码、邮寄地址、公司联繫方式、账单详细讯息、电子邮件、电话、电子邮件。
   ．组织管理者：管理员全名(负责建立和维护组织的联繫)、电子邮件、电话。
   ．澳洲代表：必须保留至少一名澳洲代表，境外代理商请指定您所在组织的澳洲代表作为授权联繫人，需留存全名、电子邮件、电话。
   ．声明。
   缴交：电子邮件交至 TGA TBS 服务台：ebs@health.gov.au
   产品註册
   ．风险较高的药物必须在澳洲治疗产品登记册 (ARTG)上註册，其中涉及对产品的品质、安全性和有效性进行单独评估。
   ．含有预先批准的低风险成分且声明有限的低风险药物可以在 (ARTG)上列出。
   产品註册资料：标籤(包括标籤清单)、广告、SPF 测试结果的再现性、稳定性测试、製造和品质控制、允许的成分、新成分。
   网页：https://www.tga.gov.au/
2. 检查成分
   ．缴交成分、专有成分资料。
   ．包含：澳洲批准名称(化学物质)、草药的植物学名称(经批准的草药名称)、草药成分名称。
   ．透过电子邮件向TGA Names缴交相关资料
3. 确保有效的 GMP
   ．对于海外製造商，需具备TGA 颁发的GMP。
   ．如果海外製造商没有当下有效的 GMP 许可(由 TGA 颁发)，就无法完成您的申请。所以需要确保GMP 许可在评估期限内不会过期。
4. 确定申请类别
   ．资料要求和评估时间范围随着分级所需的评估和风险增加，因此正确类别非常重要。
5. 检查指南
   ．在计划註册补充药物的申请时，需要确定并了解相关的技术和监管要求和指南。
6. 豁免申请
   ．如果符合豁免条件，则需要检附豁免资料。
   7.编排数据
   ．将检附的档案依照标示编排。
   8.支付费用
   9.完成註册

标籤
1.产品的标籤包括附在容器(例如：瓶子、管子、小袋等)和初级包装(例如：纸箱)上的标籤。申办者必须确保药物随附的产品标籤和任何印刷资料(例如：包装说明书)符合所有相关法规(包括广告)，然后才能在澳洲销售。
2.图形、徽章和符号：标籤上的非企业图形、徽章或符号应与产品批准的详细资料一致，包括产品声称的治疗用途。
3.广告、专业推荐、认可、贊助的声明都必须符合治疗用品广告准则。
4.提及其他产品：在标籤中提及贊助商的其他产品是允许的，前提是这些产品包含在ARTG中(或豁免)。
5.无麸质或无糖之类的声明必须属实。
6.只有当网站上的资料(包括该网站的任何直接链接)与该产品的 ARTG 中包含的资料一致时，才可以在标籤上标示。
7.标籤说明：作为一般准则，新配方或现在等标籤说明不可用于描述已在澳洲上市和推广超过12年的任何产品、介绍或治疗适应症/声明。
8.辅料成分：辅料成分不需要在药物标籤上标示，除非是受限制的成分，例如：包含在毒物标准中。如果申办者选择在药物标籤上披露一种(非强制性)辅料，则必须标示出所有的辅料。
9.所需的标籤必须以英语书写。

The Register of Therapeutic Goods (ARTG) is required.

AUST L or AUST R on the Australian Register of Therapeutic Goods (ARTG) listing or registration number. L stands for Listed and R stands for Registered. There are five levels of registration applications for supplementary medicines (RCM 1 to RCM 5). Each level corresponds to an application category. Lower level applications require fewer documents, are less expensive and take less time than higher level applications.

Grade

1. RCM 1
   ．Must be registered with ARTG and undergo a full safety assessment.
   ．Labeling, indications and formulations must be adequately declared.
   ．After application, TGA can review the information on file and ARTG records.
2. RCM 2
   ．Safety, quality and efficacy assessments are based on assessment reports from foreign countries or competent regulatory agencies in foreign jurisdictions.
3. RCM 3
   ．For generic drugs, drugs that do not require bioequivalence data for evaluation, or have been evaluated by COB, and require independent evaluation by TGA for one of the following: safety, quality, efficacy of the drug.
   ．RCM 3 Conditions for Generic Complementary Medicines: Compared to a fully evaluated parent drug, the proposed generic drug must have the same: amount of active ingredient, safety and efficacy profile, and safety and efficacy data provided by the parent drug Shall not be protected, drug form and duly demonstrated therapeutic equivalence.
4. RCM 4, Application for Registration of Complementary Medicine, where one of the following conditions is met:
   ．The application has been evaluated by COB, and TGA needs to complete two of the following evaluations: drug safety, quality, and efficacy.
   ．The application is a generic drug, which requires bioequivalence data to evaluate the drug.
   ．The application is for a registered drug and involves one or more of the following: expansion of drug indications, new direction of drug use, increase in target population of the drug.
5. RCM 5, if not RCM (1 to 4) and one of the following applies:
   ．Requires independent assessment of product safety, quality and efficacy
   ．The application is for a drug that is already registered and is: a new dosage form, a new active, a strong active ingredient, an addition not currently used in complementary medicine.

Time Frame and Cost of Registering for Complementary Drug Assessments

1. RCM 1: 40 working days for initial evaluation notification; 45 days for evaluation.
2. RCM 2: 40 working days for initial evaluation notification; 90 days for evaluation.
3. RCM 3: 40 working days for initial evaluation notification; 150 days for evaluation.
4. RCM 4: 40 working days for initial evaluation notification; 180 days for evaluation.
5. RCM 5: 40 working days for initial evaluation notification; 210 days for evaluation.

