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therapeutic good administration -回复什么是治疗性产品管理（Therapeutic Goods Administration）？治疗性产品管理（Therapeutic Goods Administration，TGA）是澳大利亚联邦政府负责监管医药和医疗器械的机构。
TGA的主要职责是确保澳大利亚市场上销售的治疗性产品的安全性、质量和有效性。
该机构授权对药物、医疗器械、生物制品和诊断用品进行监管，并负责对其进行注册、批准和监督。
TGA的组织结构和职责TGA是澳大利亚卫生部的一个中央监管机构，负责医疗、药品和生物制品的监管。
TGA的组织架构包括多个分支，其中包括处方药部门、非处方药部门、注册部门、设备评估部门、监控部门和合规部门。
每个部门都有具体的职责和监管范围。
处方药部门负责监管处方药品，确保其安全、质量和有效性。
他们负责审查药物的注册申请，并审批药物的上市销售。
他们还负责监控药物的安全性和有效性，收集和分析药物的副作用信息。
非处方药部门负责监管非处方药品，也被称为成人用品或常规医疗用品。
他们负责确定哪些药品可以以非处方形式销售，并确保其安全和适当使用。
注册部门负责管理通用药物和生物制品的注册。
他们负责审核药物、生物制品和植入物的注册申请，并核准其上市销售。
他们还负责监督已注册产品的质量和安全性。
设备评估部门负责审核和批准医疗器械、植入物和诊断工具的注册申请，并确保其安全和质量。
他们负责监督已注册的设备，并处理设备的质量投诉和安全问题。
监控部门负责监测澳大利亚市场上所有治疗性产品的安全性和有效性。
他们负责接收和评估关于产品安全性的信息，并采取必要的行动来保护公众的健康和安全。
合规部门负责监督和管理澳大利亚境内治疗性产品生产和销售的合规性。
他们负责对生产和供应商进行审核，并确保其符合澳大利亚的法律法规和标准。
他们还负责制定政策和准则，以指导业界合规操作。
TGA的监管流程TGA的监管流程包括产品注册和批准、安全监测和风险管理、市场监督和合规性审核。
过海关药品申报流程一、前言。
出国旅行或者从国外回来的时候，药品申报是过海关时很重要的一个环节。
如果处理不好，可能会耽误行程，甚至药品还会被没收呢。
下面就给大家详细说说过海关药品申报的流程。
二、准备工作。
1. 了解规定。
- 在出发之前，要先去了解目的地国家和本国海关关于药品的规定。
不同国家对药品的管制可是大不相同的。
比如说，有些国家对含有某些成分（像麻黄碱之类的）的药品管控得非常严格。
可以通过海关官网查询，或者打电话咨询海关工作人员。
2. 整理药品清单。
- 把要携带的药品都找出来，列一个清单。
清单上要写清楚药品的名称（最好是中英文都写，如果有药品的通用名就更好了）、数量、用途。
例如：“感冒清热颗粒，3盒，用于治疗感冒”。
- 对于一些特殊药品，像处方药，一定要带上医生的处方。
处方最好是原件，如果是复印件也要确保清晰，上面有医生的签名、医院的盖章，能清楚地显示药品的名称、用量等信息。
三、申报流程。
1. 填写申报单。
- 在飞机上或者到达海关之前，会拿到海关申报单。
在申报单上找到关于药品申报的部分。
如果是英文的申报单，常见的表述可能是“Medications”或者“Drugs”。
- 根据自己携带药品的实际情况在申报单上填写。
如果是少量自用的非处方药，一般就按照正常的填写方式，把药品名称和数量写上。
如果是处方药，除了写名称和数量，可能还需要在旁边注明“Prescription drugs with doctor's prescription”（有医生处方的处方药）。
2. 到达海关检查处。
- 下飞机后，跟着人流走到海关检查区域。
- 把填写好的申报单、护照还有药品清单（如果有准备的话）拿在手上，方便海关工作人员检查。
3. 接受海关询问。
- 海关工作人员可能会问一些关于药品的问题，这时候不要紧张，如实回答就好。
- 他们可能会问：“What are these medications for?”（这些药是用来做什么的？）你就可以回答：“For my headache/flu, etc.”（用于治疗我的头痛/流感等）。
澳洲保健品物料标准
在澳洲，保健品的物料标准主要由澳大利亚治疗商品管理局（TGA）负责监管。
TGA对保健品物料进行严格的审查和监管，以确保其安全性和有效性。
澳洲保健品的物料标准包括以下方面：
1. 成分标准：TGA要求保健品的成分必须在正确的剂量和比例下使用。
所有的成分必须经过合理的科学研究支持其功效，并且不得含有任何禁用的或有害的物质。
2. 质量控制：保健品必须符合TGA制定的质量控制要求，包括原材料的质量和规范、生产过程的控制、产品的稳定性和质量测试等。
3. 标签要求：保健品的标签必须清晰明确地列出产品的成分、用法和用量、禁用的人群和注意事项等信息。
标签必须符合TGA的规定，并且不得进行虚假宣传或误导性表述。
4. 安全性评估：TGA要求保健品的制造商必须进行全面的安全性评估，并报告任何与产品使用相关的不良反应。
5. 追溯与召回：在澳洲市场上销售的保健品必须能够追溯到其生产和分销渠道。
如果发现产品存在安全问题或不合规问题，TGA有权要求制造商进行产品召回或下架。
总之，澳洲保健品的物料标准旨在确保产品的安全性、有效性和质量，并提供准确的产品信息给消费者。
制造商必须遵守这些标准才能在澳洲市场上销售保健品。
TGA安装操作培训TGA（Therapeutic Goods Administration）是澳大利亚药品和医疗器械管理局的缩写。
它是一个负责监管和管理药品、医疗器械和其他健康产品的机构。
安装TGA系统是非常重要的，它可以帮助企业管理和监控医药产品的生产、销售和使用。
以下是TGA安装操作培训的内容，具体涵盖了如何进行TGA系统的安装、操作和管理。
第一步：系统前期准备在安装TGA系统之前，我们需要进行一些前期准备工作。
首先，我们需要了解TGA系统的功能和用途，并了解其适用范围。
其次，我们需要对企业的具体需求进行分析和评估，以确定系统的规模和功能要求。
最后，我们还需与TGA系统供应商进行沟通和协商，以确保系统的定制和配置符合企业的需求。
第二步：系统安装系统安装是整个过程中最重要的一步。
首先，我们需要进行硬件设备的选择和布置。
这包括服务器、网络设备和终端设备等。
其次，我们需要安装TGA系统的软件。
这通常需要将安装程序拷贝到服务器上，并按照安装程序的指导进行安装。
安装完成后，我们还需要进行系统的基本配置，包括数据库连接、用户权限设置和系统参数调整等。
第三步：系统配置系统配置是根据企业需求对TGA系统进行参数配置和功能定制的过程。
首先，我们需要根据企业的组织结构和岗位设置，建立相应的用户权限和角色。
其次，我们需要根据企业的产品分类和注册要求，设置相应的产品分类和注册流程。
此外，我们还需要进行系统的数据字典配置，包括字段名称、数据类型和数据范围等。
第四步：数据导入数据导入是将企业现有的数据导入到TGA系统中的过程。
首先，我们需要对企业现有的数据进行整理和处理，以确保数据的准确性和完整性。
然后，我们需要将数据转换成TGA系统所需的格式，并进行数据导入。
在数据导入过程中，我们还需要进行数据验证和调整，以确保数据的一致性和正确性。
第五步：系统测试系统测试是验证TGA系统是否满足需求和预期效果的过程。
在系统测试过程中，我们需要进行功能测试、性能测试和安全性测试等。
therapeutic good administration -回复以下是一篇关于治疗产品管理（Therapeutic Goods Administration）的1500-2000字文章。
本文一步一步回答了有关该主题的问题。
第一部分：什么是治疗产品管理（Therapeutic Goods Administration）？治疗产品管理（TGA）是澳大利亚政府的一个机构，负责监管和管理用于人类和动物的治疗产品，以确保其安全、有效和高质量。
TGA是澳大利亚联邦政府卫生部门的一部分，其目标是保护公众免受不安全或低质量治疗产品的伤害，并提供可靠、有效和合规的治疗选择。
第二部分：TGA的职责是什么？TGA的主要职责是确保澳大利亚市场上的治疗产品符合法规要求。
其职责包括但不限于以下方面：1. 注册和评估：TGA负责注册和评估治疗产品。
在治疗产品上市之前，必须通过TGA的评估程序，以确保其质量、安全性和疗效。
2. 监管和许可：TGA对制药公司和生产商进行监管，以确保其符合适用的法规和标准。
TGA还颁发许可证给制药商，允许他们在澳大利亚销售和推广治疗产品。
3. 监控和追踪：TGA负责监控澳大利亚市场上的治疗产品，并追踪任何与其安全性相关的问题或不良事件。
他们还负责发布有关治疗产品安全的警告，并与制药公司合作，确保他们采取适当的措施来解决任何问题。
4. 信息提供：TGA为公众、从业人员和其他利益相关者提供关于治疗产品的信息和教育。
他们的网站上提供了疾病治疗指南、药品数据库以及有关治疗产品监管和管理的准则。
第三部分：TGA如何管理治疗产品？TGA通过一系列操作和程序来进行治疗产品的管理。
以下是TGA管理治疗产品的主要步骤：1. 注册和评估：制药公司需要向TGA提交治疗产品的注册申请。
TGA将评估该申请，确保产品符合质量、安全和疗效标准。
他们会考虑制药公司提供的测试数据和临床试验结果，以及产品的制造、成分和使用说明等信息。
澳门新药上市审评审批流程下载温馨提示:该文档是我店铺精心编制而成，希望大家下载以后，能够帮助大家解决实际的问题。
