Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Determination 2021

The Determination introduces several defined categories of medicines that determine which products fall within the mandatory eCTD requirement. A “registered medicine” means a medicine included in the part of the Register for goods known as registered goods (distinct from listed or other parts). The categories in Schedule 1 are defined in section 4. A “new chemical entity medicine” means a medicine that contains a new chemical entity as mentioned in paragraphs (a), (b) and (d) of the definition of “new chemical entity” in clause 1 of Part 1 of Schedule 9 to the Regulations. That definition cross references the Therapeutic Goods Regulations 1990, which contains the operative definition of new chemical entity. A “new biological entity medicine” covers a medicine that has not previously been included in the Register and contains a biological substance, or one that contains a biological substance meeting certain criteria under the new chemical entity definition. A “new biosimilar medicine” is a medicine not previously included in the Register that is a biosimilar in relation to a registered medicine. A “new combination medicine” is defined by reference to paragraph (e) of the new chemical entity definition, covering fixed dose combinations. An “extension of indications medicine” contains the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination) as another registered medicine but has one or more additional indications. A “major variation medicine” means a medicine taken to be separate and distinct from a registered medicine due to a major variation, but specifically excludes new chemical entity, new biological entity, new biosimilar, new combination, extension of indications, new generic and new trade name medicines. This exclusionary definition is important: it ensures that major variation applications for less transformative changes remain subject to eCTD, while the more innovative categories are separately listed. A “new generic medicine” has the same meaning as “generic product” in the Regulations, essentially a bioequivalent copy. A “new trade name medicine” has the same active ingredient(s), indications and dosage form as a registered medicine but a different name; note it is not listed in Schedule 1, meaning trade name only applications are not required to use eCTD under this Determination (presumably they use other pathways). The Determination also defines “eCTD” by reference to two specific documents as they existed on 1 April 2025. This static cross referencing prevents format creep but also means any future change to the ICH specification or TGA module 1 will require a formal amendment to this Determination. The concept of “exceptional circumstances” in section 6(b) is deliberately vague, creating a subjective gateway for alternative formats. The class of medicines to which the Determination applies is defined not in this instrument but by reference to another notifiable instrument: the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018. That instrument identifies the class of prescription medicines. Section 4 also notes that key terms from the Act - biological, medicine, Register, registered goods - are defined in subsection 3(1) of the Act. The terms “generic product” and “major variation” are given the same meanings as in the Regulations, linking this Determination to the broader regulatory framework.

The primary persons affected are sponsors of prescription medicines seeking registration in Australia. A sponsor is the person or company who applies to include a medicine in the Register under the Act. The Determination covers applications for the seven types of new medicines listed in Schedule 1. For a sponsor planning to lodge an application for a new chemical entity, new biological entity, new biosimilar, new combination, extension of indications, major variation (except those excluded), or new generic medicine, the application dossier must be assembled and submitted in eCTD format. That requirement directly affects regulatory affairs departments, contract research organisations and consultants who prepare and compile the dossier for submission. The cost of converting data from other formats (such as paper, CTD, or non compliant electronic formats) into the mandated eCTD structure falls on the applicant. For small and medium sized enterprises, the software and training costs for eCTD compliance may be a material barrier. The Determination also indirectly affects the TGA itself, which must maintain the technical infrastructure to receive and review eCTD submissions and to manage the exceptional circumstances exemption process. Patients and prescribers are ultimately affected because the format requirement influences the speed and predictability of the registration process. If the eCTD format improves the TGA’s review efficiency, registration times may shorten, potentially accelerating patient access. Conversely, if the mandatory format imposes conversion delays or increases the risk of rejection for format errors, registrations may slow down. The transitional provision in section 7 divides applicants into two populations: those who lodged before 1 October 2025 (covered by the pre amendment version) and those who lodge on or after that date (covered by the amended version with eCTD references frozen at 1 April 2025). This creates a compliance cliff for late applicants. It also affects industry software vendors who must ensure compatibility with the Australian eCTD specifications and keep pace with the version freeze date. The TGA itself is affected by the Determination because it gives the agency an unfettered discretion to agree to an alternative format in exceptional circumstances, creating a potential administrative burden and risk of inconsistent decision making. Overall the Determination imposes a uniform procedural requirement on a defined segment of the pharmaceutical market, with the compliance costs concentrated on applicants and the benefits (if any) of standardisation shared across the regulator and the public.

