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New Zealand looks to revise its abbreviated process policy

04-Mar-2014
Last updated on 04-Mar-2014 at 15:06 GMT2014-03-04T15:06:46Z

New Zealand looks to revise its abbreviated process policy

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.

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