{"id":"F2023L01291","name":"Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Instrument 2023","slug":"therapeutic-goods-information-specification-database-of-adverse-event-notifications-instrument-2023","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":104825,"registerId":"commonwealth-F2023L01291-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n This instrument is the Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Instrument 2023.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n This instrument is made under section 61(5D) 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) biological;\n (b) manufacturer;\n (c) medical device;\n (d) medicine;\n (e) Register;\n (f) Secretary;\n (g) sponsor;\n (h) therapeutic goods.\n In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> adverse event means the following:\n\n (a) in relation to a medicine or biological—an adverse event that occurs in relation to a person in Australia following the administration of a medicine or a biological;\n (b) in relation to a medical device or other therapeutic good—an adverse event that occurs in relation to a person in Australia following use of a medical device or other therapeutic good that led, or might have led, to the death of, a serious injury to, or serious deterioration in the health of, that person.\n\n> Note: An adverse event may not necessarily have a causal relationship with the administration or use of the therapeutic good.\n\n> DAEN – Medical Devices means the Database of Adverse Event Notifications for medical devices and other therapeutic goods, maintained by the Therapeutic Goods Administration.\n\n> DAEN – Medicines means the Database of Adverse Event Notifications for medicines and biologicals, maintained by the Therapeutic Goods Administration.\n\n> defect, in relation to a medical device or other therapeutic good, means any of the following that might lead, or might have led, to the death of, a serious injury to, or serious deterioration in the health of, a person:\n\n (a) any malfunction or deterioration in the characteristics or performance of the medical device or other therapeutic good;\n (b) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the medical device or other therapeutic good.\n\n> event outcome, in relation to a medical device or other therapeutic good, means one of the following outcomes reported to the TGA in relation to an adverse event:\n\n (a) death;\n (b) injury;\n (c) no injury;\n (d) unknown.\n\n> event type, in relation to a medical device or other therapeutic good, means the event type described in the IMDRF Terminology Document that is applicable to the adverse event.\n\n> IMDRF Terminology Document means the Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes, published by the International Medical Device Regulators Forum, as in force or existing from time to time.\n\n> MedDRA means the Medical Dictionary for Regulatory Activities published by the MedDRA Maintenance and Support Services Organization, as in force or existing from time to time.\n\n> other therapeutic good means a therapeutic good that is not a medicine, biological or medical device.\n\n> report source category, in relation to a medical device or other therapeutic good, means one of the following categories describing the person who reported the adverse event:\n\n (a) consumer;\n (b) health professional;\n (c) industry;\n (d) government;\n (e) other.\n\n> Therapeutic Goods Administration, or TGA, means the part of the Department known as the Therapeutic Goods Administration.\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 The kinds of therapeutic goods information set out in the tables in Parts 1 and 2 of Schedule 1 are specified for the purpose of subsection 61(5C) of the Act.\n\n> Note: Kinds of therapeutic goods information specified under subsection 61(5D) of the Act may be released by the Secretary to the public under subsection 61(5C).\n\n \n\nSchedule 1—Therapeutic goods information\n\nNote: See section 5.","sortOrder":3},{"sectionNumber":"Part 1","sectionType":"part","heading":"DAEN — Medical Devices","content":"## Part 1—DAEN – Medical Devices\n\n| Column 1 | Column 2 |\n| -------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| Item | Kinds of therapeutic goods information |\n| 1 | information about an adverse event or defect in relation to a medical device or other therapeutic good, that has been reported to the TGA and is recorded in the DAEN – Medical Devices (medical device adverse event report), as follows:(a) details of the medical device or other therapeutic good;(b) details of the manufacturer of the medical device or other therapeutic good;(c) details of the sponsor of the medical device or other therapeutic good;(d) details of any other therapeutic good reported to have been involved in the adverse event;(e) the description of the adverse event;(f) the event outcome;(g) the event type;(h) the report source category;(i) the date that the medical device adverse event report was received by the TGA;(j) the unique number allocated to the medical device adverse event report by the TGA |","sortOrder":4},{"sectionNumber":"Part 2","sectionType":"part","heading":"DAEN — Medicines","content":"## Part 2—DAEN – Medicines\n\n| Column 1 | Column 2 |\n| -------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| Item | Kinds of therapeutic goods information |\n| 1 | information about an adverse event in relation to a medicine or biological that has been reported to the TGA and is recorded in the DAEN – Medicines (medicine adverse event report), as follows:(a) details of the medicine or biological;(b) details of any other