澳洲保健食品登記法規問題集

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The Engaging Manager CA Lily Yan, 澳大利亞籍說中英文
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各國健康食品登記法規問題集

時間：2023/08/24 drafted by Yvonne Chen

HLF-TW-10
請問澳洲對於保健食品的歸類方式為何？它的正式名稱為何？不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？

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，保建食品被稱為補充藥物，由治療用品管理局 (TGA) 負責監管。當產品成分至少含有一種指定活性成分，則被視為補充藥物。

指定活性成分：
1.氨基酸
2.木炭
3.膽鹼鹽
4.精油
5.植物或草藥材料(或此類材料的合成替代品)
6.順勢療法製劑
7.完整或萃取的微生物(疫苗除外)
8.礦物質
9.黏多醣
10.非人類動物材料(或此類材料的合成替代品)
11.脂質
12.由蜜蜂產生或獲得的物質
13.糖、多醣或碳水化合物
14.維生素或維生素原

TGA採用兩級系統來評估補充藥物的風險：
1.風險較低的藥物可以列入澳洲治療用品登記冊( ARTG)。
2.風險較高的藥物必須在 ARTG 上註冊。

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.

【參考連結】
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
外國公司要到澳洲銷售保健食品，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？

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：
無營業特許證。
No business license.

【參考連結】
https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-listed-medicines-and-registered-complementary-medicines

HLF-TW-25
假如需要辦理，請問澳洲有專業服務公司可以協助辦理保健食品公司營業許可證？
Evershine RD：
無營業特許證。

HLF-TW-30
外國公司要到澳洲銷售保健食品，可以指派澳洲公司擔任營業代理人銷售嗎? 擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？

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，補充藥物須完成產品註冊即可銷售，營業代理人無須營業註冊。

產品安全
1.最主要的責任為治療用品登記冊ARTG的負責人，負責需要確保補充藥物的安全、品質。
2.當有不安全事件發生，製造商有責任進行安全警報、召回等配套措施。
3.ARTG負責人、經銷商、製造商、進口商、零售商皆有責任監察補充藥物的安全性，當發生不良事件時主動向TGA報告。

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.

【參考連結】
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
外國公司銷售到澳洲保健食品本身，進口前需要辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？保健食品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？

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：
須完成治療用品登記冊 (ARTG)註冊。

澳洲治療用品登記冊 (ARTG) 的列表或註冊號裡，AUST L或AUST R。L 代表上市，R 代表註冊。補充藥物註冊申請有五個級別(RCM 1 至 RCM 5)。每個級別都對應一個應用程序類別。與較高級別的申請相比，較低級別的申請需要較少的資料，費用較低且時間也較短。
分級

1. RCM 1
   ．必須在 ARTG 註冊並經過全面安全評估。
   ．標籤、適應症和配方必須充分標示。
   ．申請後TGA 可以檢核檔案和 ARTG 記錄的資料。
2. RCM 2
   ．安全性、品質和功效評估基於外國或外國司法管轄區主管監管機構的評估報告。
3. RCM 3
   ．針對的是仿製藥，不需要生物等效性數據來評估的藥物，或者已由 COB 評估，並需要 TGA 對以下其中一項進行獨立評估：藥物的安全性、品質、功效。
   ．RCM 3仿製藥補充藥物的條件：與經過充分評估的母藥相比，擬議的仿製藥必須具有相同的：活性成分的量、安全性和功效特性，以及母藥提供的安全性和有效性數據不得受到保護、藥物形式並被適當證明具有治療等效性。
4. RCM 4，註冊補充藥物的申請，其中滿足以下條件之一：
   ．申請已經過COB評估，需要TGA完成以下其中兩個評估：藥物的安全性、品質、功效。
   ．申請的是仿製藥，需要生物等效性數據來評價藥物。
   ．申請針對已註冊的藥物，且涉及以下一項或多項：藥物適應症的擴展、藥物使用的新方向、藥物目標人群的增加。
5. RCM 5，如果不是 RCM(1至 4)並且適用以下其中一項：
   ．需要對產品的安全性、品質和功效進行獨立評估
   ．該申請適用於已註冊的藥物，並且為：新劑型、一種新的活性、活性成分強、添加當時未在補充藥物中使用的。