Information Required to Register Complementary Medicines

1. General requirements
   ．English: Make sure all materials are in English and readable. For non-English material, please attach a copy in the original language, a full English translation (if assistance is needed, qualified translators can be found through the National Accreditation Institute for Translators, Interpreters (NAATI) website).
   ．Fonts and readability: Make sure tables and images are large enough to be easily read even after copying, scanning, and that any shading does not affect readability. It is suggested that the text should not be smaller than: 12-point font; 10-point font in the form; 10-point font for remarks.
   ．Units of measure: Use metric units. Check that all documents on file refer to measurements in SI units2 or units generally accepted in Australian clinical practice (eg millimeters of mercury, or French manometers).
   ．Responses to Requests (RFIs): If additional information is requested in evaluating your file, please ensure that general file requirements are met (emails up to 40MB are accepted).
   ．Commercial Confidential Information: Whether as part of an application or otherwise, it is commercially confidential.
2. Module information
   ．Module 1: Administrative data and prescribing data.
   ．Module 2: Summary of quality, safety and clinical data.
   ．Module 3: Quality.
   ．Module 4: Non-clinical data (safety).
   ．Module 5: Clinical data (efficacy).

application process

1. TGA commercial service registration and verification
   Register account (Client ID)
   ．Guarantor: The guarantor must be an Australian resident or an Australian body corporate and have a business in Australia, and the company representative lives in Australia.
   ．Address Details: Street, Suburb/State, Zip Code, Postal Address, Business Contact, Billing Details, Email, Phone, Email.
   ．Organization Manager: Administrator’s full name (responsible for establishing and maintaining connections to the organization), email, phone.
   ．Australian representative: At least one Australian representative must be retained. For overseas agents, please designate the Australian representative of your organization as the authorized contact person. Full name, email, and phone number must be kept.
   ．Statement.
   To submit: Email to TGA TBS Help Desk: ebs@health.gov.au
   product registration
   ．Higher risk medicines must be registered on the Australian Register of Therapeutic Goods (ARTG), which involves an individual assessment of the quality, safety and effectiveness of the product.
   ．Low-risk medicines that contain pre-approved low-risk ingredients with limited claims can be listed on (ARTG).
   Product registration information: labeling (including label listing), advertising, reproducibility of SPF test results, stability testing, manufacturing and quality control, allowed ingredients, new ingredients.
2. Check ingredients
   ．Submit ingredient and proprietary ingredient information.
   ．Contains: Australia Approved Name (Chemical Substance), Botanical Name of Herb (Approved Herbal Name), Herbal Ingredient Name.
   ．Submit relevant information to TGA Names via email
3. Ensuring effective GMP
   ．For overseas manufacturers, GMP issued by TGA is required.
   ．If the overseas manufacturer does not have a current GMP license (issued by the TGA), your application cannot be completed. So it is necessary to ensure that the GMP license will not expire within the evaluation period.
4. Determine the application category
   ．Data requirements and assessment timeframes increase with the assessment and risk required for classification, so the correct category is important.
5. Inspection Guidelines
   ．When planning to register an application for a complementary medicine, the relevant technical and regulatory requirements and guidelines need to be identified and understood.
6. Application for exemption
   ．If you meet the exemption conditions, you need to attach the exemption information.
7. Orchestrate data
   ．Arrange the attached files according to the label.
8. Pay fees
9. Complete the registration

Label

1. Product labeling includes labels attached to containers (eg bottles, tubes, sachets, etc.) and primary packaging (eg cartons). Sponsors must ensure that the product label and any printed information accompanying the drug (for example: package leaflet) complies with all relevant regulations (including advertising) before it can be sold in Australia.
2. Graphics, emblems and symbols: Non-corporate graphics, emblems or symbols on the label should be consistent with the product approval details, including the product’s claimed therapeutic use.
3. Advertisements, professional recommendations, endorsements, and sponsorship statements must comply with the Therapeutic Goods Advertising Guidelines.
4. References to other products: References to Sponsor’s other products in the label are permitted provided they are included in (or exempted from) the ARTG.
5. Claims like gluten-free or sugar-free must be true.
6. Only if the information on the website (including any direct links to the website) is consistent with the information contained in the ARTG for the product, may it be indicated on the label.
7. Label statement: As a general guideline, label statements such as new formula or present cannot be used to describe any product, introduction or treatment indication/claim that has been marketed and promoted in Australia for more than 12 years.
8. Excipient ingredients: Excipient ingredients do not need to be declared on the drug label, unless they are restricted ingredients, for example: included in the poison standard. If a sponsor chooses to disclose an (optional) excipient on a drug label, all excipients must be identified.
9. Required labels must be written in English.

【参考连结】
https://www.tga.gov.au/sites/default/files/general-dossier-requirements.pdf
https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-listed-medicines-and-registered-complementary-medicines
https://www.tga.gov.au/overview-regulation-complementary-medicines-australia

HLF-TW-45

HLF-TW-50
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什么文件？申请程序为何？保健食品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？？网页？

Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do health food packaging and labeling require prior approval? Which languages are allowed?? Website?
Evershine RD：
可以，须完成治疗用品登记册 (ARTG)註册。

澳洲治疗用品登记册 (ARTG) 的列表或註册号里，AUST L或AUST R。L 代表上市，R 代表註册。补充药物註册申请有五个级别(RCM 1 至 RCM 5)。每个级别都对应一个应用程序类别。与较高级别的申请相比，较低级别的申请需要较少的资料，费用较低且时间也较短。
分级

1. RCM 1
   ．必须在 ARTG 註册并经过全面安全评估。
   ．标籤、适应症和配方必须充分标示。
   ．申请后TGA 可以检核档案和 ARTG 记录的资料。
2. RCM 2
   ．安全性、品质和功效评估基于外国或外国司法管辖区主管监管机构的评估报告。
3. RCM 3
   ．针对的是彷製药，不需要生物等效性数据来评估的药物，或者已由 COB 评估，并需要 TGA 对以下其中一项进行独立评估：药物的安全性、品质、功效。
   ．RCM 3彷製药补充药物的条件：与经过充分评估的母药相比，拟议的彷製药必须具有相同的：活性成分的量、安全性和功效特性，以及母药提供的安全性和有效性数据不得受到保护、药物形式并被适当证明具有治疗等效性。
4. RCM 4，註册补充药物的申请，其中满足以下条件之一：
   ．申请已经过COB评估，需要TGA完成以下其中两个评估：药物的安全性、品质、功效。
   ．申请的是彷製药，需要生物等效性数据来评价药物。
   ．申请针对已註册的药物，且涉及以下一项或多项：药物适应症的扩展、药物使用的新方向、药物目标人群的增加。
5. RCM 5，如果不是 RCM(1至 4)并且适用以下其中一项：
   ．需要对产品的安全性、品质和功效进行独立评估
   ．该申请适用于已註册的药物，并且为：新剂型、一种新的活性、活性成分强、添加当时未在补充药物中使用的。