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澳大利亚农药兽药管理局（APVMA）发布的农药药效和作物安全性试验指导对申请农药登记进行的田间药效试验提出了非常详细的要求。
了解这些要求对于申请澳大利亚农药制剂登记、变更登记或者申请小宗作物使用许可等具有重要指导作用。
它详述了与药效试验及作物安全性试验有关的各方面内容，包括试验地和试验作物的选择、试验次数、试验方法、剂量、抗性预防措施的确定，农药对靶标作物、后茬作物以及非靶标作物的安全性，以及在某些特定情形下如何利用非试验数据满足药效标准要求等。
本文对中国新创制农药产品进军澳大利亚市场提供参考。
澳大利亚农药药效试验指导是参照欧美等发达国家的相关标准制定的，具有先进性，这对于中国农药药效试验也有借鉴意义。
1 药效和作物安全性试验指导的应用范围欲注册农药制剂产品、变更登记要素或登记条件的，或欲持有农药制剂使用许可证的申请人，均须确保该产品符合农药兽药法（Agvet Code）规定的药效标准（Efficacy cri-teria）。
药效和作物安全性试验指导适用于如下情形：（1）申请登记含有新活性成分或现有活性成分的农药制剂产品；（2）申请变更已登记的农药制剂产品的登记要素或登记条件，例如变更使用模式或对制剂配方进行重要变更；（3）申请批准“小宗作物”用的农药制剂产品的许可证。
某些产品在提交申请时可能不需要药效数据、证据或参考产品的用途等信息来满足药效标准要求。
2 满足药效标准要求的途径农药药效及其对作物的安全性资料必须能够证明当产品按照标签说明使用时能够产生标签声明的药效，并且对靶标作物（或其他使用场合）不造成任何不良影响。
APVMA的农药药效试验原则与美国环境保护署（EPA）、加拿大害物管理署（PMRA）、英国环境、食品和农村事务部的农药安全理事会（PSD）、英国卫生和安全执行局（HSE）的杀生剂和农药处，以及欧洲和地中海植物保护组织（EPPO）等组织制订的相关原则一致。
满足农药制剂产品药效和作物安全性标准要求的途径之一是提交正确设计和实施的实验室和/或田间试验的结果，以证明该产品的药效和作物安全性。
澳洲医疗器械质量管理体系法规指南随着医疗科技的发展和医疗水平的提高，医疗器械的质量安全问题越来越受到人们的关注。
澳洲作为一个医疗科研发达的国家，其医疗器械质量管理体系的法规指南十分完善，对医疗器械的生产、销售、使用都有着详细的规定。
本文将为大家详细介绍澳洲医疗器械质量管理体系的法规指南，帮助大家更好地了解澳洲医疗器械的质量管理情况。
一、澳洲医疗器械管理局（TGA）是澳洲负责医疗器械管理的官方机构，其主要职责包括：1. 制定医疗器械法规和管理制度，确保医疗器械的质量和安全；2. 对医疗器械的生产、销售、使用等环节进行监管，提供相关指导和支持；3. 批准和注册医疗器械，进行评估和监督。
二、澳洲医疗器械质量管理体系的法规内容主要包括：1. 医疗器械注册制度：所有在澳洲销售和使用的医疗器械都必须经过TGA的注册和批准，确保其符合相关的质量和安全标准。
2. 医疗器械分类管理：根据医疗器械的风险等级进行分类管理，并对不同等级的医疗器械制定相应的管理要求。
3. 医疗器械生产管理：对医疗器械的生产企业进行认证和监督，确保其生产过程符合质量管理体系的要求。
4. 医疗器械标识和说明书管理：所有医疗器械必须标注清晰的产品信息和使用说明，确保患者和医护人员正确使用。
5. 医疗器械进口管理：对进口的医疗器械进行注册和监管，确保其质量和安全符合澳洲标准。
三、澳洲医疗器械质量管理体系的法规指南对医疗器械的质量管理提出了严格的要求，对澳洲医疗器械市场的健康和可持续发展起到了重要的保障作用。
也为其他国家的医疗器械管理提供了宝贵的借鉴和参考。
四、在实际操作中，企业和医疗机构需要严格遵守澳洲医疗器械质量管理体系的法规要求，加强对医疗器械生产和使用过程中的管理和监督，提高医疗器械的质量和安全水平。
也需要加强对医护人员和患者的培训和宣传，促进正确使用医疗器械，减少医疗事故的发生。
澳洲医疗器械质量管理体系的法规指南为医疗器械的质量和安全提供了坚实的保障，对于提高患者的治疗效果和保障医疗安全起到了重要的作用。
Access to Unapproved Therapeutic Goods - Authorised PrescribersOctober 2004INDEXThese guidelines4Introduction 6 The legal basis for supply of unapproved therapeutic goods 6 Promotion of unapproved therapeutic goods 8 Release of information 8Basic principles governing the supply of unapproved products using the Authorised Prescriber mechanism10 Patient rights10 Responsibilities of the prescriber10 Responsibilities of the TGA11 Rights and responsibilities of the sponsoring company (supplier)11 Conditions of Authorisation12 Other12 The TGA's attitude toward existing Section 19(5)/41HC Authorisations when another product is registered for treatment of the specific condition13 How to become an Authorised Prescriber14 Who can become an Authorised Prescriber?14 Requesting an authorisation from TGA - the overall approach14 The criteria used by delegates in deciding whether to give Authorisation14 How TGA balances the criteria17 The role of the ethics committee19 Information required by the ethics committee when consideringendorsement of a medical practitioner as an Authorised Prescriber19 Conditions may be imposed on the endorsement by an ethics committee19 An ethics committee can withdraw its endorsement20 Circumstances under which TGA may revoke an Authorisation20How to obtain an unapproved medicine or medical device once Authorisation has been granted21 Products available in Australia21 Products not available in Australia21 Reporting of adverse outcomes associated with the use of unapproved therapeutic goods23 Definitions23 Responsibilities for reporting25 What should be reported and how25What to do if your application to become an Authorised Prescriber is rejected29 Informal mechanisms29 Formal appeal mechanisms29 Decisions under the Customs Act30 AppendicesAppendix 1General conditions of an Authorisation under Section 19(5)/41HC Appendix 2'Agreement to Treatment Directions' formAppendix 3Consent to Treatment and Indemnity for Use of Products Derivedfrom Human Blood or PlasmaAppendix 4HREC Letter of endorsement for Authorised PrescribersAppendix 5ADRAC 'blue card' for reporting adverse medicine reactionsAppendix 6Medical Device Incident ReportThese guidelines·This document updates Access to Unapproved Therapeutic Goods – Authorised Prescribers May 2001The changes to this document accommodate the introduction of Australia’s new regulatory system for