Therapeutic Goods (Clinical Trial Inspections) Specification (No. 2) 2020

The instrument rests on a small number of interlocking concepts, each defined or invoked in s 4 and Schedule 1. Set out plainly, those concepts are:

• Therapeutic goods information: the statutory term in s 61(1) of the Act. The instrument does not restate s 61(1); it uses the term in the context of releases under subsection 61(5AA) of the Act (s 5).

• Relevant authorised officer: defined in s 4 by reference to the authorised officer or authorised person who has exercised powers under regulation 12AC of the Regulations or regulation 7.4 of the MD Regulations. The instrument therefore ties permitted information releases to information that results from execution of inspection or investigatory powers under those regulations.

• Approving authority: a site-level governance entity at whose site the clinical trial (or part of it) is being conducted and which is responsible for governance of the trial at that site, other than matters within the remit of the responsible ethics committee (s 4). The approving authority is a recipient class in Schedule 1, column 3.

• Responsible ethics committee: the ethics committee responsible for approving the procedural protocol and monitoring the conduct of the clinical trial at each trial site (s 4). It is the other recipient class in Schedule 1, column 3.

• Procedural protocol: explicitly defined as the trial protocol describing objectives, design, methodology, statistical considerations and organisation of the clinical trial (s 4). The instrument uses this as a benchmark for compliance information.

• National Statement and Practice Guideline: external normative documents adopted by reference in s 4. Schedule 1 item 1 expressly lists compliance with those documents as kinds of information that may be released.

• Purpose-limited release: the Schedule 1 table (as implemented by s 5) ties the release to a stated purpose in column 4: ensuring clinical trials are conducted safely and lawfully and in accordance with applicable ethics and good clinical practice considerations. The instrument therefore frames disclosure in purpose-specific terms.

Key structural points flow from these concepts. First, the instrument is subordinate legislation made under the Act; it does not itself create inspection powers or define the content of the National Statement or Practice Guideline. Second, the instrument’s scope is bounded: only certain kinds of information (conduct and compliance information obtained by a relevant authorised officer) can be released, and only to two classes of recipients for a delineated purpose (Schedule 1 item 1). Third, the instrument is permissive rather than mandatory; the Secretary’s ability to release is couched as “may release” (s 5), so it is a specification of permitted releases rather than a duty to release. Fourth, the instrument relies on external regimes and documents , the Regulations, the MD Regulations, the National Statement and the Practice Guideline , to define both the source of information and the standards against which compliance is judged (s 4; Schedule 1).

The instrument affects a narrow set of actors by name and a broader set indirectly through the mechanics of inspections and governance.

Named and directly affected persons or bodies (see s 4 and Schedule 1):

• The Secretary of the Department responsible for the Act. The Secretary is the official who may release information under subsection 61(5AA) of the Act; this instrument specifies what may be released and to whom (s 3; s 5; Schedule 1).
• Relevant authorised officers. The instrument defines a “relevant authorised officer” as the authorised officer who has exercised powers under regulation 12AC of the Regulations or the authorised person who has exercised powers under regulation 7.4 of the MD Regulations (s 4). Information that may be released must have been obtained by such an officer (Schedule 1 item 1).
• Approving authorities. Defined at s 4 as the person, body or organisation at a trial site responsible for governance at that site, other than matters within the remit of the responsible ethics committee. They are identified as recipients in Schedule 1, column 3.
• Responsible ethics committees. Defined at s 4 as the committee responsible for approving the procedural protocol and monitoring trial conduct at each trial site. They are also listed as recipients in Schedule 1, column 3.
• Therapeutic Goods Administration. The instrument defines the term as in the Regulations (s 4), which situates the instrument within the broader regulatory framework managed by the TGA.