註冊補充藥物評估的時間範圍和費用

1. RCM 1：初評通知工作日40天；評估時限45天。
2. RCM 2：初評通知工作日40天；評估時限90天。
3. RCM 3：初評通知工作日40天；評估時限150天。
4. RCM 4：初評通知工作日40天；評估時限180天。
5. RCM 5：初評通知工作日40天；評估時限210天。

註冊補充藥物所需的 資料

1. 一般要求
   ．英語：確保所有資料都是英文且可閱讀。對於非英文資料，請附上原始語言的副本、完整英文翻譯(如果需要幫助，可以通過國家筆譯、口譯認證機構(NAATI)網站尋找合格的譯員)。
   ．字體和可讀性：確保表格和圖像足夠大，並且即使在複印、掃描之後也能輕鬆閱讀，並且任何陰影都不會影響可讀性。建議文本不小於：12號字；表格內10號字；備註10號字。
   ．測量單位：使用公制單位。檢查檔案中的所有文件是否引用了SI單位2或澳洲臨床實踐中普遍接受的單位(例如毫米汞柱，或法國壓力表)的測量值。
   ．請求 (RFI)的回應：如果在評估您的檔案時要求提供更多資料，請確保符合一般檔案要求(可以接受最大40MB的電子郵件)。
   ．商業機密資料：無論是作為申請的一部分還是其他形式，都屬於商業機密。
   2.模組資料
   ．模組1：行政 資料和處方資料。
   ．模組2：品質、安全性和臨床數據摘要。
   ．模組3：品質。
   ．模組4：非臨床數據(安全性)。
   ．模組5：臨床數據(功效)。

申請流程

1. TGA 商業服務註冊、驗證
   註冊帳號 (Client ID)
   ．擔保人：擔保人必須是澳洲居民或澳洲的法人團體並有在澳洲開展業務，且公司代表居住在澳洲。
   ．詳細地址：街道、郊區/州、郵政編碼、郵寄地址、公司聯繫方式、賬單詳細訊息、電子郵件、電話、電子郵件。
   ．組織管理者：管理員全名(負責建立和維護組織的聯繫)、電子郵件、電話。
   ．澳洲代表：必須保留至少一名澳洲代表，境外代理商請指定您所在組織的澳洲代表作為授權聯繫人，需留存全名、電子郵件、電話。
   ．聲明。
   繳交：電子郵件交至 TGA TBS 服務台：ebs@health.gov.au
   產品註冊
   ．風險較高的藥物必須在澳洲治療產品登記冊 (ARTG)上註冊，其中涉及對產品的品質、安全性和有效性進行單獨評估。
   ．含有預先批准的低風險成分且聲明有限的低風險藥物可以在 (ARTG)上列出。
   產品註冊資料：標籤(包括標籤清單)、廣告、SPF 測試結果的再現性、穩定性測試、製造和品質控制、允許的成分、新成分。
   網頁：https://www.tga.gov.au/
2. 檢查成分
   ．繳交成分、專有成分資料。
   ．包含：澳洲批准名稱(化學物質)、草藥的植物學名稱(經批准的草藥名稱)、草藥成分名稱。
   ．透過電子郵件向TGA Names繳交相關資料
3. 確保有效的 GMP
   ．對於海外製造商，需具備TGA 頒發的GMP。
   ．如果海外製造商沒有當下有效的 GMP 許可(由 TGA 頒發)，就無法完成您的申請。所以需要確保GMP 許可在評估期限內不會過期。
4. 確定申請類別
   ．資料要求和評估時間範圍隨著分級所需的評估和風險增加，因此正確類別非常重要。
5. 檢查指南
   ．在計劃註冊補充藥物的申請時，需要確定並了解相關的技術和監管要求和指南。
6. 豁免申請
   ．如果符合豁免條件，則需要檢附豁免資料。
   7.編排數據
   ．將檢附的檔案依照標示編排。
   8.支付費用
   9.完成註冊