medical devices in October 2002. The changes to Australia’s regulatory system for medical devices have been effected through amendment of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations 1990 (the Regulations), and through the creation of a separate set of regulations specifically for medical devices - Therapeutic Goods (Medical Devices) Regulations 2002 (the Medical Device Regulations).The range of mechanisms for access to unapproved therapeutic goods remains the same following the implementation of the new medical device regulatory system, and the operation of the Authorised Prescriber mechanism is unchanged.NOTE: The Act has been substantially restructured and is now divided into ‘chapters’, rather than ‘parts’.The requirement for products to be entered into the ARTG has been retained. However, whereas in the past all therapeutic goods were treated the same in terms of ARTG registration or listing requirements (previously Part 3 of the Act) and manufacturing requirements (previously Part 4 of the Act), there are now separate chapters dealing with medicines (chapter 3) and medical devices (chapter 4). These chapters contain quite distinct differences in the approach to the inclusion of these products on the ARTG. Chapter 3 also captures a third set of goods, which are now known as ‘other therapeutic goods’ (OTGs). These are goods previously regulated as devices but which no longer satisfy the revised definition of a medical device. These products include tampons and household and hospital grade disinfectants.Medicines and ‘other therapeutic goods’ continue to be regulated as either ‘registrable’ or ‘listable’ goods, with the same TGA pre-market evaluation and manufacturer licensing requirements and procedures as previously (Sections 25, 26, 35 and 36 of the Act). The particular requirements for medical devices and the administrative processes and enforcement procedures principally aimed at ensuring those requirements are met are outlined in Chapter 4.At the time of introduction of the new regulatory system for devices, the legislation was framed such that, pursuant to s15A, existing mechanisms for access to unapproved medical devices provided under sections18 and 19 of the Act continued to be operational for a period of 2 years. From October 2004, allmechanisms of access to unapproved medical devices will operate through the provisions set out in Chapter 4.Importantly, the new regulatory framework for medical devices excludes in-vitro diagnostic devices (IVDs), devices of human origin and devices containing viable cells or tissue of animal origin. Although these products fit the definition of a medical device, they have been excluded because the Australian Government is committed to developing new regulatory frameworks for them. In the interim period these products will be regulated as per the previous system, as ‘other therapeutic goods’.·This publication describes how medical practitioners can obtain approval as an 'Authorised Prescriber' for the purpose of supplying an unapproved therapeutic good (medicine, ‘other therapeutic goods’ or medical device) under Section 19(5) and Section 41HC of the Therapeutic Goods Act, 1989, and their obligations arising from such authorisations.·These guidelines are one in a series of documents developed by the Therapeutic Goods Administration (TGA) about the mechanisms to obtain access to unapproved therapeutic goods in Australia. The publications in this series include:·Access to Unapproved Therapeutic Goods - Authorised Prescribers (this publication);·Access to Unapproved Therapeutic Goods - Clinical Trials in Australia;·Access to Unapproved Therapeutic Goods via the Special Access Scheme; and·Access to Unapproved Therapeutic Goods via Personal Importation.The TGA has also developed a publication Access to Unapproved Therapeutic Goods in Australia which is a consolidation of all the documents in the series. This should be consulted if you are unsure which is the appropriate mechanism to use.Abbreviations and AcronymsADRAC Adverse Drug Reactions Advisory CommitteeAGRD Australian Guidelines for the Registration