therapeutic good administered to the person who is reported to have suffered the adverse event (the relevant person);(c) the age of the relevant person;(d) the sex of the relevant person;(e) the adverse event description term, as described in the MedDRA, that relates to the adverse event;(f) the date that the adverse event was recorded by the TGA;(g) the unique number allocated to the adverse event report by the TGA |\n| 2 | information collated by the TGA from reports of adverse events received by the TGA in relation to a medicine or biological and recorded in the DAEN – Medicines (relevant cases), as follows:(a) the number of relevant cases;(b) the number of relevant cases where death was a reported outcome;(c) the number of relevant cases in which the medicine or biological was reported to be the only therapeutic good suspected of being related to the adverse event;(d) the system organ class terminology, as described in the MedDRA, for the part of the body that was reported as being affected by each adverse event;(e) the adverse event description term, as described in the MedDRA, that relates to each adverse event |","sortOrder":5}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"This instrument does not amend the Act; it specifies which kinds of therapeutic‑goods adverse‑event information may be released under existing subsection 61(5C). It narrows the operational scope by listing discrete fields and aggregated counts for DAEN – Medical Devices and DAEN – Medicines (see section 5 and Schedule 1) and by tying some items to external code sets (MedDRA, IMDRF), but it does not expand the statutory power to release information."},"complexity_factors":["Legal authority and administrative discretion: made under section 61(5D) and relates to public release under subsection 61(5C), so publication decisions rest with the Secretary (instrument §3, §5).","Two separate DAEN streams with differing field sets: one for medical devices/other therapeutic goods and one for medicines/biologicals (Schedule 1 Parts 1 and 2).","Dependence on external, evolving terminologies: references to MedDRA and the IMDRF Terminology Document introduce ongoing update and mapping obligations (Definitions).","Technical data elements and nuance: includes outcome, event type, defect definitions and that an adverse event need not be causal—requiring adjudication or labelling choices (Definitions).","Privacy and de‑identification considerations: release includes age, sex, event descriptions and unique report identifiers, creating implementation risk and compliance costs.","Operational mapping and data quality: TGA systems must extract and collate discrete fields and aggregated counts from reports to match the specified items (Schedule 1)."],"plain_english_summary":"This instrument lists the specific adverse‑event data from the Therapeutic Goods Administration’s DAEN databases that the Secretary may publish under the Therapeutic Goods Act.\n\nIt affects sponsors, manufacturers, health professionals and consumers by defining which product, reporter, outcome, demographic and coded‑term fields (including MedDRA and IMDRF codes) and selected aggregated counts will be publishable; the TGA (the Secretary) decides releases and affected parties bear the operational and compliance costs."},"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"This instrument maintains a narrow, specific scope consistent with its original purpose under section 61(5D) of the Therapeutic Goods Act 1989. It simply specifies what therapeutic goods information may be released to the public regarding adverse event notifications. There is no evidence of scope creep; the instrument does not expand beyond information specification for the two existing DAEN databases."},"complexity_factors":["Short, focused instrument (approximately 2 pages) with single operational purpose","13 defined terms in section 4, but most are straightforward technical definitions (e.g., 'MedDRA', 'event outcome')","Simple tabular structure in Schedule 1 with two distinct parts covering separate databases","No nested exceptions or conditional logic—information is either specified for release or not","Minimal cross-referencing: only references to the parent Act (Therapeutic Goods Act 1989) for authority and definitions","Clear separation between medical devices and medicines/biologicals with distinct data fields for each"],"plain_english_summary":"This law defines what safety information Australia’s medicines regulator (the TGA) may publish in its public adverse‑event databases for medical devices and medicines. It governs what users—patients, clinicians, manufacturers and the TGA—can see when checking reports of harm or near‑misses.\n\nThat balance increases transparency about product safety while limiting identifying details to protect patient privacy."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-information-specification-database-of-adverse-event-notifications-instrument-2023","history":"/api/acts/therapeutic-goods-information-specification-database-of-adverse-event-notifications-instrument-2023/history","analysis":"/api/acts/therapeutic-goods-information-specification-database-of-adverse-event-notifications-instrument-2023/analysis","conflicts":"/api/acts/therapeutic-goods-information-specification-database-of-adverse-event-notifications-instrument-2023/conflicts","importantCases":"/api/acts/therapeutic-goods-information-specification-database-of-adverse-event-notifications-instrument-2023/important-cases","documents":"/api/acts/therapeutic-goods-information-specification-database-of-adverse-event-notifications-instrument-2023/documents"}}