Indirectly affected actors:

• Clinical trial sponsors and investigators. Although the instrument does not name sponsors or investigators, the information subject to release concerns the conduct of clinical trials and compliance with the procedural protocol, National Statement and Practice Guideline (Schedule 1 item 1). Those whose trials are inspected will therefore be the ultimate subjects of the information obtained by authorised officers.
• Trial participants. The instrument does not expressly mention participants, but release of compliance information about trial conduct could implicate participant safety or consent processes as the Schedule 1 compliance items include the National Statement and the trial protocol.
• Institutions hosting trials. Approving authorities are described in site-level terms (s 4), so hospitals, research institutions and sites that host trials may be recipients if they are the approving authority at the site.
• Entities operating ethics committees. Responsible ethics committees that approve and monitor trials are recipients and therefore directly affected.

Who bears costs and responsibilities:

• The Secretary (or the Administration) decides whether to release information; the instrument gives the Secretary discretion to release specified kinds of information (s 5). The instrument does not prescribe funding or fee recovery mechanisms for handling or releasing information; it is silent on who funds the administrative cost of release.
• Approving authorities and responsible ethics committees will receive information the Secretary may release; the instrument does not create specific statutory duties for those recipients regarding how they must act on the information, but they are the intended recipients for the stated purpose (s 5 and Schedule 1).

The instrument therefore affects both regulators and the institutional actors that govern or oversee clinical trials, while placing the initial gatekeeping role with relevant authorised officers and the Secretary.

The instrument is short and does not create broad new duties or rights; it specifies permitted information flows and defines the relevant terms that govern those flows. The key legal mechanics and associated obligations or entitlements are as follows:

Secretary’s discretion to release information

• Section 5 implements the operation of subsection 61(5AA) of the Act by specifying the kinds of therapeutic goods information that the Secretary may release, the recipients and the purpose (s 5; Schedule 1). The instrument frames the Secretary’s power as permissive (“may release”), not mandatory. The instrument therefore creates an entitlement to release for the Secretary but does not impose a duty to release in any given case.

Recipient entitlements

• Approving authorities and responsible ethics committees are identified in Schedule 1, column 3 as classes of persons or bodies to whom the specified trial conduct information may be released (Schedule 1 item 1). The instrument gives these entities the legal position of authorised recipients under subsection 61(5AA) of the Act as implemented by the instrument.

Limits on the scope of information released

• The kinds of information that may be released are limited to information about the conduct of a relevant trial that has been obtained by a relevant authorised officer, and specifically information relating to compliance with the National Statement, the procedural protocol and the Practice Guideline (Schedule 1 item 1). The instrument does not expand releases to financial, commercial, or other classes of therapeutic goods information beyond conduct and compliance as described.

Definition-driven rights and obligations

• Definitions in s 4 shape who is covered and what is captured. For example, “approving authority” is defined as the site-level governance entity responsible for governance of the trial at the site except for matters within the responsible ethics committee’s remit (s 4). That definition determines which body is a permissible recipient. Similarly, “responsible ethics committee” is defined by reference to approval of the protocol and monitoring at each site (s 4), again shaping entitlement to receive information.

Tether to authorised officer activity

• The instrument restricts permissible disclosures to information “obtained by a relevant authorised officer” (Schedule 1 item 1). The identity of “relevant authorised officer” is defined by reference to exercise of powers under regulation 12AC of the Regulations or regulation 7.4 of the MD Regulations (s 4). In practice, this ties the legal right to receive information to the operational fact that an authorised officer has exercised statutory powers under the Regulations or MD Regulations.

No new investigative powers or obligations for recipients

• The instrument does not itself create new investigatory powers for the recipients, nor does it impose explicit statutory duties on approving authorities or ethics committees to take specific action once they receive information. The stated purpose (Schedule 1 column 4) is to ensure trials are conducted safely and lawfully, but the instrument does not set out procedural obligations for recipients or timelines for action.

Silence on confidentiality, redaction and onward use

• The instrument does not specify protections, redaction rules, or limits on onward disclosure by recipients. It confines the Secretary’s release to the listed recipients and purpose, but it does not prescribe how recipients must treat the information once received.

In sum, the instrument confers a permissive release power on the Secretary (s 5), defines who qualifies as a recipient (s 4; Schedule 1), narrows the kinds of information that can be released to compliance and conduct matters obtained by authorised officers (Schedule 1 item 1), and ties the source of information to authorised officer action under the Regulations or MD Regulations (s 4). It does not create new duties on recipients, nor does it create or alter inspection powers.