of DrugsARTG Australian Register of Therapeutic GoodsC(PI) Regulations Customs (Prohibited Imports) Regulations 1956CTN Clinical Trial Notification (Scheme)CTX Clinical Trial Exemption (Scheme)DSEB Drug Safety and Evaluation Branch, TGAHREC Human Research Ethics CommitteeICH International Conference on Harmonisation (of TechnicalRequirements for Registration of Pharmaceuticals for HumanUse)ODBT Office of Devices, Blood and Tissues, TGAOTGs‘other therapeutic goods’SAS Special Access Schemethe Act Therapeutic Goods Act 1989TGA Therapeutic Goods Administrationthe Regulations Therapeutic Goods Regulations 1990the Medical DevicesTherapeutic Goods (Medical Devices) Regulations 2002RegulationsINTRODUCTIONThe major legislation dealing with the regulation of therapeutic goods in Australia is the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations 1990 (the Regulations) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the Medical Devices Regulations). One important outcome of this legislation is that most therapeutic goods are required to be approved and included on the Australian Register of Therapeutic Goods before they can be supplied unless there is an exemption. The legislation provides a number of mechanisms for exemption which allows access to therapeutic goods that have not been approved and included on the Australian Register of Therapeutic Goods.The Legal Basis for Supply of Unapproved Therapeutic GoodsThe Therapeutic Goods Act, 1989 and associated regulations establishes a uniform, national system of regulatory controls to ensure the quality, safety, efficacy and timely availability of therapeutic goods for human use. Responsibility for the regulatory controls lies with the Therapeutic Goods Administration (TGA) as the national regulatory authority for therapeutic goods.Overall control of the supply of therapeutic goods is exerted through three main processes:·the pre-market evaluation and approval of products intended for supply in Australia;·the licensing of pharmaceutical manufacturers and certification of device manufacturer quality systems; and·post market surveillance.Under the Act, therapeutic goods for human use that are imported, manufactured in Australia, supplied by a corporation, supplied interstate or to the Commonwealth, or exported must be included in the Australian Register of Therapeutic Goods (ARTG) unless specifically exempted by the Act.Some therapeutic goods are exempted under the Act from the requirement for inclusion in the ARTG before they can be supplied. These exemptions are set out in for medicines and ‘other therapeutic goods’ (OTGs) in Chapter 3 Section 18 and Section 19 and for medical devices in Chapter 4 Part 4-7. The regulations relevant to these sections are:·Schedule 5 (Regulation 12(1)), Schedule 5A (Regulation 12(1A)) and Regulation 12A of the Regulations for medicines and OTGs; and·Regulations 7.1-7.7 and Schedule 4 (Regulation 7.1) of the Medical Devices Regulations for medical devices.The legislation provides the following mechanisms that allow individuals to gain limited access to therapeutic goods not on the ARTG:·The Special Access Scheme (categories A and B);·Clinical Trials (CTN and CTX schemes);·Authorised Prescribers; and·Importation for personal use.The figures below provide a graphic representation of these mechanisms and the sections of the Act and regulations relevant to their operation. The provisions specifically relating to the Special Access Scheme have been shaded.Figure 1Access to unapproved medicines and OTGsUse in Clinical Trial Personal ImportationSubsection 18(1)Reg 12(1)Schedule 5 item 1Special AccessSchemeAuthorised PrescriberSubsection 19(5)Subsection 31B(3)Reg 12BCTN Subsec 18(1) Subsec 31A(1) Reg 12 & Schedule 5A,item 3CTXSection 19,esp 19(1)(b)Subsec 31B(1)& 31B(2)Regs 12AA-12ADCategory ASection 18Subsec 31A(2)Reg 12ACategory BSection 19, esp19(1)(a)*Subsec 31B(1)TGAofficersAuthorisedby externaldelegateSubsec 57(3)Reg 47A* Section 19 (1)(a) allows supply for Category A and Category B patients but, in practice, category A cases are dealt with under s18 and reg12A.Reg = Therapeutic