The central duty imposed by the Determination is on the applicant for registration of a prescription medicine listed in Schedule 1: the application dossier that accompanies the application must be in the eCTD format (section 6(a)). This is a mandatory obligation. The duty arises from subparagraph 23B(2)(d)(ii) of the Act, which allows the TGA to determine the form of information accompanying an application. Failure to comply with the duty means the application is not in the required form, which may lead to the TGA declining to accept it or treating it as incomplete. The applicant has a corresponding right to request an alternative format if “exceptional circumstances exist” (section 6(b)). However, the Determination does not define “exceptional circumstances”, does not prescribe a process for making the request, and does not require the TGA to even consider a request. The applicant has no right to an alternative format; it is entirely within the TGA’s discretion to give or withhold prior written agreement. The applicant also has the right to rely on the transitional provision in section 7: if the application was made before 1 October 2025, the pre amendment version of the Determination applies. That means the applicant may be subject to a different eCTD specification (presumably an earlier version). The Determination itself does not confer any other rights. It does not create a right to have the application processed within a certain time or to receive reasons for refusal to accept an alternative format. It also does not create a duty on the TGA to publish guidance on what constitutes exceptional circumstances. The TGA’s right to impose conditions on an alternative format agreement is implicit but not spelled out. The applicant’s duty to format the dossier in eCTD is mechanical and technical; it does not extend to the substantive content of the dossier, which remains governed by the Act, the Regulations and any other TGA determinations or guidelines. Because the Determination is made under a specific subsection of the Act, it sits within a hierarchy where the Act may impose additional duties (such as the duty to provide information that is true and correct). The Determination narrows the form but does not expand the applicant’s obligations regarding quality, safety or efficacy data. In practical terms the duty to format forces the applicant to invest in eCTD software and to structure the dossier according to the Australian eCTD module 1 and ICH modules 2 5. The applicant cannot simply repurpose a dossier prepared for another jurisdiction if that dossier uses a different eCTD regional implementation, unless the Australian version aligns. This may create a right to request an alternative format in practice, but the legal entitlement is weak.

The Determination itself does not create any civil or criminal penalties. It is a determination made under subsection 23B(10) of the Act, which confers a power to prescribe the form of information. Non compliance with the Determination is not an offence under this instrument. Instead, the consequences flow through the Act’s provisions for applications. Under section 23B of the Act, the Secretary may require an application to be accompanied by information in the form determined. If the information is not in the required form, the application may be regarded as not properly made. The TGA may reject the application or request that it be resubmitted in the correct format. In practice the TGA has processes for rejecting incomplete or non compliant applications, which may delay the regulatory timeline and require the sponsor to incur additional costs to reformat the dossier. There is no automatic penalty or fine for submitting in the wrong format, but the commercial cost of delay can be substantial. The TGA may also refuse to accept an alternative format unless prior written agreement was obtained, and may disregard any submission made in an alternative format without agreement. This enforcement mechanism is administrative rather than punitive. The Determination also interacts with the TGA’s broader compliance and enforcement powers under Part 6 of the Act, which include powers to suspend or cancel registrations for failure to comply with conditions of registration. But those powers are not directly triggered by a formatting error alone; they relate to ongoing obligations. The Determination does not create any infringement notice provisions, civil penalty provisions, or criminal penalties. The concept of “enforcement” here is best understood as the TGA’s administrative practice of requiring re submission or rejecting non conforming dossiers. The transitional provision in section 7 provides a form of grandfathering: applications lodged before 1 October 2025 are assessed under the earlier version of the Determination, so there is no retroactive enforcement of the new eCTD version for those applications. The Determination’s enforcement is therefore entirely within the TGA’s discretion to determine whether an application meets the formal requirements. There is no private right of action to enforce the Determination. A sponsor who suffers loss because the TGA wrongfully refuses to accept an alternative format might seek judicial review under the Administrative Decisions (Judicial Review) Act 1977, but the standard of review would be highly deferential given the subjective test of “exceptional circumstances”. In short, the principal sanction is administrative rejection, not a monetary penalty.