The instrument itself does not create criminal or civil penalties, nor does it amend enforcement powers under the principal Act or the Regulations. Its operational effect is to specify permitted information releases; enforcement and penalties for non-compliant conduct remain matters governed by the Act, the Regulations, and other applicable law, not by this instrument.

Mechanisms that bear on enforcement, as derived from the instrument:

• Source of enforceable findings: The information that may be released is information “obtained by a relevant authorised officer” pursuant to exercise of powers under regulation 12AC of the Regulations or regulation 7.4 of the MD Regulations (s 4; Schedule 1 item 1). Those regulations (not reproduced in this instrument) contain the inspection and evidence-gathering powers that produce information that could later underpin enforcement action under the Act. This instrument does not alter those powers; it simply specifies that information obtained in that way may be released to approving authorities and responsible ethics committees.

• Intended use of information: Schedule 1, column 4, links the release to the purpose of ensuring clinical trials are conducted safely and lawfully and in accordance with applicable ethics and good clinical practice considerations. That purpose suggests that releases would be used to prompt compliance action by approving authorities, ethics committees, or regulators. However, the instrument does not itself authorise enforcement steps or prescribe remedies.

• No penalties in instrument: There are no penalty provisions, infringement notices, or civil enforcement measures in the text of this instrument. It does not create new contraventions or sanctioning powers. Any penalties for non-compliant clinical-trial conduct therefore continue to derive from other statutory provisions , principally the Act, the Regulations, or other applicable statutory or common law provisions , none of which are amended or supplemented in text by this instrument.

• Administrative discretion as practical enforcement lever: Because the Secretary “may release” information (s 5), the administrative discretion to release information can be used as a compliance tool: the fact of release to an approving authority or ethics committee signals regulatory findings or concerns. The instrument does not specify whether a release must be accompanied by findings, recommendations, or follow-up requirements.

• Omitted safeguards and procedures: The instrument is silent on procedural protections for those whose information is released (for example, notice, opportunity to comment, confidentiality protocols, or redaction). Because it does not spell out such procedures, recipients and subjects of the information must look to the Act, the Regulations, organisational policies, or administrative practice for applicable safeguards or for any avenues to contest or respond to released information.

In short, the instrument is an information-sharing specification rather than an enforcement instrument. It channels data derived from authorised officer activity to site-level governance and ethics oversight bodies for the stated regulatory purpose, but it does not itself impose penalties or change the statutory enforcement toolkit.

The instrument operates within the existing statutory ecosystem of the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 (Regulations), and the Therapeutic Goods (Medical Devices) Regulations 2002 (MD Regulations). It makes cross-references and imports external documents; those interactions define its limits and effect.

Statutory parentage and interaction

• Made under the Act: The instrument is expressly made under subsection 61(5AB) of the Act (s 3). Section 5 gives effect to subsection 61(5AA) of the Act by specifying, for each item in Schedule 1, the kinds of therapeutic goods information that may be released to persons/bodies specified under subsection 61(5AB) and for the specified purpose. Thus the instrument functions as an implementation specification of the Act’s information-release regime rather than a stand-alone statutory code.

• Dependent on inspection powers in the Regulations and MD Regulations: The definitions and triggering condition for releasable information depend on authorised officers having “exercised powers” under regulation 12AC of the Regulations or regulation 7.4 of the MD Regulations (s 4; Schedule 1 item 1). The instrument does not modify those regulations; rather it depends on the evidence-gathering and inspection activity they authorise. Consequently, to understand the scope of actual information that can be released in practice, one must look to those regulations for the scope of authorised officer powers.

Normative references imported by reference

• National Statement and Practice Guideline: The instrument defines those two documents in s 4 “as in force or existing at the commencement of this instrument”. Schedule 1 item 1 makes compliance with those documents a defined kind of releasable information. The instrument therefore imports these external standards as benchmarks for compliance information without reproducing their substantive content. Any legal or ethical duties in those documents remain external to this instrument; the instrument simply permits release of information that relates to compliance with them.