Goods Regulations 1990Figure 2Access to unapproved medical devicesUse in Clinical Trial Personal ImportationSection 41HAMDReg 7.1 &Schedule 4 item 1.1Special AccessSchemeAuthorised PrescriberSection 41HCSection 41JFMDReg 7.6, 7.7CTN Section 41HA Subsec 41JD(1) MDReg 7.1 & Schedule 4,item 2.3CTXSection 41HBSection 41JEMDRegs 7.3-7.5Category ASection 41HASection 41JDMDReg 7.2MDReg 8.2Category BSection 41HBSubsec 41JE (1)TGAofficersAuthorisedby externaldelegateSubsec 57(3)MDReg 10.6MDReg = Therapeutic Goods (Medical Devices) Regulations 2002A full copy of the legislation can be found on the TGA Website:http://www/.au/legis/index.htmUnder subsections 19(5)-(9) and Section 41HC of the Act, the TGA is able to grant certain medical practitioners authority to prescribe a specified unapproved therapeutic good or class of unapproved therapeutic goods to specified recipients or classes of recipients (identified by their medical condition). The medical practitioner becomes an 'Authorised Prescriber' and can prescribe that product for that condition (also known as the 'indication') to individual patients in their immediate care without further approval from the TGA.The authorisation extends only so far as to allow the Authorised Prescriber to supply the product directly to specified patients and not to other practitioners who prescribe/administer the product to patients. There is no power under Sections 19(5) or 41HC of the Act to authorise the medical practitioner to supply product to parties other than the specified class of patient.The basis for providing Section 19(5)/41HC approvals is that the authorised medical practitioner has training and expertise appropriate for the condition being treated and the proposed use of the product and that the Authorised Prescriber is able to best determine the needs of the patient and to monitor the outcome of therapy.Promotion of Unapproved Therapeutic GoodsThe promotion of unapproved therapeutic goods is an offence under subsection 22(6) of Chapter 3 (medicines) and section 41MM of Chapter 4 (medical devices) of the Act and carries a financial penalty. A person must not intentionally or recklessly make a claim, by any means, that the person or another person can arrange the supply of unapproved therapeutic goods.R elease of InformationI nformation provided to the TGA concerning the use of unapproved therapeutic goods will be treated as confidential within the constraints of Section 61 of the Therapeutic Goods Act 1989 which prescribes certain circumstances in which information may be released.T he Freedom of Information Act 1982 (FOl Act) also governs access to information. Section 27 of the FOI Act requires that consultation occur between the TGA and the owner of the information prior to release of that documentation.I n addition, the Privacy Act 1988 places limits on the disclosure of personal information by parties in possession or control of records. Such parties cannot disclose personal information about an individual to a person, body or agency other than the individual concerned except under certain circumstances. These circumstances include situations where:·the individual concerned has consented to the disclosure or is reasonably likely to have been aware that information of that kind is usually passed to that person, body or agency;·the holder of the record has reasonable grounds to believe that disclosure is necessary to prevent or lessen a serious, imminent threat to life or health of the individual concerned;·the disclosure is required or authorised by or under law; or·the disclosure is reasonably necessary for the enforcement of criminal law or of a law imposing criminal penalty, or for the protection of the public revenue.Therefore information supplied to the TGA may be released in circumstances consistent with the Privacy and FOI legislation.Under the Therapeutic Goods Act 1989, the TGA is able to release information concerning the use of unapproved therapeutic goods to State and Territory authorities, which have a need to know. This allows States and Territories to have information to take action on matters