註册补充药物评估的时间范围和费用

1. RCM 1：初评通知工作日40天；评估时限45天。
2. RCM 2：初评通知工作日40天；评估时限90天。
3. RCM 3：初评通知工作日40天；评估时限150天。
4. RCM 4：初评通知工作日40天；评估时限180天。
5. RCM 5：初评通知工作日40天；评估时限210天。

註册补充药物所需的 资料

1. 一般要求
   ．英语：确保所有资料都是英文且可阅读。对于非英文资料，请附上原始语言的副本、完整英文翻译(如果需要帮助，可以通过国家笔译、口译认证机构(NAATI)网站寻找合格的译员)。
   ．字体和可读性：确保表格和图像足够大，并且即使在複印、扫描之后也能轻松阅读，并且任何阴影都不会影响可读性。建议文本不小于：12号字；表格内10号字；备註10号字。
   ．测量单位：使用公制单位。检查档案中的所有文件是否引用了SI单位2或澳洲临床实践中普遍接受的单位(例如毫米汞柱，或法国压力表)的测量值。
   ．请求 (RFI)的回应：如果在评估您的档案时要求提供更多资料，请确保符合一般档案要求(可以接受最大40MB的电子邮件)。
   ．商业机密资料：无论是作为申请的一部分还是其他形式，都属于商业机密。
   2.模组资料
   ．模组1：行政 资料和处方资料。
   ．模组2：品质、安全性和临床数据摘要。
   ．模组3：品质。
   ．模组4：非临床数据(安全性)。
   ．模组5：临床数据(功效)。

申请流程

1. TGA 商业服务註册、验证
   註册帐号 (Client ID)
   ．担保人：担保人必须是澳洲居民或澳洲的法人团体并有在澳洲开展业务，且公司代表居住在澳洲。
   ．详细地址：街道、郊区/州、邮政编码、邮寄地址、公司联繫方式、账单详细讯息、电子邮件、电话、电子邮件。
   ．组织管理者：管理员全名(负责建立和维护组织的联繫)、电子邮件、电话。
   ．澳洲代表：必须保留至少一名澳洲代表，境外代理商请指定您所在组织的澳洲代表作为授权联繫人，需留存全名、电子邮件、电话。
   ．声明。
   缴交：电子邮件交至 TGA TBS 服务台：ebs@health.gov.au
   产品註册
   ．风险较高的药物必须在澳洲治疗产品登记册 (ARTG)上註册，其中涉及对产品的品质、安全性和有效性进行单独评估。
   ．含有预先批准的低风险成分且声明有限的低风险药物可以在 (ARTG)上列出。
   产品註册资料：标籤(包括标籤清单)、广告、SPF 测试结果的再现性、稳定性测试、製造和品质控制、允许的成分、新成分。
2. 检查成分
   ．缴交成分、专有成分资料。
   ．包含：澳洲批准名称(化学物质)、草药的植物学名称(经批准的草药名称)、草药成分名称。
   ．透过电子邮件向TGA Names缴交相关资料
3. 确保有效的 GMP
   ．对于海外製造商，需具备TGA 颁发的GMP。
   ．如果海外製造商没有当下有效的 GMP 许可(由 TGA 颁发)，就无法完成您的申请。所以需要确保GMP 许可在评估期限内不会过期。
4. 确定申请类别
   ．资料要求和评估时间范围随着分级所需的评估和风险增加，因此正确类别非常重要。
5. 检查指南
   ．在计划註册补充药物的申请时，需要确定并了解相关的技术和监管要求和指南。
6. 豁免申请
   ．如果符合豁免条件，则需要检附豁免资料。
   7.编排数据
   ．将检附的档案依照标示编排。
   8.支付费用
   9.完成註册

标籤
1.产品的标籤包括附在容器(例如：瓶子、管子、小袋等)和初级包装(例如：纸箱)上的标籤。申办者必须确保药物随附的产品标籤和任何印刷资料(例如：包装说明书)符合所有相关法规(包括广告)，然后才能在澳洲销售。
2.图形、徽章和符号：标籤上的非企业图形、徽章或符号应与产品批准的详细资料一致，包括产品声称的治疗用途。
3.广告、专业推荐、认可、贊助的声明都必须符合治疗用品广告准则。
4.提及其他产品：在标籤中提及贊助商的其他产品是允许的，前提是这些产品包含在ARTG中(或豁免)。
5.无麸质或无糖之类的声明必须属实。
6.只有当网站上的资料(包括该网站的任何直接链接)与该产品的 ARTG 中包含的资料一致时，才可以在标籤上标示。
7.标籤说明：作为一般准则，新配方或现在等标籤说明不可用于描述已在澳洲上市和推广超过12年的任何产品、介绍或治疗适应症/声明。
8.辅料成分：辅料成分不需要在药物标籤上标示，除非是受限制的成分，例如：包含在毒物标准中。如果申办者选择在药物标籤上披露一种(非强制性)辅料，则必须标示出所有的辅料。
9.所需的标籤必须以英语书写。

Yes. The Register of Therapeutic Goods (ARTG) is required.

AUST L or AUST R on the Australian Register of Therapeutic Goods (ARTG) listing or registration number. L stands for Listed and R stands for Registered. There are five levels of registration applications for supplementary medicines (RCM 1 to RCM 5). Each level corresponds to an application category. Lower level applications require fewer documents, are less expensive and take less time than higher level applications.

