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Consultations

Published: 21 May 2014

Outcome of consultation on the proposed revision of the abbreviated process policy

About the consultation

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:

  • is approved by one of a range of recognised regulatory authorities prior to submission of an application to Medsafe and
  • was approved by a recognised regulatory authority in the five years preceding the application to Medsafe.

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).

Submissions received

Five submissions were received, and the following issues were raised.

  • There was general support for a process that delivers timely and efficient processing of applications.
  • There was concern that the five year eligibility criterion is too restrictive.
  • Clarification of the acceptance criteria for older dossiers was requested.
  • A concern was raised that there is not a transition period.

Consultation feedback

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.

New Business Rule

From 1 July 2014, the eligibility criteria for the abbreviated process are as follows.

  1. The medicine must:
    1. be an an Intermediate-risk or High-risk medicine that has been approved by a recognised regulatory authority since 1 January 2001
    2. not be subject to any regulatory action that may result in a suspension or revocation of the market authorisation by any recognised regulatory authority
    3. have the same formulation as the product originally approved by the recognised regulatory authority
    4. have the same dosage and indications as the product originally approved by the recognised regulatory authority (does not apply to generic medicines)
    5. have current market authorisation issued by the recognised regulatory authority
    6. have undergone NO MORE THAN TWO of any of the following types of significant change and those changes must have been approved by the recognised regulatory authority:
      • significant changes in method of manufacture considered as a "Finished product manufacturing process – Grade 2" Changed Medicine Notification
      • addition of a new finished product testing site
      • addition of a new finished product manufacturing site
      • addition of a new active ingredient manufacturing site for which a Drug Master File is required
      • addition of a new primary packing site
      • extension of shelf-life (multiple extensions will be considered as one change as subsequent changes supersede earlier ones).
  2. The original dossier submitted to the overseas authority must be in Common Technical Document (CTD) format and the dossier (submitted to Medsafe) must have been updated to incorporate the supporting data for any changes approved by the recognised authority.
  3. The overseas evaluation report(s) must correspond to CTD structure and must be a complete record of the assessment (redacted reports are not acceptable).
  4. Evidence of approval by the recognised overseas authority of the medicine and any of the above significant changes to it, is included in the application to Medsafe. Such evidence in relation to applications from Europe can be in the form of either a marketing authorisation or notification from the authority of either a closed Centralised Procedure, Mutual Recognition Procedure, or Decentralised Procedure.

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.

Implementation

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.

Enquiries

Any questions relating to this consultation should be directed via email to Sarah_Reader@moh.govt.nz 

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