標籤
1.產品的標籤包括附在容器(例如：瓶子、管子、小袋等)和初級包裝(例如：紙箱)上的標籤。申辦者必須確保藥物隨附的產品標籤和任何印刷資料(例如：包裝說明書)符合所有相關法規(包括廣告)，然後才能在澳洲銷售。
2.圖形、徽章和符號：標籤上的非企業圖形、徽章或符號應與產品批准的詳細資料一致，包括產品聲稱的治療用途。
3.廣告、專業推薦、認可、贊助的聲明都必須符合治療用品廣告準則。
4.提及其他產品：在標籤中提及贊助商的其他產品是允許的，前提是這些產品包含在ARTG中(或豁免)。
5.無麩質或無糖之類的聲明必須屬實。
6.只有當網站上的資料(包括該網站的任何直接鏈接)與該產品的 ARTG 中包含的資料一致時，才可以在標籤上標示。
7.標籤說明：作為一般準則，新配方或現在等標籤說明不可用於描述已在澳洲上市和推廣超過12年的任何產品、介紹或治療適應症/聲明。
8.輔料成分：輔料成分不需要在藥物標籤上標示，除非是受限制的成分，例如：包含在毒物標準中。如果申辦者選擇在藥物標籤上披露一種(非強制性)輔料，則必須標示出所有的輔料。
9.所需的標籤必須以英語書寫。

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.

【參考連結】
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
外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？保健食品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？？網頁？

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，須完成治療用品登記冊 (ARTG)註冊。

澳洲治療用品登記冊 (ARTG) 的列表或註冊號裡，AUST L或AUST R。L 代表上市，R 代表註冊。補充藥物註冊申請有五個級別(RCM 1 至 RCM 5)。每個級別都對應一個應用程序類別。與較高級別的申請相比，較低級別的申請需要較少的資料，費用較低且時間也較短。
分級

1. RCM 1
   ．必須在 ARTG 註冊並經過全面安全評估。
   ．標籤、適應症和配方必須充分標示。
   ．申請後TGA 可以檢核檔案和 ARTG 記錄的資料。
2. RCM 2
   ．安全性、品質和功效評估基於外國或外國司法管轄區主管監管機構的評估報告。
3. RCM 3
   ．針對的是仿製藥，不需要生物等效性數據來評估的藥物，或者已由 COB 評估，並需要 TGA 對以下其中一項進行獨立評估：藥物的安全性、品質、功效。
   ．RCM 3仿製藥補充藥物的條件：與經過充分評估的母藥相比，擬議的仿製藥必須具有相同的：活性成分的量、安全性和功效特性，以及母藥提供的安全性和有效性數據不得受到保護、藥物形式並被適當證明具有治療等效性。
4. RCM 4，註冊補充藥物的申請，其中滿足以下條件之一：
   ．申請已經過COB評估，需要TGA完成以下其中兩個評估：藥物的安全性、品質、功效。
   ．申請的是仿製藥，需要生物等效性數據來評價藥物。
   ．申請針對已註冊的藥物，且涉及以下一項或多項：藥物適應症的擴展、藥物使用的新方向、藥物目標人群的增加。
5. RCM 5，如果不是 RCM(1至 4)並且適用以下其中一項：
   ．需要對產品的安全性、品質和功效進行獨立評估
   ．該申請適用於已註冊的藥物，並且為：新劑型、一種新的活性、活性成分強、添加當時未在補充藥物中使用的。

註冊補充藥物評估的時間範圍和費用

1. RCM 1：初評通知工作日40天；評估時限45天。
2. RCM 2：初評通知工作日40天；評估時限90天。
3. RCM 3：初評通知工作日40天；評估時限150天。
4. RCM 4：初評通知工作日40天；評估時限180天。
5. RCM 5：初評通知工作日40天；評估時限210天。

註冊補充藥物所需的 資料

1. 一般要求
   ．英語：確保所有資料都是英文且可閱讀。對於非英文資料，請附上原始語言的副本、完整英文翻譯(如果需要幫助，可以通過國家筆譯、口譯認證機構(NAATI)網站尋找合格的譯員)。
   ．字體和可讀性：確保表格和圖像足夠大，並且即使在複印、掃描之後也能輕鬆閱讀，並且任何陰影都不會影響可讀性。建議文本不小於：12號字；表格內10號字；備註10號字。
   ．測量單位：使用公制單位。檢查檔案中的所有文件是否引用了SI單位2或澳洲臨床實踐中普遍接受的單位(例如毫米汞柱，或法國壓力表)的測量值。
   ．請求 (RFI)的回應：如果在評估您的檔案時要求提供更多資料，請確保符合一般檔案要求(可以接受最大40MB的電子郵件)。
   ．商業機密資料：無論是作為申請的一部分還是其他形式，都屬於商業機密。
   2.模組資料
   ．模組1：行政 資料和處方資料。
   ．模組2：品質、安全性和臨床數據摘要。
   ．模組3：品質。
   ．模組4：非臨床數據(安全性)。
   ．模組5：臨床數據(功效)。