under their jurisdiction, such as medical or pharmacy practice. The circumstances under which this may occur include, but are not limited to, the TGA becoming aware that a medical practitioner is using notification mechanisms (eg Category A SAS or the CTN Scheme) inappropriately so as to avoid having to obtain approval from the TGA for supply of an unapproved therapeutic good or where audit of use of unapproved products establishes issues of negligent or unprofessional behaviour.Doctors and sponsors reporting adverse events associated with use of unapproved products to the TGA should be familiar with and discharge obligations in relation to the collection, use and disclosure of personal information in accordance with the National Privacy Principles based on the Privacy Act 1988. These obligations are set out in the Guidelines on Privacy in the Private Health Sector, Office of the Federal Privacy Commissioner, November 2001. The TGA’s requirement for applicants to provide information on an identifiable patient does not override these privacy principles and explicit consent to the disclosure of the patient’s identity to TGA must be sought.BASIC PRINCIPLES GOVERNING THE SUPPLY OF UNAPPROVED PRODUCTS USING THE AUTHORISED PRESCRIBER MECHANISMPatient rightsRight of accessThe Authorised Prescriber provisions of the legislation allows doctors to supply individual patients with unapproved therapeutic goods under a range of circumstances such as:·access to products which have been withdrawn from the Australian market for commercial or other reasons;·access to products provided initially to patients through a clinical trial while a marketing application is being considered; and·access to products available overseas but not marketed in Australia.The classes of patients who may access unapproved therapeutic goods prescribed by an Authorised Prescriber are those suffering from a life-threatening or otherwise serious illness or condition (Section 19(6) and 41HC of the Therapeutic Goods Act 1989 and Regulation 12B(2) of the Regulations and Regulation 7.6 of the Medical Devices Regulations).Informed consentIt is a condition of the approval to supply an unapproved therapeutic good for use in Australia that the patient or the patient's legal guardian must be in a position to make an informed decision regarding treatment. Informed consent should be in writing unless there are good reasons to the contrary. Informed consent should be freely given and includes an adequate knowledge of the condition and its consequences, an adequate knowledge of the treatment options, the likelihood of recovery and the long-term prognosis. A patient should be specifically informed of the following:·that the product is not approved (ie registered or listed) in Australia;·possible benefits of treatment and any risks and side effects that are known;·the possibility of unknown risks and late side effects; and·any alternative treatments using approved products which are available. Responsibilities of the PrescriberUnapproved therapeutic goods have undergone little or no evaluation of quality, safety or efficacy by the Therapeutic Goods Administration. Therefore,the responsibility for prescribing an unapproved product rests with the prescriber.The prescriber is best able to determine the needs of the patient and to monitor the outcome of therapy. The prescriber has an added responsibility to ensure the patient has given appropriate informed consent prior to treatment. However, an important corollary to the issue of informed consent is that a medical practitioner has the right not to approve the use of an unapproved product if he/she believes there is either insufficient clinical justification or insufficient efficacy and safety data to support the use of the product.Responsibilities of the TGAIn considering requests to supply unapproved (non evaluated) therapeutic goods, the TGA has a responsibility to maintain a flexible and efficient means of ensuring individuals are able to gain timely access to important new therapeutic developments without jeopardising the broader community interest in ensuring