{"id":"F2020L01017","name":"Therapeutic Goods (Clinical Trial Inspections) Specification (No. 2) 2020","slug":"therapeutic-goods-clinical-trial-inspections-specification-no-2-2020","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":100405,"registerId":"commonwealth-F2020L01017-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n This instrument is the Therapeutic Goods (Clinical Trial Inspections) Specification (No. 2) 2020.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n This instrument is made under subsection 61(5AB) of the Therapeutic Goods Act 1989.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n (a) medical device;\n (b) Secretary; and\n (c) therapeutic goods.\n In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> approving authority, in relation to a clinical trial of therapeutic goods, means a person, body or organisation:\n\n (a) at whose site the clinical trial, or part of the clinical trial, is being conducted; and\n (b) who is responsible for the governance of the clinical trial, other than in relation to those matters within the remit of the responsible ethics committee, at that site.\n\n> authorised officer has the same meaning as in the Regulations.\n\n> MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> National Statement means the National Statement on Ethical Conduct in Human Research published by the National Health and Medical Research Council, as in force or existing at the commencement of this instrument.\n\n> Note: The National Statement is published on the internet at www.nhmrc.gov.au.\n\n> Practice Guideline means the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), as in force or existing at the commencement of this instrument.\n\n> Note: The Practice Guideline is published on the internet at www.ich.org and may be accessed through www.tga.gov.au.\n\n> procedural protocol, otherwise known as trial protocol, in relation to a clinical trial of therapeutic goods, means the protocol that describes the objectives, design, methodology, statistical considerations and organisation of the clinical trial.\n\n> Regulations means the Therapeutic Goods Regulations 1990.\n\n> relevant authorised officer, in relation to a clinical trial of therapeutic goods, means:\n\n (a) the authorised officer who has exercised powers in accordance with regulation 12AC of the Regulations in relation to the clinical trial; or\n (b) the authorised person who has exercised powers in accordance with regulation 7.4 of the MD Regulations in relation to the clinical trial.\n\n> responsible ethics committee, in relation to a clinical trial of therapeutic goods, means the ethics committee that is responsible for approving the procedural protocol and monitoring the conduct of the clinical trial at each trial site.\n\n> Therapeutic Goods Administration has the same meaning as in the Regulations.\n\n> therapeutic goods information has the meaning given by subsection 61(1) of the Act.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Release of therapeutic goods information","content":"#### 5 Release of therapeutic goods information\n\n For subsection 61(5AA) of the Act, in relation to each item, the kinds of therapeutic goods information specified in column 2 of the table in Schedule 1, may be released to the kinds of persons or bodies specified in column 3, for the purpose specified in column 4 of that table.\n\n> Note: Under subsection 61(5AA) of the Act, the Secretary may release to a person or body that is specified under subsection 61(5AB), specified kinds of therapeutic goods information for a specified purpose.\n\nSchedule 1—Therapeutic goods information\n\nNote: See section 5.\n\n```html\n

Therapeutic goods information that may be released

Column 1

Column 2

Column 3

Column 4

Item

Kinds of information

Kinds of persons or bodies

Purpose

1

in relation to a clinical trial of therapeutic goods (the relevant trial), information about the conduct of the relevant trial that has been obtained by a relevant authorised officer, including information that relates to compliance of the relevant trial with:

(a) the National Statement;

(b) the procedural protocol;

(c) the Practice Guideline

the following persons or bodies in relation to the relevant trial:

(a) the approving authority;

(b) the responsible ethics committee

to ensure that clinical trials are conducted in a safe and lawful manner, including in accordance with applicable ethics and good clinical practice considerations

\n```","sortOrder":3}],"analysis":{"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"This instrument specifies when and to whom therapeutic goods inspection information may be released under the existing subsection 61(5AA)/(5AB) framework (authority stated in section 3). It does not itself amend the Act; it confines releases to inspection information obtained by a relevant authorised officer and to the approving authority and responsible ethics committee for the purpose of ensuring safe and lawful conduct (see section 5 and Schedule 1, Item 1)."},"complexity_factors":["Cross‑references to primary legislation and regulations (made under s.61(5AB) of the Act; see section 3 of this instrument).","Multiple defined terms that import external regimes (definitions in section 4 reference the Act, Regulations, MD Regulations, National Statement and Practice Guideline).","Single table (Schedule 1) that maps kinds of information to specific recipients and a stated purpose — legal effect depends on precise table wording (see section 5 and Schedule 1, Item 1, Columns 2–4).","Release conditioned on information having been obtained by a 'relevant authorised officer' — requires tracing which enforcement power was used (see definition of relevant authorised officer in section 4).","Operational reliance on external, non‑statutory documents (National Statement and ICH addendum) to define compliance benchmarks (section 4 and Schedule 1).","Narrow substantive scope but potentially significant privacy, confidentiality and procedural consequences for trial sponsors, sites and ethics committees because inspection findings are disclosed (Schedule 1)."],"plain_english_summary":"This instrument lets the Secretary release information collected by authorised officers during inspections of clinical trials to the trial’s approving authority and its responsible ethics committee. The released information is limited to matters about how the trial was conducted and whether it complied with the National Statement, the trial protocol and the ICH Good Clinical Practice addendum. It matters because it creates a clear legal route for inspection findings to be shared with site governance and ethics bodies so they can ensure trials are run safely and lawfully."},"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"This instrument performs a narrow, technical function authorised by subsection 61(5AB) of the Therapeutic Goods Act 1989. It specifies what trial inspection information can be released, to whom, and for what purpose. The scope aligns precisely with the parent Act's framework for information sharing and does not expand beyond the original legislative intent."},"complexity_factors":["Short instrument (5 sections plus schedule)","11 defined terms, but most are straightforward cross-references to external documents or the parent Act","Single operative provision (section 5) with a simple tabular structure","Heavy reliance on incorporated external documents (National Statement, ICH E6(R2) guideline) rather than detailed internal rules","No nested exceptions or conditional logic — the release authority is broad and unconditional","Clear one-to-one mapping: specific information → specific recipients → specific purpose"],"plain_english_summary":"This law lets Australia’s drug regulator (the TGA) share inspection findings from clinical trials with the site approving authority and the responsible ethics committee. It covers details about trial conduct and whether the trial follows ethical and good‑practice standards, enabling quicker fixes to compliance or safety problems. It affects sponsors, hospitals and research sites, ethics committees, and TGA inspectors by improving oversight and participant protection."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-clinical-trial-inspections-specification-no-2-2020","history":"/api/acts/therapeutic-goods-clinical-trial-inspections-specification-no-2-2020/history","analysis":"/api/acts/therapeutic-goods-clinical-trial-inspections-specification-no-2-2020/analysis","conflicts":"/api/acts/therapeutic-goods-clinical-trial-inspections-specification-no-2-2020/conflicts","importantCases":"/api/acts/therapeutic-goods-clinical-trial-inspections-specification-no-2-2020/important-cases","documents":"/api/acts/therapeutic-goods-clinical-trial-inspections-specification-no-2-2020/documents"}}