申請流程

1. TGA 商業服務註冊、驗證
   註冊帳號 (Client ID)
   ．擔保人：擔保人必須是澳洲居民或澳洲的法人團體並有在澳洲開展業務，且公司代表居住在澳洲。
   ．詳細地址：街道、郊區/州、郵政編碼、郵寄地址、公司聯繫方式、賬單詳細訊息、電子郵件、電話、電子郵件。
   ．組織管理者：管理員全名(負責建立和維護組織的聯繫)、電子郵件、電話。
   ．澳洲代表：必須保留至少一名澳洲代表，境外代理商請指定您所在組織的澳洲代表作為授權聯繫人，需留存全名、電子郵件、電話。
   ．聲明。
   繳交：電子郵件交至 TGA TBS 服務台：ebs@health.gov.au
   產品註冊
   ．風險較高的藥物必須在澳洲治療產品登記冊 (ARTG)上註冊，其中涉及對產品的品質、安全性和有效性進行單獨評估。
   ．含有預先批准的低風險成分且聲明有限的低風險藥物可以在 (ARTG)上列出。
   產品註冊資料：標籤(包括標籤清單)、廣告、SPF 測試結果的再現性、穩定性測試、製造和品質控制、允許的成分、新成分。
2. 檢查成分
   ．繳交成分、專有成分資料。
   ．包含：澳洲批准名稱(化學物質)、草藥的植物學名稱(經批准的草藥名稱)、草藥成分名稱。
   ．透過電子郵件向TGA Names繳交相關資料
3. 確保有效的 GMP
   ．對於海外製造商，需具備TGA 頒發的GMP。
   ．如果海外製造商沒有當下有效的 GMP 許可(由 TGA 頒發)，就無法完成您的申請。所以需要確保GMP 許可在評估期限內不會過期。
4. 確定申請類別
   ．資料要求和評估時間範圍隨著分級所需的評估和風險增加，因此正確類別非常重要。
5. 檢查指南
   ．在計劃註冊補充藥物的申請時，需要確定並了解相關的技術和監管要求和指南。
6. 豁免申請
   ．如果符合豁免條件，則需要檢附豁免資料。
   7.編排數據
   ．將檢附的檔案依照標示編排。
   8.支付費用
   9.完成註冊

標籤
1.產品的標籤包括附在容器(例如：瓶子、管子、小袋等)和初級包裝(例如：紙箱)上的標籤。申辦者必須確保藥物隨附的產品標籤和任何印刷資料(例如：包裝說明書)符合所有相關法規(包括廣告)，然後才能在澳洲銷售。
2.圖形、徽章和符號：標籤上的非企業圖形、徽章或符號應與產品批准的詳細資料一致，包括產品聲稱的治療用途。
3.廣告、專業推薦、認可、贊助的聲明都必須符合治療用品廣告準則。
4.提及其他產品：在標籤中提及贊助商的其他產品是允許的，前提是這些產品包含在ARTG中(或豁免)。
5.無麩質或無糖之類的聲明必須屬實。
6.只有當網站上的資料(包括該網站的任何直接鏈接)與該產品的 ARTG 中包含的資料一致時，才可以在標籤上標示。
7.標籤說明：作為一般準則，新配方或現在等標籤說明不可用於描述已在澳洲上市和推廣超過12年的任何產品、介紹或治療適應症/聲明。
8.輔料成分：輔料成分不需要在藥物標籤上標示，除非是受限制的成分，例如：包含在毒物標準中。如果申辦者選擇在藥物標籤上披露一種(非強制性)輔料，則必須標示出所有的輔料。
9.所需的標籤必須以英語書寫。

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.

【參考連結】
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
經過核准登記的保健食品，進口到澳洲要檢附什麼文件？經過什麼手續？在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？

