Published: 21 May 2014
In January 2014, Medsafe published a proposed revision to the eligibility for the abbreviated evaluation process on the Medsafe website, and sought feedback on the proposal by 28 February 2014.
Medsafe proposed that to be eligible for the abbreviated process the application must be for an Intermediate-risk or High-risk medicine that:
Medsafe also proposed that the acceptance of older dossiers would be at its discretion.
Medsafe received five submissions on the proposed changes (two from industry associations and three from sponsors of medicines).
Five submissions were received, and the following issues were raised.
Medsafe’s purpose for revising the eligibility criteria for the abbreviated route is to ensure the efficiency predicted in assessing applications with prior overseas approval is maintained. There has been an increase in submissions of older dossiers approved overseas a large number of years prior, which have been appended with many changes to the product over an extended period of time. In these cases the original regulatory approvals are less relevant to the product proposed for New Zealand which makes an abbreviated assessment complicated and time consuming. An evaluation of the original dossier and overseas assessment reports, as well as multiple post-market changes is required to determine the risks and benefits of the medicine in relation to the New Zealand market.
The resource required to assess these complex and often confusing dossiers needs to be diverted from other applications which results in a general loss of efficiency. It is more appropriate that complex dossiers are assessed via the standard evaluation process.
The original policy intent for the abbreviated route to approval was that only minor changes to the overseas approved product could be included. However, to maximise the benefits of the abbreviated process, some significant post-approval changes need to be accepted to facilitate supply from another market. It was proposed to manage the number of changes incorporated by defining the age of the original approval.
However, in response to the submissions received, Medsafe has decided to continue to accept older dossiers. Rather than specify an acceptable age of the dossier, Medsafe has clarified the eligibility criteria for all applications to be submitted via the abbreviated route. The intent is to ensure a streamlined process by which overseas approved medicines can access the New Zealand market in a shorter time than via the standard evaluation process.
This change will be implemented into the Medsafe business rule on 1 July 2014. Companies with dossiers that cannot be assessed via the abbreviated route may still submit applications through the standard evaluation process. Overseas evaluation reports may still be provided if the applicant wishes these to be taken into consideration.
From 1 July 2014, the eligibility criteria for the abbreviated process are as follows.
Note that a significant change that includes consequential changes can be counted as one change, providing that all changes were assessed and approved by the overseas authority at the same time as one application (eg, a new finished product manufacturing site is consequentially registered as a finished product testing and primary packing site – all is considered one significant change).
Medsafe still reserves the right to re-route any application to the standard evaluation process if the application does not fulfill the intent of the abbreviated evaluation process.
The new eligibility criteria will come into effect on 1 July 2014
Section 2.4 of Part C of the New Zealand Regulatory Guidelines for Medicines will be updated to reflect this change.
Any questions relating to this consultation should be directed via email to Sarah_Reader@moh.govt.nz