The Determination is made under the Therapeutic Goods Act 1989, specifically subsection 23B(10). That subsection empowers the Minister to determine, by legislative instrument, matters for the purposes of paragraph 23B(2)(d). Paragraph 23B(2)(d) provides that the information accompanying an application for registration must be in a form determined under subsection (10). Thus the Determination is the instrument that gives effect to that requirement. It operates within the broader framework of the Act, which includes provisions for registration, evaluation, and post market regulation. The Determination also interacts with the Therapeutic Goods Regulations 1990 in several ways. Key definitions - “generic product”, “major variation”, “new chemical entity” - are given the same meanings as in the Regulations. The Regulations contain Schedule 9, Part 1, which defines “major variation” and “new chemical entity”. The Determination does not create independent definitions for those terms but relies on the Regulations, meaning any amendment to the regulation definitions automatically updates the Determination’s scope (subject to transitional provisions). The Determination also refers to the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018, which specifies the class of therapeutic goods to which this determination applies (paragraph 4(1)(a) of that instrument). That instrument is a notifiable legislative instrument; its amendment would change the class of medicines subject to this Determination. The eCTD format itself incorporates by reference two external documents: the TGA’s eCTD AU module 1 and regional information v3.2, and the ICH eCTD Specification v3.2.2, both as in force on 1 April 2025. This means changes to those external documents after that date are not automatically incorporated; they require a formal amendment to the Determination. That reduces regulatory creep but creates a risk of obsolescence. The Determination is one of several TGA instruments dealing with the form of applications. Others include the Therapeutic Goods (Medical Devices) Determination for medical devices and various data protection determinations. It does not override the Act’s requirement for applications to be accompanied by prescribed fees under the Therapeutic Goods Regulations or the fee determinations made under the Act. The Act’s provisions on priority review, orphan drug designation, and other special pathways remain unaffected; the Determination only addresses the format of the dossier, not the content requirements for those pathways. The Determination also interacts with international harmonisation efforts. The ICH eCTD specification is an international standard, so the Determination aligns Australia with the common technical document format used in many jurisdictions. However, the Australian specific module 1 and regional information v3.2 is unique to Australia, creating a local compliance burden. Overall the Determination fills a procedural gap in the Act by specifying the form requirement, and it sits within a web of cross references to the Act, the Regulations, another legislative instrument, and external standards.

The instrument is titled the Therapeutic Goods (Prescription Medicines,Information Accompanying Applications for Registration) Determination 2021, indicating it was originally made in 2021. The version provided here includes amendments made by the Therapeutic Goods (Prescription Medicines,Information Accompanying Applications for Registration) Amendment Determination 2025. The most notable change is the update of the eCTD definitions in section 4 to refer to the documents “as in force or existing on 1 April 2025”. Before that amendment, the definitions presumably referred to earlier versions of the TGA module 1 and ICH specification. The Amendment Determination also inserted the transitional provision in section 7, which preserves the older version for applications made before 1 October 2025. This suggests the eCTD technical standards were updated, and the TGA provided a six month transition period for industry to adjust from the old standard to the new one. Applications lodged before 1 October 2025 remain subject to the pre amendment Determination, while applications lodged on or after that date must comply with the version incorporating the 1 April 2025 references. The Amendment Determination itself is not provided, but its effect is clear from the current text. The original 2021 Determination would have been made following consultation and would have replaced any earlier directions on the form of information. The amendment history shows that the TGA recognises the need to update technical standards but also appreciates the compliance burden of doing so, hence the transitional period. There is no indication of any multiple amendments between 2021 and 2025; only one amendment Determination is referenced. The instrument is a legislative instrument registered under the Legislation Act 2003, and its amendment history would be publicly available on the Federal Register of Legislation. The transitional arrangement effectively creates two concurrent regimes: one for historical applications and one for new applications after the transition date. This is a common technique to avoid invalidating applications in progress. The definition of “eCTD” using a fixed date rather than “as amended from time to time” is significant. It means future updates to the ICH specification or TGA module 1 will not automatically apply; they will require a further amending instrument. This provides regulatory certainty for industry but may lead to a divergence between Australian requirements and future international standards, forcing the TGA to choose between updating the instrument or falling behind.

