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Recently updated
This page was updated on [date_placeholder]. See page history for details.
Purpose
This guidance provides an overview of our registration process for applications that need to be supported by nonclinical, clinical and/or bioequivalence data (category 1 and category 2).
Applications to vary a product registration (section 9D of the Act) and not supported by nonclinical, clinical and/or bioequivalence data are outside the scope of this document.
Guidance
This guidance is presented as a downloadable file because of its length.
Downloads
Page history
Updates to expert advisory review phase
- Use of the phrase ACM/ACV rather than only ACM
- Provide additional details regarding the Pre-ACM/ACV responses (within 5.6.4.2)
- Update timeframes for provision of ACM/ACV minutes in line with current practice (within 5.6.3 & 5.6.4.4)
- Removal of the Pharmaceutical subcommittee information
- Expectation for reviewing evaluation reports combined for both applications that attend ACM/ACV and that do not attend ACM/ACV (within 5.7.4.1)
- Inclusion of information about Decision Summaries (within 5.8.5)
- Minor edits to increase readability.
Minor updates to Submissions.
Updated to reflect Provisional approval pathway.
Update to reflect new legislation.
Addition of link to guidance on orphan drug designations.
Second version to reflect outcomes from the public and stakeholder consultation, the introduction of a separate workflow for generic medicines and the opportunity for applicants to consider all evaluation reports at milestone 3.
Original publication.
Updates to expert advisory review phase
- Use of the phrase ACM/ACV rather than only ACM
- Provide additional details regarding the Pre-ACM/ACV responses (within 5.6.4.2)
- Update timeframes for provision of ACM/ACV minutes in line with current practice (within 5.6.3 & 5.6.4.4)
- Removal of the Pharmaceutical subcommittee information
- Expectation for reviewing evaluation reports combined for both applications that attend ACM/ACV and that do not attend ACM/ACV (within 5.7.4.1)
- Inclusion of information about Decision Summaries (within 5.8.5)
- Minor edits to increase readability.
Minor updates to Submissions.
Updated to reflect Provisional approval pathway.
Update to reflect new legislation.
Addition of link to guidance on orphan drug designations.
Second version to reflect outcomes from the public and stakeholder consultation, the introduction of a separate workflow for generic medicines and the opportunity for applicants to consider all evaluation reports at milestone 3.
Original publication.