that products available in Australia are evaluated for quality, safety and efficacy.In relation to applications from medical practitioners to become Authorised Prescribers, the TGA has a responsibility to determine each application on a case by case basis, taking into account the class of patients for whom treatment is intended, the properties of the product and the expertise of the medical practitioner.In keeping with its overall charter, the TGA also has a responsibility to encourage at all times the availability of approved (evaluated) products. Thus, the various mechanisms for supply of unapproved products are intended to be temporary measures pending general marketing approval of the product. TGA requires that applications to use unapproved products justify adequately why available approved products are not suitable for use. Unfettered access to unapproved products amounts to de-facto marketing and would remove any incentive for a sponsor to seek registration of the unapproved product or for other sponsors to seek registration of alternative, similar products.Rights and Responsibilities of the Sponsoring Company (Supplier)A company is under no obligation to supply an unapproved product merely because it has been prescribed by an Authorised Prescriber. Applicants should check with companies that they will agree to supply before making an application and what costs may be involved. The Commonwealth does not subsidise (through the Pharmaceutical Benefits Scheme) the cost of unapproved products.The sponsor must provide the TGA with six monthly reports detailing the supply of unapproved therapeutic goods to Authorised Prescribers.If a sponsor anticipates long term supply of their product, they should consider whether to submit a marketing application.In relation to the supply of products under the Authorised Prescriber mechanism, sponsors have a responsibility to monitor the use of their products continually and record the safety of the medicine and the balance of its benefit and risk. Ideally, the use of an unapproved medicine or medical device should be the subject of treatment protocols issued by the sponsor, with clear requirements for the treating doctor to report any adverse outcomes to the sponsor.Sponsors of unapproved products are also required to communicate rapidly to the TGA information that has an important bearing on the benefit-risk assessment of the product, particularly any information that may lead changes to the usage of the product by Authorised Prescribers.Conditions of AuthorisationWhen Authorisation is given by the TGA, the Authorised Prescriber will receive a letter of authorisation. This letter includes an attachment which outlines the general conditions upon which any authorisation is granted and, if applicable, a list of conditions specific to that particular authorisation, such as conditions relating to the treatment or monitoring of the specified group of patients, or the use of the specified product. Failure to fulfil these conditions may lead to revocation of the authorisation. A list of general conditions can be found at Appendix 1.The Authorisation is restricted in that:·it applies only to the specified product;·the product can only be prescribed for patients in the Authorised Prescriber's immediate care;·the medical practitioner must continue to have an appropriate ethics committee endorsement in order to supply the unapproved product; and·the Authorisation can be revoked at any time following notice from the TGA.OtherFinal responsibility for the use of an unapproved product within an institution always rests with that institution. Medical practitioners working in an institution may also need approval from the institution's Ethics Committee or Drug and Therapeutics Committee prior to using a particular medicine or device. Applicants should discuss the use of the product with the Chief Pharmacist or person fulfilling this role before applying for authorisation.THE TGA’S ATTITUDE TOWARD EXISTING AUTHORISATIONS WHEN ANOTHER PRODUCT IS APPROVED FOR TREATMENT OF THE SPECIFIC CONDITIONWhen a product containing the same active