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：
澳洲藥物管制辦公室 (ODC)規範麻醉藥物和精神藥物、前體物質以及合成代謝藥物和雄性激素藥物的進口商需申請進口許可證。如果沒有包含管制項目，則無需申請進口許可證。
1.網頁：https://www.odc.gov.au/importers
2.申請資料
．申請人詳細資料(主要許可證持有者)：姓名、職務、電話號碼、聯繫電子郵件。
．企業資料：公司/組織名稱、ABN/ACN、澳洲企業或公司編號、主要電子郵件地址、公司識別號、街道地址、郵寄地址、進出口原因、需要受控物質的目的。
．船務代理或報關代理：海關或貨運代理的公司的名稱、地址和提供的服務。
．持有的州/地區許可證：顯示每個此類許可證的全名、許可證號碼及其有效期。
．儲存與安全：提供受控物質的儲存、使用或供應場所的詳細資訊。場所的安全必須適合申請人將進口的物質和數量。
．最後一次安全報告的日期以及所在州/地區衛生部門官員最後一次進行安全檢查的日期。
．提供每類藥物(S4、S8、S9)運輸安全措施的詳細資訊，並說明由誰負責藥物運輸。
．授權聯繫人：許可證持有者可以指定人員代表其提交和討論進出口許可證申請。許可證持有者應說明作為授權聯繫人的每個人的全名和職位。
．聲明與同意
3.繳交申請
．紙本：藥物管制辦公室 麻醉品管制科
．電子郵件：NCS@health.gov.au

海關
進口流程

1. 執照和許可證：麻醉藥物和精神藥物、前體物質以及合成代謝藥物和雄性激素藥物的進口商需向澳洲藥物管制辦公室 (ODC)申請進口許可證。如果沒有包含管制項目，則無需申請進口許可證。
2. 估價：所有進入澳洲的進口商品都需要準確估價，以計算相關關稅、關稅、費用和稅費。交易價格以進口貨物的實際支付(或應付)價格為基礎，並作一定調整。海關在計算交易價值時使用貨物出口當天(而不是貨物到達澳洲當天)的匯率。
3. 稅費、關稅和收費
4. 標籤和說明：標籤需要符合規範，以英文標示並且容易閱讀。如果商品不符合標籤要求，可能會被扣押。
5. 進口報關(報關單分為三種)：價值超過1000 澳元的物品的進口報關單、通過空運或海運到達且價值低於 1000 澳元的物品的自評清關 (SAC)聲明、價值超過1000 澳元的清關前入庫物品的倉庫申報單(N20)。
   6.進口需要的資料
   ．貿易合約
   ．裝箱單
   ．商業發票
   ．提單
   ．原產地證明文件
   ．成分分析表等。

無銷售通知。

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.
【參考連結】
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
澳洲保健食品審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？

What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
微生物檢測
1.分類資料：提供微生物的分類訊息(包括屬、種類、菌株名稱/代碼/培養物保存編號)、培養物來源和生產方法。應提供批准的生物名稱(ABN)，否則必須提供有關命名申請的信件。 ．證明微生物作為活性成分的品質所需的訊息。
．注意強制性要求。
．列出申請的藥物。
．說明微生物是否源自或含有轉基因物質。
．如果該物質源自轉基因生物體，或者在製造過程中使用了轉基因生物體，請證明最終物質中不存在這種物質。
2如果該物質是經過基因改造的活微生物，請提供一份聲明，表明該生物體不受基因技術法規約束。

製造細節
1.製造過程和過程控制的描述
應使用藥典或其他經過驗證的程序提供有關培養物建立、培養物和培養基、儲存條件、孵化、批量大小的訊息。申請人須提供微生物的來源及其在菌株開發過程中的歷史(包括基因工程步驟)，以及基因工程步驟的一些實例，包括：抗生素抗性基因的插入或刪除、產毒和/或致病屬性的減少、表達病原體毒力因子的重組蛋白的使用。
2.對於非活性微生物，還必須描述滅活方法。由於不同的滅活方法和過程可能會影響細胞膜的完整性，申請人應採取措施確保並證明細胞在滅活後保持完整和完整。
3.源自或含有轉基因生物 (GMO)的物質受到基因技術法和基因技術條例的監管，其中包括對進口、製造、運輸、儲存和處置的監管。在考慮進口、製造或供應治療性商品中的轉基因生物的過程中，應該儘早聯繫基因技術監管機構。
4.對於所列藥物物質，應按照材料控制、關鍵步驟和中間體控制、製造工藝開發和製造工藝驗證和/或評估需提供其他製造詳細訊息。

表徵
1.一個物種的菌株與菌株之間的遺傳差異轉化為不同蛋白質的編碼；差異可能是功能性的，並對作為活性成分的微生物的安全性和品質產生影響。評估菌株的特徵應闡明其身份，建立合適的分析測試，並鑑定雜質和附帶成分。