Relationship to the Therapeutic Goods Administration and internal processes

• The instrument refers to the Therapeutic Goods Administration as defined in the Regulations (s 4). It is silent about internal TGA procedures, record-keeping, or information-management practices. The mechanics of release , redaction, timing, or internal approvals , are not specified and are therefore governed by the Act, the Regulations, or departmental policy rather than the instrument itself.

Silences that affect legal interaction

• No data-protection or confidentiality regime articulated: The instrument does not set rules for privacy, confidentiality, or onward disclosure beyond naming recipients and stating the purpose (Schedule 1). Interaction with privacy law or other confidentiality obligations is therefore dependent on separate legal regimes (for example, privacy legislation or professional confidentiality duties) and departmental policy. The instrument does not state whether it overrides, supplements or is subject to those other regimes.

• No changes to enforcement or sanctioning powers: The instrument does not amend the enforcement provisions of the Act or the Regulations. Any interaction with enforcement law arises through the underlying information obtained under the Regulations or MD Regulations and through recipient action within their legal remit.

Procedural interaction with ethics and governance frameworks

• By directing releases to approving authorities and responsible ethics committees (Schedule 1 column 3), the instrument situates the TGA’s inspection outputs within site-level governance and ethics oversight processes governed by the National Statement and institutional policy. The instrument does not prescribe how those bodies must act on received information; their duties derive from separate ethics frameworks, institutional charters or the National Statement itself.

In sum, the instrument is an internal specification that operates by reference to the Act and subordinate regulations and that imports external standards for the purpose of describing releasable compliance information. It does not displace the substantive content of the referenced instruments; rather it creates a channel for information arising under the Regulations and MD Regulations to flow to site-level governance and ethics bodies for a stated regulatory purpose.

The instrument identifies itself as the Therapeutic Goods (Clinical Trial Inspections) Specification (No. 2) 2020 (s 1). The instrument does not include a schedule of amendments or an attached history of prior instruments. There is no text in the instrument that records prior versions, repeal dates, or amending instruments.

What the instrument records:

• Name and year: The instrument’s name and its designation “(No. 2) 2020” appear in s 1. This identifies it as a 2020 instrument and suggests that it is either the second instrument of that title in 2020 or the second iteration of such a specification, but the instrument itself does not elaborate.

What the instrument does not record:

• No explicit repeals or prior instruments are listed in the text provided. The instrument does not state whether it replaces or supplements any prior instrument, nor does it include commencement details beyond being “as in force or existing at the commencement of this instrument” for the external documents it references (the National Statement and the Practice Guideline) (s 4). It does not present an amendment table or a legislative history section.

Implications for users:

• Practitioners seeking amendment history, superseding instruments, or the legislative timeline will need to consult external sources: government legislative instruments registers, Federal Register of Legislation, or departmental release notes. The instrument itself does not supply that information.

Because the only internal historical marker in the text is the instrument’s title and year (s 1), this is the only confirmed administrative-history detail contained within the instrument.

The instrument’s text contains no references to litigation, court decisions, challenges, or judicial interpretation. It does not cite any cases, and no case law is embedded or summarised in the instrument itself.

What this means in practice:

• There is no litigation record contained within the instrument to indicate how courts have treated its operation or the interaction between the instrument and the Act or Regulations. The instrument does not mention judicial review, appeals, or prior adjudication under the Act or subsection 61(5AA)/(5AB).

Practical implications for counsel and reviewers:

• Because the instrument is subordinate legislation specifying permitted information releases, any litigation likely to arise would concern the exercise of administrative discretions under the Act, the correctness of an authorised officer’s exercise of powers under the Regulations or MD Regulations, or the lawfulness of information releases by the Secretary under the Act. The instrument itself provides no guidance on how those issues have been treated by courts.

• For specific disputes arising from an information release under this instrument, parties and advisers would need to rely on the text of the Act, the Regulations, departmental policy and any relevant judicial decisions on those instruments. The instrument does not identify any precedent or judicial guidance.

In short, the instrument contains no litigation history or references to judicial treatment; any judicial questions about the instrument’s application would have to be traced through external sources and case law concerning the Act and the Regulations.