ingredient as the unapproved product is evaluated and approved for treatment of the specified indication, the TGA will revoke existing 19(5)/41HC authorisations for the unapproved product. This may also apply, in some cases, to unapproved products with an active ingredient in the same therapeutic class as a approved product. Thus, the following condition of approval, specific to an unapproved medicine, is placed on all Authorisations and is included in the set of conditions that accompany all letters of Authorisation:The TGA may give notice of revocation of this Authorisation at any time. Thisapproval is valid until revoked or until [a product with the same activeingredient or in the same therapeutic class] is approved in Australia,whichever is the earlier.Similarly, if a medical device that performs the same function as the unapproved medical device is approved for inclusion in the ARTG, the Authorisation for the unapproved medical device will be revoked.If the Authorised Prescriber wishes to continue to use the unapproved product, he/she will be required to:·produce sufficient clinical justification as to why the approved product is not suitable for use in the patient group; and·submit endorsement from an ethics committee for continued use of the unapproved product. The ethics committee’s letter of endorsement should demonstrate that the ethics committee has considered the request for endorsement in the light of an evaluated and approved treatment having become available.This course of action is imposed in part because it is the TGA's responsibility to encourage at all times the availability of approved (evaluated) products. To do otherwise would remove the incentive for a sponsor to seek registration of the unapproved product or for other sponsors to seek registration of alternative products for treatment of the indication. If a medical practitioner has an interest in the continued, long-term supply of a particular product, he/she should ensure that a sponsor is seeking registration of that product in Australia.HOW TO BECOME AN AUTHORISED PRESCRIBERWho Can Become an Authorised Prescriber?Regulation 12B of the Regulations and Regulation 7.6 of the Medical Devices Regulations stipulate that in order to be eligible for an Authorisation, a medical practitioner must be:· a medical practitioner engaged in clinical practice in a hospital and who has been endorsed by the ethics committee of the hospital; or· a medical practitioner treating patients outside a hospital setting and who has obtained endorsement from an appropriate ethics committee.The legislation contains provisions for those doctors who do not have access to an ethics committee to obtain endorsement from an appropriate specialist college having expertise relevant to the treatment of the condition for which use of the product is being sought.Requesting an Authorisation from TGA - the Overall ApproachApplications should be made in writing and addressed to:For medicines:For medical devices:The Medical Advisor Chief Clinical AdvisorExperimental Drugs Section Office of Devices, Blood and Tissues Drug Safety and Evaluation Branch Therapeutic Goods Administration Therapeutic Goods Administration PO Box 100PO Box 100WODEN ACT 2606WODEN ACT 2606Phone (02) 6232 8679Phone (02) 6232 8104Applications need to address criteria relating to the class of recipients, the product and the prescriber. Applicants can also provide any other information they consider important. In considering whether to grant approval, the TGA delegate will generally consider the quality and extent of the information provided and balance the position in relation to each of the criteria. The applicant should address each criterion set out below and supply the information requested. In reaching a decision, the delegate will have regard to each of the criteria and approval will not be given unless the criteria have been met.The Criteria Used by Delegates in Deciding Whether to give AuthorisationThe major criteria for determining whether approval should be given relate to the class of the patient (recipients), the product and the prescriber.。