Grade

1. RCM 1
   ．Must be registered with ARTG and undergo a full safety assessment.
   ．Labeling, indications and formulations must be adequately declared.
   ．After application, TGA can review the information on file and ARTG records.
2. RCM 2
   ．Safety, quality and efficacy assessments are based on assessment reports from foreign countries or competent regulatory agencies in foreign jurisdictions.
3. RCM 3
   ．For generic drugs, drugs that do not require bioequivalence data for evaluation, or have been evaluated by COB, and require independent evaluation by TGA for one of the following: safety, quality, efficacy of the drug.
   ．RCM 3 Conditions for Generic Complementary Medicines: Compared to a fully evaluated parent drug, the proposed generic drug must have the same: amount of active ingredient, safety and efficacy profile, and safety and efficacy data provided by the parent drug Shall not be protected, drug form and duly demonstrated therapeutic equivalence.
4. RCM 4, Application for Registration of Complementary Medicine, where one of the following conditions is met:
   ．The application has been evaluated by COB, and TGA needs to complete two of the following evaluations: drug safety, quality, and efficacy.
   ．The application is a generic drug, which requires bioequivalence data to evaluate the drug.
   ．The application is for a registered drug and involves one or more of the following: expansion of drug indications, new direction of drug use, increase in target population of the drug.
5. RCM 5, if not RCM (1 to 4) and one of the following applies:
   ．Requires independent assessment of product safety, quality and efficacy
   ．The application is for a drug that is already registered and is: a new dosage form, a new active, a strong active ingredient, an addition not currently used in complementary medicine.

Time Frame and Cost of Registering for Complementary Drug Assessments

1. RCM 1: 40 working days for initial evaluation notification; 45 days for evaluation.
2. RCM 2: 40 working days for initial evaluation notification; 90 days for evaluation.
3. RCM 3: 40 working days for initial evaluation notification; 150 days for evaluation.
4. RCM 4: 40 working days for initial evaluation notification; 180 days for evaluation.
5. RCM 5: 40 working days for initial evaluation notification; 210 days for evaluation.

Information Required to Register Complementary Medicines

1. General requirements
   ．English: Make sure all materials are in English and readable. For non-English material, please attach a copy in the original language, a full English translation (if assistance is needed, qualified translators can be found through the National Accreditation Institute for Translators, Interpreters (NAATI) website).
   ．Fonts and readability: Make sure tables and images are large enough to be easily read even after copying, scanning, and that any shading does not affect readability. It is suggested that the text should not be smaller than: 12-point font; 10-point font in the form; 10-point font for remarks.
   ．Units of measure: Use metric units. Check that all documents on file refer to measurements in SI units2 or units generally accepted in Australian clinical practice (eg millimeters of mercury, or French manometers).
   ．Responses to Requests (RFIs): If additional information is requested in evaluating your file, please ensure that general file requirements are met (emails up to 40MB are accepted).
   ．Commercial Confidential Information: Whether as part of an application or otherwise, it is commercially confidential.
2. Module information
   ．Module 1: Administrative data and prescribing data.
   ．Module 2: Summary of quality, safety and clinical data.
   ．Module 3: Quality.
   ．Module 4: Non-clinical data (safety).
   ．Module 5: Clinical data (efficacy).

application process

1. TGA commercial service registration and verification
   Register account (Client ID)
   ．Guarantor: The guarantor must be an Australian resident or an Australian body corporate and have a business in Australia, and the company representative lives in Australia.
   ．Address Details: Street, Suburb/State, Zip Code, Postal Address, Business Contact, Billing Details, Email, Phone, Email.
   ．Organization Manager: Administrator’s full name (responsible for establishing and maintaining connections to the organization), email, phone.
   ．Australian representative: At least one Australian representative must be retained. For overseas agents, please designate the Australian representative of your organization as the authorized contact person. Full name, email, and phone number must be kept.
   ．Statement.
   To submit: Email to TGA TBS Help Desk: ebs@health.gov.au
   product registration
   ．Higher risk medicines must be registered on the Australian Register of Therapeutic Goods (ARTG), which involves an individual assessment of the quality, safety and effectiveness of the product.
   ．Low-risk medicines that contain pre-approved low-risk ingredients with limited claims can be listed on (ARTG).
   Product registration information: labeling (including label listing), advertising, reproducibility of SPF test results, stability testing, manufacturing and quality control, allowed ingredients, new ingredients.
2. Check ingredients
   ．Submit ingredient and proprietary ingredient information.
   ．Contains: Australia Approved Name (Chemical Substance), Botanical Name of Herb (Approved Herbal Name), Herbal Ingredient Name.
   ．Submit relevant information to TGA Names via email
3. Ensuring effective GMP
   ．For overseas manufacturers, GMP issued by TGA is required.
   ．If the overseas manufacturer does not have a current GMP license (issued by the TGA), your application cannot be completed. So it is necessary to ensure that the GMP license will not expire within the evaluation period.
4. Determine the application category
   ．Data requirements and assessment timeframes increase with the assessment and risk required for classification, so the correct category is important.
5. Inspection Guidelines
   ．When planning to register an application for a complementary medicine, the relevant technical and regulatory requirements and guidelines need to be identified and understood.
6. Application for exemption
   ．If you meet the exemption conditions, you need to attach the exemption information.
7. Orchestrate data
   ．Arrange the attached files according to the label.
8. Pay fees
9. Complete the registration

Label

1. Product labeling includes labels attached to containers (eg bottles, tubes, sachets, etc.) and primary packaging (eg cartons). Sponsors must ensure that the product label and any printed information accompanying the drug (for example: package leaflet) complies with all relevant regulations (including advertising) before it can be sold in Australia.
2. Graphics, emblems and symbols: Non-corporate graphics, emblems or symbols on the label should be consistent with the product approval details, including the product’s claimed therapeutic use.
3. Advertisements, professional recommendations, endorsements, and sponsorship statements must comply with the Therapeutic Goods Advertising Guidelines.
4. References to other products: References to Sponsor’s other products in the label are permitted provided they are included in (or exempted from) the ARTG.
5. Claims like gluten-free or sugar-free must be true.
6. Only if the information on the website (including any direct links to the website) is consistent with the information contained in the ARTG for the product, may it be indicated on the label.
7. Label statement: As a general guideline, label statements such as new formula or present cannot be used to describe any product, introduction or treatment indication/claim that has been marketed and promoted in Australia for more than 12 years.
8. Excipient ingredients: Excipient ingredients do not need to be declared on the drug label, unless they are restricted ingredients, for example: included in the poison standard. If a sponsor chooses to disclose an (optional) excipient on a drug label, all excipients must be identified.
9. Required labels must be written in English.

