Using assessments from comparable overseas regulators (CORs) for prescription medicines

These criteria help identify opportunities for enhanced international collaboration in the regulation of prescription medicines.

These criteria apply to the COR report-based processes.

The COR criteria are applied in two stages:

• Stage 1: The first stage sets out the preliminary criteria that confirm that there is sufficient similarity between TGA and the overseas agency to support collaborative work by the TGA's use of an existing, complete assessment report.
• Stage 2: The second stage outlines the parameters that are relevant to a particular submission. These would be considered at the time a submission is made to TGA that proposes reliance on COR assessment reports instead of de novo evaluation. These criteria can also inform first stage considerations.

These criteria have been applied to generate an initial list of overseas agencies for the COR report-based process.

Stage 1 criteria

The first stage sets out the preliminary criteria that confirm that there is sufficient similarity between the overseas agency and us to support collaborative work of this nature.

Criterion 1

The COR's regulatory framework should be similar to that of TGA in terms of what must and must not be taken into account in making regulatory decisions.

To meet this criterion the COR would need to:

• conduct similar pre- and post-market regulatory activities, including
  • Good Manufacturing Practice inspections programs
  • pharmacovigilance programs
  • full de novo assessments (safety, quality and efficacy) of the type of applications that are of interest to us (e.g. assessments of new chemical or biological entities, generic medicines, biosimilars and subsequent variations to these goods)
• have a transparent system for regulating therapeutic goods, including its assessment processes and legal accountability (conflict of interest processes).

Criterion 2

The TGA must have established a formal and robust framework for cooperation with the COR.

To meet this criterion the COR would need to have an agreed Memorandum of Understanding (MOU) or exchange of letters with the TGA that allows clear, open, secure communication on regulatory issues and transmission of confidential information.

Criterion 3

The COR must use international guidelines and standards consistent with those adopted by the TGA.

To meet this criterion the COR would need to have established scientific evaluation processes in accordance with The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and other international guidelines, as well as pharmacopoeial standards adopted by Australia (the European Pharmacopoeia, British Pharmacopoeia and United States Pharmacopeia).

To best make use of overseas assessments, any differences in how these international standards are adopted will need to be well understood.

At the application level, when there are differences identified in the adoption of technical guidelines between the COR and TGA that are relevant to a particular application, this criterion may not be met.

Criterion 4

The COR should be able to conduct their business and release reports in English.

The applicant must have access to the assessment reports and associated supporting documentation (such as (but not limited to) committee/advisory bodies minutes) in English for inclusion in the Australian application (this can include reports that have been translated into English from another language by the COR).

Stage 2 criteria

Stage 2 criteria focus on the specifics of a particular application. Once an overseas regulator has been identified as a source of assessment reports, the following considerations will be applied to determine whether the proposed use of COR reports can proceed.

Criterion 5

Equivalent indication is proposed for the medicine (including dosage regimen and route of administration).

To meet this criterion:

• the proposed indication for the medicine would need to be based on broadly similar population demographics, disease profiles, and expectations regarding public health outcomes between Australia and the COR
• any differences would need to be identified and justified by the applicant
• the medicine application in Australia is identical to the COR application, that is, the Australian medicine application is not a subset or otherwise modified application of the COR application.

Criterion 6

The medicine for which Australian registration is sought is singular and identical to that approved by, or submitted to, the COR (i.e. dosage form, strength, formulation and manufacture).

To meet this criterion, the assessment reports must relate to the same medicine (identical in terms of quality aspects of the product) and each Australian medicine registration application relates to a single medicine and ARTG entry.

The manufacturing process must be identical to that assessed by the COR but additional manufacturing sites can be included in the application to the TGA (under certain conditions).

Criterion 7

Assessment reports should be prepared using guidelines and standards consistent with those used by the TGA.

To meet this criterion, the assessment reports should be prepared in the Common Technical Document (CTD) format and consistent with a methodology used by the TGA. A key consideration is whether the assessment reports have the required scope. For example, in the case of clinical assessments, the TGA would consider what studies and analyses have been included, and for each of these, the data cut-off for analysis.

Differences in methodology may not prevent the use of the assessment reports. However, the TGA would require additional information to address any gaps or concerns, reducing the benefit of using an overseas report. Please also note that if any other assessments of an application by COR have led to differences in indications or patient groups being approved, then this rationale will need to be provided, along with all associated assessment reports and this complexity should be discussed with the TGA prior to submission.

Criterion 8

Assessment reports must be un-redacted and complete.

To meet this criterion, the complete reports should include correspondence related to the application (e.g. questions asked of, and deliberations by, advisory bodies).

The Australian applicant is responsible for providing the reports to us when lodging the application.

Criterion 9

The TGA should be able to use assessment reports and any supplementary information generated during the evaluation process as part of Australian Public Assessment Reports (AusPARs).

To meet this criterion, reports that are provided to the TGA should not be subject to any restrictions on use or disclosure by the TGA oher than those which would apply to any material provided in an application dossier (e.g. these reports must be able to be used as the basis for published AusPARs).

The COR report-based process is open to prescription medicines registration applications, where the medicine has received full overseas marketing approval following a de novo evaluation.

Applications can relate to all types of new prescription medicines, including new chemical entities, new fixed dose combinations, generic medicines, biological medicines and biosimilars.

This process can also be used for variations to existing medicines, including extension of indications or new dosage forms and changes to product information documents that would normally require evaluation of clinical data.

Importantly, the application must not have been delayed, deferred, rejected, refused or withdrawn at any time, in any country.

A COR report of a literature-based submission is unlikely to be suitable for the COR process as the search strategy and evidence may be rapidly superseded. Further consideration will also need to be given to the different methodology used by different jurisdictions for literature-based submissions, and hence further justifications may be required.

Applicants can use the COR criteria to identify suitable assessment reports that have been obtained from a COR. These reports can then be included in a COR report-based application along with the dossier that was submitted to the COR and an Australian Module 1.

• List of countries/jurisdictions for the COR report-based process
• Submission requirements
• Timeframes and milestones
• Requirements for indications

Depending on the quality and scope of the overseas assessment package provided to the TGA, the need to evaluate the data within the dossier may be reduced to a greater or lesser degree.

Pre-submission meeting is encouraged

Due to differences in regulatory frameworks and process requirements, there may be certain applications that are not suited for the COR report-based processes (for example, medicines that include a medical device component).

All applications must meet existing Australian requirements, including those based on COR reports.

We highly recommend that applicants request a pre-submission meeting with TGA to discuss their application before lodging.

Related information

Application forms for this process are available at Prescription medicines application forms.

Contact streamlinedsubmission@health.gov.au for more information.