New Zealand looks to revise its abbreviated process policy

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.