【参考连结】
https://www.tga.gov.au/sites/default/files/general-dossier-requirements.pdf
https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-listed-medicines-and-registered-complementary-medicines
https://www.tga.gov.au/overview-regulation-complementary-medicines-australia

HLF-TW-55

HLF-TW-60
经过核准登记的保健食品，进口到澳洲要检附什么文件？经过什么手续？在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

What documents are required when importing approved health food into Australia? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
澳洲药物管制办公室 (ODC)规范麻醉药物和精神药物、前体物质以及合成代谢药物和雄性激素药物的进口商需申请进口许可证。如果没有包含管制项目，则无需申请进口许可证。
1.网页：https://www.odc.gov.au/importers
2.申请资料
．申请人详细资料(主要许可证持有者)：姓名、职务、电话号码、联繫电子邮件。
．企业资料：公司/组织名称、ABN/ACN、澳洲企业或公司编号、主要电子邮件地址、公司识别号、街道地址、邮寄地址、进出口原因、需要受控物质的目的。
．船务代理或报关代理：海关或货运代理的公司的名称、地址和提供的服务。
．持有的州/地区许可证：显示每个此类许可证的全名、许可证号码及其有效期。
．储存与安全：提供受控物质的储存、使用或供应场所的详细资讯。场所的安全必须适合申请人将进口的物质和数量。
．最后一次安全报告的日期以及所在州/地区卫生部门官员最后一次进行安全检查的日期。
．提供每类药物(S4、S8、S9)运输安全措施的详细资讯，并说明由谁负责药物运输。
．授权联繫人：许可证持有者可以指定人员代表其提交和讨论进出口许可证申请。许可证持有者应说明作为授权联繫人的每个人的全名和职位。
．声明与同意
3.缴交申请
．纸本：药物管制办公室 麻醉品管制科
．电子邮件：NCS@health.gov.au

海关
进口流程

1. 执照和许可证：麻醉药物和精神药物、前体物质以及合成代谢药物和雄性激素药物的进口商需向澳洲药物管制办公室 (ODC)申请进口许可证。如果没有包含管制项目，则无需申请进口许可证。
2. 估价：所有进入澳洲的进口商品都需要准确估价，以计算相关关税、关税、费用和税费。交易价格以进口货物的实际支付(或应付)价格为基础，并作一定调整。海关在计算交易价值时使用货物出口当天(而不是货物到达澳洲当天)的汇率。
3. 税费、关税和收费
4. 标籤和说明：标籤需要符合规范，以英文标示并且容易阅读。如果商品不符合标籤要求，可能会被扣押。
5. 进口报关(报关单分为三种)：价值超过1000 澳元的物品的进口报关单、通过空运或海运到达且价值低于 1000 澳元的物品的自评清关 (SAC)声明、价值超过1000 澳元的清关前入库物品的仓库申报单(N20)。
   6.进口需要的资料
   ．贸易合约
   ．装箱单
   ．商业发票
   ．提单
   ．原产地证明文件
   ．成分分析表等。

无销售通知。

The Australian Office of Drug Control (ODC) regulates importers of narcotic and psychotropic substances, precursor substances, and anabolic and androgenic drugs to apply for an import license. If no controlled items are included, there is no need to apply for an import license.

1. URL: https://www.odc.gov.au/importers
2. Application information
   ．Applicant Details (Principal Licensee): Name, Title, Phone Number, Contact Email.
   ．Business information: company/organization name, ABN/ACN, Australian business or company number, primary email address, company identification number, street address, postal address, reason for import or export, purpose for which controlled substances are required.
   ．Shipping Agent or Customs Broker: Name, address, and services of the customs or freight forwarding company.
   ．State/Territory Licenses Held: Display the full name, license number, and expiration date of each such license.
   ．Storage and Security: Provide details of where controlled substances are stored, used or supplied. The security of the premises must be appropriate for the substance and quantity that the applicant will import.
   ．Date of last safety report and date of last safety inspection by state/territory health department officials.
   ．Provide details of the transport security measures for each drug class (S4, S8, S9) and describe who is responsible for transporting the drug.
   ．Authorized Contact: The license holder may designate someone to submit and discuss import and export license applications on its behalf. Licensee shall state the full name and title of each individual who is an authorized contact.
   ．Declaration and Consent
   3.Submit the application
   ．On paper: Office of Drug Control Narcotics Control Section
   ．Email: NCS@health.gov.au

Customs
Import process

1. Licenses and Permits: Importers of narcotic and psychotropic substances, precursor substances, and anabolic and androgenic drugs need to apply for an import license from the Australian Office of Drug Control (ODC). If no controlled items are included, there is no need to apply for an import license.
2. Valuation: All imported goods into Australia require an accurate valuation in order to calculate relevant duties, duties, fees and taxes. The transaction price is based on the actual payment (or payable) price of the imported goods, with certain adjustments. Customs uses the exchange rate on the day the goods are exported (not the day the goods arrive in Australia) when calculating the transaction value.
3. Taxes, duties and charges
4. Labeling and Instructions: Labeling needs to be compliant, in English and easy to read. Items may be seized if they do not meet labeling requirements.
5. Import customs declaration (customs declarations are divided into three types): import customs declaration for items worth more than AUD 1,000, self-assessment clearance (SAC) statement for items arriving by air or sea with a value of less than AUD 1,000, and declarations for items worth more than AUD 1,000 Warehouse declaration form (N20) for goods in storage before customs clearance.
6. Information required for import
   ．Trade contract
   ．Packing List
   ．Commercial invoice
   ．Bill of lading
   ．Certificate of Origin
   ．Component analysis table, etc.

