Published: 29 January 2014

Consultations

Proposed revision of abbreviated process policy

To:
Product sponsors
Regulatory affairs consultants

Background

The basis for the abbreviated evaluation procedure is the review of overseas regulatory evaluation reports rather than a full review of the medicine dossier. The abbreviated evaluation process is intended to be a simpler and quicker process than the standard evaluation process.

Current eligibility criteria

Currently, to be eligible for the abbreviated evaluation process, a new medicine must:

• have received its approval from a recognised regulatory authority since 1 January 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
•  be identical to the product approved by the recognised regulatory authority in all aspects other than for specific labelling and packaging requirements. If changes have been made to product details since approval these must be supported by overseas evaluation reports and evidence of approval. The regulatory authority that has approved the changes must be the same authority that granted the original approval.

Proposed change

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”.

There are no proposed changes to the other criteria listed above.

Medsafe proposes medicines that have received approval from a recognised regulatory authority since 1 January 2001 but not within the last five years may still be eligible, subject to Medsafe’s discretion. Sponsors should contact Medsafe prior to submitting their abbreviated application in this case.

Benefits

The proposed change would avoid abbreviated assessments becoming complicated and lengthy due to applications that were approved by overseas regulators an extended period of time ago, where a number of changes may have been made to the product.

Next steps

The target implementation date for the changes described above is 28 February 2014.

Medsafe welcomes feedback on the proposed revision of the abbreviated process policy. Queries about, or comments on, the proposed changes described above should be sent to:

Sarah Reader
Medsafe
PO Box 5013
WELLINGTON

Email: askmedsafe@health.govt.nz

by 28 February 2014

Comment on the feedback received and any resulting adjustments to the new requirements will be provided through the Medsafe website (www.medsafe.govt.nz).

Yours sincerely

Sarah Reader
Manager Product Regulation