2.對於活微生物，特徵描述還應包括抗菌素耐藥性和敏感性概況的詳細訊息，以及解決毒力因子、產毒和致病屬性缺失的訊息。

一般特性
1.理化性質：應提供與微生物表徵相關的物理化學特性的訊息。包括：外觀、顏色、狀態、質地、氣味、溶解度、乾燥失重、硫酸鹽、pH、微觀和宏觀形態等。
2.抗菌藥物耐藥性和敏感性：
．含有活微生物作為活性成分的治療產品不應增加將抗生素耐藥性轉移給宿主的風險。考慮的抗生素應是與澳洲人類藥物使用相關的抗生素，並由澳洲抗菌素耐藥性戰略和技術諮詢小組 (ATAG)根據重要性分類為高、中或低。
．儘管抗真菌藥物耐藥性的發展速度不如抗生素耐藥性，但含有活微生物作為活性成分的治療藥物不應對宿主的真菌耐藥性施加選擇性壓力。

3.抗生素耐藥性和敏感性概況
．提供訊息以證明含有活微生物作為活性成分的預期擬議物質或 RCM 的抗菌藥物耐藥性和敏感性。
．所列藥物中新物質的申請要求應提供與微生物表徵相關的物理化學特性的訊息。包括外觀、顏色、狀態、質地、氣味、溶解度、乾燥失重、硫酸鹽、pH、微觀和宏觀形態等。
．對於活微生物，特徵描述還應包括抗菌素耐藥性和敏感性概況的詳細訊息，以及解決毒力因子、產毒和致病屬性缺失的訊息。
．對於 RCM，應按照相關部分的概述提供其他製造細節應證明對 ASTAG 定義的至少兩種市售抗生素(例如氨芐青黴素、鏈黴素、紅黴素、克林黴素、四環素、氯黴素)的治療濃度的敏感性。
．應使用國際公認的標準方法確定最低抑菌濃度 (MIC)。
4.抗菌素耐藥基因
．在有基因組數據的情況下，建議在至少兩個維護的數據庫中對抗菌素耐藥性基因進行計算機搜索，以全面了解所評估的活微生物的相關安全性方面。使用從全基因組數據集中捕獲抗菌素耐藥基因的數據庫進行計算機分析，可以識別任何潛在的遺傳耐藥性。⼀般來說，應報告至少80%(在蛋白質水平或核苷酸水平)和 70%長度的主題序列命中的查詢序列。
5.缺乏水平阻力可轉移性
．宿主中的內源性微生物組充當針對病原體的基線防禦。
．因此，不希望將編碼抗微生物劑抗性的基因水平轉移至宿主微生物組。接受評估的活微生物的基因組應不含可轉化為抗菌素耐藥表型的功能性和可轉移抗菌素耐藥性基因 DNA。當基因組數據可用時，需要搜索移動或可轉座的遺傳元件。
6.不存在毒力因子
．應使用以下方法尋找編碼已知毒力因子(毒素、介導微生物附著的細胞表面蛋白質、保護微生物的細胞表面碳水化合物和蛋白質、可能導致微生物致病性的水解酶、入侵和黏附因子)的基因在已發布的數據庫中進行計算比較，用數據庫中覆蓋範圍長度的最⼩可用閾值。
．如果檢測到毒力因子基因，則應提供旨在降低所用菌株毒力的任何菌株開發策略(包括基因工程)的詳細訊息。在有基因組數據的情況下，建議在至少兩個維護的數據庫中對抗菌素耐藥性基因進行計算機搜索，以全面了解所評估的活微生物的相關安全性。

身分
1.對於作為活性成分的所有微生物，都需要鑑定其屬、種和菌株名稱/代碼/培養物保存編號。
2.蛋白質組學和表型方法：微生物的表型鑑定依賴於可能產生不同結果的形態學、生理學和生化特性。如果使用基因組方法充分確定了所評估的微生物的身份，則不需要蛋白質組學或表型方法。

測定
1.對於在所列藥物中用作物質的活微生物，化驗測試提供了經過驗證的規範，以確定所評估的微生物的存在和數量(含量)。單個微生物菌株的計數或計數，以菌落形成單位(CFU)或活生物體數量表示，應通過適當的微生物計數測試來確定。
2.對於在所列藥物中用作物質的非活性微生物，使用適當的微生物品質控制測試以滅活生物體數量來表達單個微生物菌株的計數或計數。如果在滅活步驟之前進行計數或細胞計數，則測定應表示為通過合適的微生物計數測試確定的滅活CFU。
．雜質和附帶成分：雜質和附帶成分是污染物、作為生產副產品存在於微生物中或者在微生物的加工或儲存期間產生的成分。