No sale notification.
【参考连结】
https://www.odc.gov.au/importers
https://www.abf.gov.au/importing-exporting-and-manufacturing/importing/how-to-import/requirements
https://business.gov.au/products-and-services/importing/importing-and-your-business

HLF-TW-70
澳洲保健食品审核机构，需要附上的实验室检验资料有哪些? 网页？

What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
微生物检测
1.分类资料：提供微生物的分类讯息(包括属、种类、菌株名称/代码/培养物保存编号)、培养物来源和生产方法。应提供批准的生物名称(ABN)，否则必须提供有关命名申请的信件。 ．证明微生物作为活性成分的品质所需的讯息。
．注意强制性要求。
．列出申请的药物。
．说明微生物是否源自或含有转基因物质。
．如果该物质源自转基因生物体，或者在製造过程中使用了转基因生物体，请证明最终物质中不存在这种物质。
2如果该物质是经过基因改造的活微生物，请提供一份声明，表明该生物体不受基因技术法规约束。

製造细节
1.製造过程和过程控制的描述
应使用药典或其他经过验证的程序提供有关培养物建立、培养物和培养基、储存条件、孵化、批量大小的讯息。申请人须提供微生物的来源及其在菌株开发过程中的历史(包括基因工程步骤)，以及基因工程步骤的一些实例，包括：抗生素抗性基因的插入或删除、产毒和/或致病属性的减少、表达病原体毒力因子的重组蛋白的使用。
2.对于非活性微生物，还必须描述灭活方法。由于不同的灭活方法和过程可能会影响细胞膜的完整性，申请人应採取措施确保并证明细胞在灭活后保持完整和完整。
3.源自或含有转基因生物 (GMO)的物质受到基因技术法和基因技术条例的监管，其中包括对进口、製造、运输、储存和处置的监管。在考虑进口、製造或供应治疗性商品中的转基因生物的过程中，应该儘早联繫基因技术监管机构。
4.对于所列药物物质，应按照材料控制、关键步骤和中间体控制、製造工艺开发和製造工艺验证和/或评估需提供其他製造详细讯息。

表徵
1.一个物种的菌株与菌株之间的遗传差异转化为不同蛋白质的编码；差异可能是功能性的，并对作为活性成分的微生物的安全性和品质产生影响。评估菌株的特徵应阐明其身份，建立合适的分析测试，并鑑定杂质和附带成分。

2.对于活微生物，特徵描述还应包括抗菌素耐药性和敏感性概况的详细讯息，以及解决毒力因子、产毒和致病属性缺失的讯息。

一般特性
1.理化性质：应提供与微生物表徵相关的物理化学特性的讯息。包括：外观、颜色、状态、质地、气味、溶解度、乾燥失重、硫酸盐、pH、微观和宏观形态等。
2.抗菌药物耐药性和敏感性：
．含有活微生物作为活性成分的治疗产品不应增加将抗生素耐药性转移给宿主的风险。考虑的抗生素应是与澳洲人类药物使用相关的抗生素，并由澳洲抗菌素耐药性战略和技术谘询小组 (ATAG)根据重要性分类为高、中或低。
．儘管抗真菌药物耐药性的发展速度不如抗生素耐药性，但含有活微生物作为活性成分的治疗药物不应对宿主的真菌耐药性施加选择性压力。

3.抗生素耐药性和敏感性概况
．提供讯息以证明含有活微生物作为活性成分的预期拟议物质或 RCM 的抗菌药物耐药性和敏感性。
．所列药物中新物质的申请要求应提供与微生物表徵相关的物理化学特性的讯息。包括外观、颜色、状态、质地、气味、溶解度、乾燥失重、硫酸盐、pH、微观和宏观形态等。
．对于活微生物，特徵描述还应包括抗菌素耐药性和敏感性概况的详细讯息，以及解决毒力因子、产毒和致病属性缺失的讯息。
．对于 RCM，应按照相关部分的概述提供其他製造细节应证明对 ASTAG 定义的至少两种市售抗生素(例如氨苄青霉素、链霉素、红霉素、克林霉素、四环素、氯霉素)的治疗浓度的敏感性。
．应使用国际公认的标准方法确定最低抑菌浓度 (MIC)。
4.抗菌素耐药基因
．在有基因组数据的情况下，建议在至少两个维护的数据库中对抗菌素耐药性基因进行计算机搜索，以全面了解所评估的活微生物的相关安全性方面。使用从全基因组数据集中捕获抗菌素耐药基因的数据库进行计算机分析，可以识别任何潜在的遗传耐药性。⼀般来说，应报告至少80%(在蛋白质水平或核苷酸水平)和 70%长度的主题序列命中的查询序列。
5.缺乏水平阻力可转移性
．宿主中的内源性微生物组充当针对病原体的基线防御。
．因此，不希望将编码抗微生物剂抗性的基因水平转移至宿主微生物组。接受评估的活微生物的基因组应不含可转化为抗菌素耐药表型的功能性和可转移抗菌素耐药性基因 DNA。当基因组数据可用时，需要搜索移动或可转座的遗传元件。
6.不存在毒力因子
．应使用以下方法寻找编码已知毒力因子(毒素、介导微生物附着的细胞表面蛋白质、保护微生物的细胞表面碳水化合物和蛋白质、可能导致微生物致病性的水解酶、入侵和黏附因子)的基因在已发布的数据库中进行计算比较，用数据库中复盖范围长度的最⼩可用阈值。
．如果检测到毒力因子基因，则应提供旨在降低所用菌株毒力的任何菌株开发策略(包括基因工程)的详细讯息。在有基因组数据的情况下，建议在至少两个维护的数据库中对抗菌素耐药性基因进行计算机搜索，以全面了解所评估的活微生物的相关安全性。

身分
1.对于作为活性成分的所有微生物，都需要鑑定其属、种和菌株名称/代码/培养物保存编号。
2.蛋白质组学和表型方法：微生物的表型鑑定依赖于可能产生不同结果的形态学、生理学和生化特性。如果使用基因组方法充分确定了所评估的微生物的身份，则不需要蛋白质组学或表型方法。

测定
1.对于在所列药物中用作物质的活微生物，化验测试提供了经过验证的规范，以确定所评估的微生物的存在和数量(含量)。单个微生物菌株的计数或计数，以菌落形成单位(CFU)或活生物体数量表示，应通过适当的微生物计数测试来确定。
2.对于在所列药物中用作物质的非活性微生物，使用适当的微生物品质控制测试以灭活生物体数量来表达单个微生物菌株的计数或计数。如果在灭活步骤之前进行计数或细胞计数，则测定应表示为通过合适的微生物计数测试确定的灭活CFU。
．杂质和附带成分：杂质和附带成分是汙染物、作为生产副产品存在于微生物中或者在微生物的加工或储存期间产生的成分。