This instrument is small, but several features and silences can produce practical traps for regulators, approving authorities, responsible ethics committees, trial sponsors and site operators. The following points flag concrete operational and legal “gotchas” grounded in the text.

1. “May release” is permissive not mandatory (s 5)

• The Secretary’s power is discretionary: the instrument specifies that the kinds of information “may be released.” Do not assume any recipient has an enforceable right to obtain information; the instrument grants a permissive authority to the Secretary rather than creating a statutory right to compel release.

2. Release is triggered only by information obtained by a “relevant authorised officer” (s 4; Schedule 1 item 1)

• The instrument limits releasable information to that obtained by an authorised officer who has exercised powers under regulation 12AC of the Regulations or regulation 7.4 of the MD Regulations. If no authorised officer has exercised those powers, the Secretary’s permission to release under this instrument is not engaged. In other words, the instrument’s operation depends on inspection activity under the Regulations or MD Regulations.

3. Narrow definition of “approving authority” (s 4)

• The approving authority is the body responsible for governance at the site, “other than in relation to those matters within the remit of the responsible ethics committee” (s 4). This means recipients at the site are bifurcated: some governance matters sit with the approving authority and some with the ethics committee. Misidentifying the site recipient could result in the wrong body thinking it is entitled to receive information.

4. The instrument focuses on conduct/compliance information, not broader data

• Schedule 1 item 1 limits the kinds of releasable information to information about the conduct of the relevant trial and information relating to compliance with the National Statement, procedural protocol and Practice Guideline. It does not authorise release of commercial or broader regulatory information about therapeutic goods outside trial conduct as defined in the table.

5. No procedural detail on how releases are to be made or handled

• The instrument is silent on timing, format, redaction, confidentiality, notice to affected parties, or appeal routes for subjects of released information. Practitioners should not assume that internal administrative safeguards are specified by this instrument; they are not. Those protections (if any) must be found in the Act, Regulations, departmental policy, confidentiality regimes, or privacy law.

6. No statement on onward disclosure by recipients

• The instrument names recipients and a purpose but does not specify whether those recipients are permitted or forbidden from sharing the information further. The instrument therefore leaves open the question of how recipients may lawfully use or further disclose the information, which can create uncertainty about secondary dissemination and privacy risks.

7. Reliance on external standards that are imported “as in force at commencement” (s 4)

• The National Statement and Practice Guideline are defined “as in force or existing at the commencement of this instrument.” This phrasing suggests the instrument benchmarks to the versions existing at commencement; however, it does not expressly provide for future amendments or how changes to those documents should be treated for the purpose of information relating to compliance. The phrasing may create questions about which version is applicable for older inspections or for future inspections after those standards are updated.

8. The instrument does not expand enforcement powers

• Although the purpose is to ensure trials are conducted safely and lawfully (Schedule 1 column 4), the instrument does not grant new enforcement powers to the Secretary, authorised officers, approving authorities, or ethics committees. Users should not treat this instrument as authorising sanctioning action.

9. Lack of amendment and commencement detail in the instrument (s 1; s 4 definitions)

• The instrument’s title indicates it is (No. 2) 2020, but the instrument itself does not include commencement specifics, a revision history, or explanatory material. Users requiring authoritative commencement dates and related instruments must consult external legislative registers.

10. Interaction with privacy and confidentiality obligations is unclear

• Because the instrument does not address privacy, confidentiality, or data security for released information, recipients must consider applicable privacy law, institutional confidentiality policies and professional obligations when handling released material. The instrument provides no guidance or safe-harbour on that point.

These points are concrete consequences of text and silence in the instrument. Practitioners should not infer procedural protections, mandatory disclosure obligations, or changes to enforcement powers from this instrument alone.

The instrument imposes no affirmative statutory duties on approving authorities or responsible ethics committees to receive, act on, or retain information; it permits a release from the Secretary to those bodies. Nevertheless, entities likely to be recipients or subjects of released information should take practical steps to be ready and to manage risks consistent with the instrument’s scope.