規格
1.應使用構圖指南模板以構圖指南的形式提供訊息，例如描述、表徵(鑑定、測定、雜質)分析方法和驗收標準。
2.證明安全所需的訊息
．系統文獻檢索
．人類使用的歷史和模式
．生物活性
．毒理學數據
．不良反應的性質、嚴重程度和頻率列表

良好生產規範 (GMP)
1.GMP的基本原則是：
．無法對一批產品進行品質檢驗
．在製造過程的所有階段，必須將品質融入到每批產品中。
2.向澳洲供應的海外製造商也必須符合可接受的 GMP 標準。
3.如果無法提供可接受的文件 GMP 證據，TGA 將以與澳洲製造商相同的方式進行現場檢查。
4.GMP許可申請證據的任何文件必須是：
．原始文件準確且完整的副本。作為申請人，須對所提供文件的真實性負責，不接受大量編輯或更改的文件。
．英文版，或附有獨立認證譯員的英文譯文。
．最新且有效的版本。
5.提供資料
．公認的監管機構的檢驗報告。
．製造商名稱及住址。
．最新的證書。
．合作實驗室的GLP證書須獲得ISO認可。
．檢驗報告的範圍涵蓋應用範圍，即無菌、劑型、原料藥、生產步驟和所涵蓋的建築物。
．報告中清楚記錄了檢查所需的時間和檢查團隊的規模。
．監管檢查清單：需要現場主文件(SMF)或同等文件，因為它提供有關製造商運營、設施和品質管理體系的資訊。
．擬供應產品清單：須確保物質或劑型在申請範圍內、提供AUSTR/AUSTL編號。
．確保GMP、品質或技術協議。
．驗證總體計劃(VMP)。
．其他類型的證據：API聲明等。

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.

【參考連結】
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
外國子公司進口保健食品後，如果委託澳洲的經銷商銷售，經銷商需要保健食品營業許可證嗎？假如保健食品有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？

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：
經銷商無須營業許可證。

產品安全
1.最主要的責任為治療用品登記冊ARTG的負責人，負責需要確保補充藥物的安全、品質。
2.當有不安全事件發生，製造商有責任進行安全警報、召回等配套措施。
3.ARTG負責人、經銷商、製造商、進口商、零售商皆有責任監察補充藥物的安全性，當發生不良事件時主動向TGA報告。

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.

【參考連結】
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

各國健康食品登記法規問題集

聯繫人：
Email：mel4ww@evershinecpa.com
或
澳洲永輝BPO有限公司
Melbourne time zone:
The Engaging Manager CA Lily Yan, 澳大利亞籍說中英文
或
China Time Zone:
聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
Mobile: +886-933920199 in Taiwan; Mobile: +86-139-1048-6278 in China
TEL: +886-2-27170515 E100 ;
Wechat id:evershiinecpa;
Line Id: evershinecpa
Skype: daleccchen ;
linkedin address:Dale Chen Linkedin
全球永輝服務據點參考資料:
永輝100%關係企業
永輝總部、臺北永輝、廈門永輝、北京永輝、上海那靈、深圳常新、紐約永輝、加州永輝、德州永輝、鳳凰城永輝、東京永輝、首爾永輝、河內永輝、越南胡志明、曼谷永輝、新加坡永輝、吉隆玻永輝、雅加達永輝、馬尼拉永輝、墨爾本永輝、澳洲雪梨、孟加拉永輝、新德里永輝、印度孟買、杜拜永輝、法蘭克福永輝、巴黎永輝、倫敦永輝、荷蘭永輝、西班牙永輝、義大利永輝、羅馬尼亞永輝、多倫多永輝、墨西哥永輝。
其他已提供中文化服務城市：
邁阿密、亞特蘭大、俄克拉荷馬、密歇根、西雅圖、特拉華；
柏林; 斯圖加特;布拉格；布加勒斯特；班加羅爾；泗水；
高雄、香港、深圳、東關、廣州、清遠、永康、杭州、蘇州、崑山、南京、重慶、許昌、青島、天津。
永輝潛在可服務城市 (2個月籌備期)：
我們為IAPA會員所,總部在倫敦，全球300個會員所，員工約1萬人。
我們為LEA會員所,總部在美國芝加哥，全球600個會員所，員工約2萬8千人。
Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)
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