The source text contains no references to any litigation. No cases are cited in the Determination itself, and no judicial decisions are mentioned. This is consistent with the nature of the instrument as a procedural determination specifying a format requirement. However, it is possible that cases have been brought under the Act challenging the TGA’s rejection of an application on procedural grounds, including format non compliance. Such cases would typically be heard in the Federal Court or the Administrative Appeals Tribunal (AAT). The principal avenue for review would be under the Administrative Decisions (Judicial Review) Act 1977, as the TGA’s decision to refuse to accept an application or to refuse an alternative format request would be a decision of an administrative character. Grounds might include that the TGA failed to properly consider whether exceptional circumstances existed, or that the Determination itself is invalid. No such cases are publicly prominent. The Determination’s discretionary element - “if exceptional circumstances exist” - could be challenged for unreasonableness if the TGA applied an inflexible policy. But the Determination gives broad discretion and does not set criteria, making challenge difficult. The transitional provision could also be challenged if an applicant claimed it was arbitrary to draw the line at 1 October 2025. But that would be an unlikely basis for invalidity. Given the instrument has been in force since 2021, it is probable that many applications have been processed under it without generating reported litigation. The absence of litigation may also reflect the commercial reality that sponsors prefer to comply with technical format requirements rather than incur the cost and delay of legal proceedings. The eCTD format is widely used internationally, so most major sponsors already have eCTD submission capability for other jurisdictions. Litigation would be disproportionate to the issue. In summary, there is no known litigation history specific to this Determination, and the source does not mention any. Any reader should still be aware that the underlying Act has been litigated extensively, including the scope of the Secretary’s powers to impose conditions on registration, but those cases do not directly interpret this Determination.

Several traps exist for unwary applicants. First, the definition of “eCTD” refers to documents as they existed on 1 April 2025. If a sponsor relies on a later version of the ICH specification or a later TGA module 1, the dossier would be non compliant, even if the differences are minor. The Determination does not permit use of an updated version unless an amendment is made. Second, the term “exceptional circumstances” is undefined, giving the TGA an unfettered veto over alternative formats. A sponsor who assumes that a minor technical glitch or system incompatibility qualifies as exceptional may be disabused. There is no right of review if the TGA denies the request. Third, the transitional provision in section 7 is a trap for the unwary: applications lodged before 1 October 2025 are governed by the pre amendment Determination. But what constitutes the date of application? The Act and Regulations may treat an application as made when it is lodged and the fee is paid. A sponsor who files on 30 September 2025 but whose payment is processed on 2 October 2025 may inadvertently fall into the new regime. The exact meaning of “made” is not defined in the Determination. Fourth, the exclusion of certain categories from the definition of “major variation medicine” in section 4 means that if a major variation falls into one of the excluded subparagraphs (a) to (g) - e.g. a new chemical entity or a new combination medicine - it is not a “major variation medicine” for the purposes of the Schedule. But those excluded types are themselves listed separately in the Schedule (Items 1, 2, 3, 4, 5, 7). So the exclusion is circular but ensures no double counting. A sponsor might incorrectly assume that a major variation that creates a new chemical entity is covered only by Item 6, when it is actually covered by Item 1. Fifth, the Determination applies only to medicines of the class specified in the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018. If the class instrument is amended to add or remove categories, the scope of the Determination changes automatically (since it does not specify a date for that instrument). A sponsor must monitor that separate instrument. Sixth, the eCTD format requires Module 1 to comply with the TGA’s regional spec v3.2. That specification may contain specific Australian requirements (e.g. for product information, patient information, or data exclusivity claims) that differ from the ICH modules. A sponsor who copies a dossier from another jurisdiction may miss those requirements. Seventh, the Determination does not specify which version of eCTD applies for variations or extensions of indications after initial registration; it only covers the initial registration application. Post approval submissions may be governed by other TGA guidance that is not legally binding. Eighth, the term “registered medicine” is defined narrowly as a medicine included in the part of the Register for registered goods. This excludes medicines in the listed or export only parts. If a medicine is already registered in another part of the Register, it may not satisfy the definition, which could affect the “extension of indications” definition. Ninth, the Determination does not address the form of the application itself (the application form), only the accompanying dossier. Applicants must comply with separate requirements for the application document. Tenth, the requirement for “prior written agreement” for an alternative format means oral agreements are insufficient, and the TGA’s silence cannot be construed as consent. The onus is on the applicant to obtain express approval before submitting.

