Comparable overseas regulators (CORs) for prescription medicines

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).

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.

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.

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).

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.

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).

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.

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.

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 other 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).