规格
1.应使用构图指南模板以构图指南的形式提供讯息，例如描述、表徵(鑑定、测定、杂质)分析方法和验收标准。
2.证明安全所需的讯息
．系统文献检索
．人类使用的历史和模式
．生物活性
．毒理学数据
．不良反应的性质、严重程度和频率列表

良好生产规范 (GMP)
1.GMP的基本原则是：
．无法对一批产品进行品质检验
．在製造过程的所有阶段，必须将品质融入到每批产品中。
2.向澳洲供应的海外製造商也必须符合可接受的 GMP 标准。
3.如果无法提供可接受的文件 GMP 证据，TGA 将以与澳洲製造商相同的方式进行现场检查。
4.GMP许可申请证据的任何文件必须是：
．原始文件准确且完整的副本。作为申请人，须对所提供文件的真实性负责，不接受大量编辑或更改的文件。
．英文版，或附有独立认证译员的英文译文。
．最新且有效的版本。
5.提供资料
．公认的监管机构的检验报告。
．製造商名称及住址。
．最新的证书。
．合作实验室的GLP证书须获得ISO认可。
．检验报告的范围涵盖应用范围，即无菌、剂型、原料药、生产步骤和所涵盖的建筑物。
．报告中清楚记录了检查所需的时间和检查团队的规模。
．监管检查清单：需要现场主文件(SMF)或同等文件，因为它提供有关製造商运营、设施和品质管理体系的资讯。
．拟供应产品清单：须确保物质或剂型在申请范围内、提供AUSTR/AUSTL编号。
．确保GMP、品质或技术协议。
．验证总体计划(VMP)。
．其他类型的证据：API声明等。

Microbial Detection

1. Classification information: Provide classification information of microorganisms (including genus, species, strain name/code/culture preservation number), culture source and production method. An Approved Biological Name (ABN) should be provided, otherwise a letter pertaining to the nomenclature application must be provided. ． Information required to demonstrate the quality of microorganisms as active ingredients.
   ．Note the mandatory requirements.
   ．List the requested drug.
   ．State whether the microorganism is derived from or contains genetically modified material.
   ．If the substance is derived from a GMO, or a GMO was used in the manufacturing process, please demonstrate that the substance is not present in the final substance.
   2 If the substance is a living genetically modified microorganism, please provide a statement that the organism is not subject to the Gene Technology Regulation.

manufacturing details

1. Description of manufacturing process and process control
   Information on culture establishment, culture and medium, storage conditions, incubation, batch size should be provided using pharmacopoeial or other validated procedures. Applicants are required to provide the source of the microorganism and its history in the strain development process (including genetic engineering steps), and some examples of genetic engineering steps including: insertion or deletion of antibiotic resistance genes, toxigenic and/or pathogenic properties reduction, the use of recombinant proteins expressing pathogenic virulence factors.
2. For non-viable microorganisms, the inactivation method must also be described. As different inactivation methods and processes may affect cell membrane integrity, sponsors should take steps to ensure and demonstrate that cells remain intact and intact after inactivation.
3. Substances derived from or containing genetically modified organisms (GMO) are regulated by the Gene Technology Act and Gene Technology Regulations, which include regulation of import, manufacture, transportation, storage and disposal. The Gene Technology Regulatory Authority should be contacted early in the process of considering importing, manufacturing or supplying GMOs in therapeutic commodities.
4. For listed drug substances, additional manufacturing details should be provided as required for material control, critical steps and intermediate control, manufacturing process development, and manufacturing process validation and/or evaluation.

characterize

1. Genetic differences between strains of a species translate into the coding of different proteins; differences may be functional and have an impact on the safety and quality of the microorganism as an active ingredient. Evaluation of the characteristics of the strain should elucidate its identity, establish appropriate analytical tests, and identify impurities and incidental components.
2. For live microorganisms, characterization should also include detailed information on antimicrobial resistance and susceptibility profiles, and information addressing missing virulence factors, toxigenic and pathogenic properties.

General characteristics

1. Physicochemical properties: Information on physicochemical properties relevant to microbial characterization should be provided. Including: Appearance, Color, State, Texture, Odor, Solubility, Loss on Drying, Sulfate, pH, Micro and Macro Form etc.
2. Antimicrobial resistance and susceptibility:
   ．Therapeutic products containing live microorganisms as active ingredients should not increase the risk of transferring antibiotic resistance to the host. Antibiotics considered should be those relevant to human medicine use in Australia and classified as high, medium or low in importance by the Australian Antimicrobial Resistance Strategic and Technical Advisory Group (ATAG).
   ．Although antifungal drug resistance develops less rapidly than antibiotic resistance, therapeutics containing live microorganisms as active ingredients should not exert selective pressure on fungal resistance in the host.
3. Antibiotic resistance and susceptibility profiles
   ．Provide information to demonstrate antimicrobial resistance and susceptibility of anticipated proposed substances or RCMs containing live microorganisms as active ingredients.
   ．The application requirements for new substances in listed medicines should provide information on the physicochemical properties relevant to the microbiological characterization. Including appearance, color, state, texture, odor, solubility, loss on drying, sulfate, pH, micro and macro morphology, etc.
   ．For live microorganisms, characterization should also include detailed information on antimicrobial resistance and susceptibility profiles, and address missing virulence factors, toxigenic and pathogenic properties.
   ．For RCM, additional manufacturing details should be provided as outlined in the relevant section. Resistance to at least two commercially available antibiotics (e.g. ampicillin, streptomycin, erythromycin, clindamycin, tetracycline, chloramphenicol) as defined by ASTAG should be demonstrated Sensitivity to therapeutic concentrations.
   ．The minimum inhibitory concentration (MIC) should be determined using internationally recognized standard methods.
4. Antimicrobial resistance genes
   ．Where genomic data are available, in silico searches for antimicrobial resistance genes in at least two maintained databases are recommended to obtain a comprehensive understanding of relevant safety aspects of the live microorganisms being assessed. In silico analysis using a database capturing antimicrobial resistance genes from genome-wide datasets can identify any potential genetic resistance. In general, query sequences should be reported for at least 80% (at protein level or nucleotide level) and 70% length of the subject sequence hits.
5. Lack of horizontal drag transferability
   ．The endogenous microbiome in the host serves as a baseline defense against pathogens.
   ．Therefore, the horizontal transfer of genes encoding antimicrobial resistance to the host microbiome is undesirable. The genomes of live microorganisms to be assessed should be free of functional and transferable antimicrobial resistance genetic DNA that could convert to an antimicrobial resistance phenotype. When genomic data are available, searches for mobile or transposable genetic elements are required.
6. Absence of virulence factors
   ．Genes encoding known virulence factors (toxins, cell surface proteins that mediate microbe attachment, cell surface carbohydrates and proteins that protect microbes, hydrolases that may contribute to microbe pathogenicity, invasion and adhesion factors) should be searched for using the following methods Computational comparisons are performed in published databases, using the smallest available threshold for the coverage length in the database.
   ．If virulence factor genes are detected, details of any strain development strategies (including genetic engineering) aimed at reducing the virulence of the strain used should be provided. Where genomic data are available, in silico searches for antimicrobial resistance genes in at least two maintained databases are recommended to obtain a comprehensive picture of the relative safety of the live microorganisms being assessed.

