The New Zealand Medicines and Medical Services Safety Authority is looking to update its abbreviated evaluation process, which is intended to be a simpler and quicker process than the standard evaluation process.
The proposed change would avoid complicating abbreviated assessments if applications were approved by overseas regulators a while ago, even if a number of changes may have been made to the product.
The basis for the abbreviated evaluation procedure is to review overseas regulatory evaluation reports rather than fully review a medicine dossier.
Currently, to be eligible for the abbreviated evaluation process, a new medicine must:
- have received its approval from a recognised regulatory authority since January 1, 2001;
- be supported by a complete dataset as required by the Medicines Act 1981 and the New Zealand;
- Regulatory Guidelines for Medicines, consisting of Modules 2, 3, 4, and 5 (as applicable). The dataset should reflect the product details being sought for registration
- contain all documentation as set out in section 2.4.4 of the New Zealand Regulatory Guidelines for Medicines; and
- be identical to the product approved by the recognised regulatory authority in all aspects other than for specific labelling and packaging requirements.
Medsafe proposes that the eligibility criteria for a new medicine be changed from having “received its approval from a recognised regulatory authority since 1 January 2001” to having “received its approval from a recognised regulatory authority within the last five years prior to submitting the abbreviated application to Medsafe.”
Medsafe also proposes that medicines winning approval from a recognised regulatory authority since January 2001, but not within the last five years, may still be eligible for a proposal, subject to Medsafe’s discretion.
Sponsors should contact Medsafe prior to submitting their abbreviated applications in this case.