To comply with the Determination, a sponsor must ensure that any application for registration of a prescription medicine listed in Schedule 1 is accompanied by a dossier in eCTD format as defined. Practically, the sponsor must obtain or develop software capable of producing an eCTD submission that conforms to both the ICH eCTD Specification v3.2.2 for Modules 2 to 5 and the TGA’s eCTD AU Module 1 and Regional Information v3.2, both as published on 1 April 2025. The dossier must be structured into the five modules: Module 1 (administrative information and Australian specific content), Module 2 (summaries), Module 3 (quality), Module 4 (nonclinical), Module 5 (clinical). The sponsor should verify the version numbers of those specifications at the date of submission, noting that any later versions are not acceptable under the Determination. For applications lodged before 1 October 2025, the sponsor should instead rely on the pre amendment version of the Determination and ensure compliance with that earlier specification. The sponsor must keep a record of which version applies. If the sponsor believes that exceptional circumstances prevent submission of the dossier in eCTD format, they must seek prior written agreement from the TGA for an alternative format. That request should be made early and should explain in detail why compliance is not possible. The TGA is not obliged to grant the request, so the sponsor should have a contingency plan to reformat the dossier if the request is refused. The sponsor should also confirm the class of goods under the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018 to ensure that the medicine falls within the scope of the Determination. The definitions in section 4 of the Determination should be used to classify the medicine type (e.g. new chemical entity medicine, new biological entity medicine, etc.). Proper classification is important because only the seven items in Schedule 1 are covered. A new trade name medicine, for example, is not listed and therefore not subject to this Determination (it may have other form requirements). Internal compliance procedures should include a checklist: (1) confirm the application is for a prescription medicine within the class, (2) identify the medicine type from Schedule 1, (3) verify the submission date relative to 1 October 2025 to determine which eCTD version applies, (4) assemble the dossier according to the correct eCTD specifications, (5) if an alternative format is needed, submit a written request to the TGA and await agreement, (6) lodge the application with the correct format, (7) retain evidence of the eCTD version used and any TGA agreements. Ongoing compliance beyond the initial registration is not addressed by this Determination; post approval submissions such as notifications or variations may have their own form requirements under separate instruments or guidelines. Sponsors should also be aware that the TGA may publish guidance on eCTD submission, which although not legally binding, may be influential in practice. The cost of compliance includes software licences, training, and potential consultant fees. Those costs should be factored into the overall budget for regulatory submissions. The Determination does not impose a duty to use a specific submission platform; any eCTD tool that produces a valid dossier is acceptable. However, the TGA’s own submission system may require the dossier to be uploaded in a particular way. Finally, if the sponsor uses a contract research organisation to prepare the dossier, the sponsor remains responsible for compliance with the Determination. Due diligence should be exercised to ensure the third party is using the correct specification and version. Non compliance may result in the application being rejected or delayed, with significant opportunity cost.