Identity

1. For all microorganisms used as active ingredients, their genus, species and strain name/code/culture preservation number need to be identified.
2. Proteomic and phenotypic approaches: The phenotypic identification of microorganisms relies on morphological, physiological and biochemical properties that can yield different results. If the identity of the microorganisms being assessed is sufficiently established using genomic approaches, proteomic or phenotypic approaches are not required.

Determination

1. For live microorganisms used as substances in listed pharmaceuticals, assay tests provide validated specifications to determine the presence and amount (amount) of the microorganisms being evaluated. Counts or counts of individual microbial strains, expressed as colony forming units (CFU) or number of viable organisms, should be determined by an appropriate microbial enumeration test.
2. For non-viable microorganisms used as substances in listed drugs, express counts or counts of individual microbial strains in terms of the number of inactivated organisms using appropriate microbiological quality control tests. If counting or cell counting is performed prior to the inactivation step, the assay should be expressed as inactivated CFU as determined by an appropriate microbiological enumeration test.
   ．Impurities and Incidental Components: Impurities and Incidental Components are contaminants, components present in the microorganism as a by-product of production, or produced during the processing or storage of the microorganism.

Specification

1. Information such as description, characterization (identification, determination, impurity) analytical methods and acceptance criteria should be provided in the form of composition guidelines using the composition guidance template.
2. Information required to prove security
   ．Systematic literature search
   ．History and Patterns of Human Use
   ．Biological activity
   ．Toxicological data
   ．A list of the nature, severity and frequency of adverse reactions

Good Manufacturing Practice (GMP)

1. The basic principles of GMP are:
   ．Unable to perform quality inspection on a batch of products
   ．At all stages of the manufacturing process, quality must be built into each batch.
2. Overseas manufacturers supplying to Australia must also meet acceptable GMP standards.
3. If acceptable documentary GMP evidence cannot be provided, TGA will conduct on-site inspections in the same way as Australian manufacturers.
4. Any documents that are evidence of a GMP license application must be:
   ．An exact and complete copy of the original document. As an applicant, you are responsible for the authenticity of the documents provided, and heavily edited or changed documents will not be accepted.
   ．In English, or with an English translation by an independent certified translator.
   ．The latest and valid version.
5. Provide information
   ．Inspection reports from recognized regulatory agencies.
   ．Manufacturer’s name and address.
   ．latest certificate.
   ．The GLP certificate of the cooperative laboratory must be accredited by ISO.
   ．The scope of the inspection report covers the scope of application i.e. sterility, dosage form, drug substance, manufacturing steps and buildings covered.
   ．The time required for the inspection and the size of the inspection team are clearly documented in the report.
   ．Regulatory Checklist: A Site Master File (SMF) or equivalent is required as it provides information on the manufacturer’s operations, facilities and quality management system.
   ．List of products to be supplied: It is necessary to ensure that the substance or dosage form is within the scope of the application and provide the AUSSTR/AUSTL number.
   ．Ensure GMP, quality or technical agreements.
   ．Validation Master Plan (VMP).
   ．Other types of evidence: API declarations, etc.

【参考连结】
https://www.tga.gov.au/resources/resource/guidance/requirements-microorganism-characterisation-listed-medicines-and-registered-complementary-medicines
https://www.tga.gov.au/good-manufacturing-practice-overview

HLF-TW-75

HLF-TW-77

HLF-TW-80
外国子公司进口保健食品后，如果委託澳洲的经销商销售，经销商需要保健食品营业许可证吗？假如保健食品有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？

After a foreign subsidiary imports health food and entrusts a distributor in Australia to sell it, does the distributor need a health food business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
经销商无须营业许可证。

产品安全
1.最主要的责任为治疗用品登记册ARTG的负责人，负责需要确保补充药物的安全、品质。
2.当有不安全事件发生，製造商有责任进行安全警报、召回等配套措施。
3.ARTG负责人、经销商、製造商、进口商、零售商皆有责任监察补充药物的安全性，当发生不良事件时主动向TGA报告。

Dealers do not need a business license.

Product Safety
1.The main responsibility is the person in charge of the ARTG of the Therapeutic Goods Register, who is responsible for ensuring the safety and quality of supplementary medicines.
2.When an unsafe incident occurs, the manufacturer is responsible for safety alarms, recalls and other supporting measures.
3.The person in charge of ARTG, distributors, manufacturers, importers, and retailers are all responsible for monitoring the safety of supplementary drugs, and actively report to TGA when adverse events occur.

【参考连结】
https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-listed-medicines-and-registered-complementary-medicines
https://www.tga.gov.au/resources/resource/guidance/reporting-adverse-events

HLF-TW-85

各国健康食品登记法规问题集

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