Practical steps for approving authorities and trial sites

• Establish a receipt-and-response protocol. Because the instrument allows the Secretary to release information about trial conduct to the approving authority (s 4; Schedule 1 item 1), an approving authority should adopt an internal process for receiving such releases. That process should identify responsible officers, timelines for internal review, steps for immediate participant-safety actions, and escalation paths to institutional governance or legal teams.

• Map remit boundaries between approving authority and the responsible ethics committee. The definition of approving authority excludes matters within the remit of the responsible ethics committee (s 4). Institutions should document which governance matters will be handled by the approving authority versus the ethics committee, so that when information is released the correct body handles it without jurisdictional delay.

• Keep the procedural protocol and records readily available. Schedule 1 item 1 specifically references compliance with the procedural protocol as a category of releasable information. Approving authorities should ensure that up-to-date protocols, amendments, deviations and monitoring records are accessible to meet queries arising from an authorised officer’s findings.

Practical steps for responsible ethics committees

• Prepare to receive and evaluate conduct/compliance information. The ethics committee is a listed recipient for information obtained by relevant authorised officers (s 4; Schedule 1). The committee should define processes for triaging such information, assessing participant-safety implications under the National Statement, and documenting any remedial actions or reporting to institutional governance.

• Document decisions in line with the National Statement. The instrument ties releasable information to compliance with the National Statement (s 4; Schedule 1 item 1). Ethics committees should ensure their decisions and monitoring records reflect the National Statement’s requirements, so that they can demonstrate oversight in response to information releases.

Practical steps for clinical-trial sponsors and investigators

• Maintain inspection-ready documentation. Because the instrument limits releases to information obtained by authorised officers exercising powers under regulation 12AC of the Regulations or regulation 7.4 of the MD Regulations (s 4), sponsors and investigators should ensure documentation evidencing compliance with the procedural protocol, the National Statement and the Practice Guideline is complete, dated, and retrievable.

• Anticipate potential information flows. Sponsors should be ready for authorised-officer inspection findings to be shared with site-level governance and ethics bodies. Establish internal policies for rapid response to information released to the approving authority or ethics committee to avoid delays in remediation.

Practical steps for authorised officers and the Secretary

• Maintain clear records of what information is obtained under which regulatory power. Schedule 1 restricts releasable information to information obtained by a relevant authorised officer as legally defined (s 4). Authorised officers should record the legal basis for information collection (for example, specific regulation invoked), the nature of the information gathered, and any chain-of-custody considerations to support defensible administrative release decisions.

• Coordinate with departmental privacy officers. Because the instrument does not specify redaction or privacy safeguards, the Secretary should coordinate any release with departmental privacy and legal teams to ensure compliance with privacy law and departmental policy, and to articulate protocols for what is released and how.

Cross-cutting steps for all recipients

• Establish confidentiality handling and secondary-use policies. The instrument does not state whether recipients may disseminate released information beyond the approving authority or responsible ethics committee, nor does it set retention or destruction rules. Recipients should adopt policies addressing confidentiality, secondary disclosure, retention, and secure storage consistent with applicable privacy law and institutional obligations.

• Seek legal advice for contested releases. Because the instrument authorises release by discretion, recipients who are presented with released information should consider early legal advice on obligations to act, reporting duties, and potential liability, particularly where information alleges non-compliance with ethics or safety standards.

• Train relevant personnel on the scope of the instrument. Training should cover the fact that the instrument is limited to conduct/compliance information obtained by relevant authorised officers and that it does not itself confer enforcement powers or change obligations under the National Statement or the procedural protocol.

What the instrument does not require

• The instrument does not require recipients to take particular legal or remedial action after receiving information. It also does not mandate how the Secretary must manage or redact information prior to release. Compliance steps therefore focus on risk management, record-keeping and internal governance rather than compliance with new statutory obligations created by this instrument.

By preparing internal procedures for receipt and response, clarifying institutional roles between approving authority and ethics committee, and ensuring documentation supporting compliance with the procedural protocol, the National Statement and the Practice Guideline is current and accessible, institutions and sponsors can align operationally with the instrument’s information-sharing pathway.