Report on the analysis of submissions received in response
to the consultation on the review of the abbreviated
Thirteen submissions were received on the consultation document.
As a result of the consultation Medsafe will making the following changes.
; The list of recognised regulatory authorities will be extended to include all
current EU member states
; Products that have changed since initial approval will also be eligible for
the abbreviated process providing that changes have been approved by
the same regulator who administered the initial approval.
; The restriction that products must be currently marketed in the authorising
country will be removed and replaced with an eligibility criterion that the
product must have been approved by a recognised regulatory authority
Further detail on the outcomes of the consultation is available in the following report on the analysis of submissions.
A total of thirteen submissions were received on the consultation document. The majority of submissions were from New Zealand based pharmaceutical companies. Two of the submissions were from organisations based in Australia with one from an Indian organisation. One submission was received from a New Zealand based government agency.
ANALYSIS OF THE SUBMISSIONS RECEIVED
Do you consider the rule should be extended to also apply to low-risk medicine applications?
Feedback was received from eight stakeholders. There was support for the extension of the process to include low risk medicines. Submitters indicated that the extension of the rule should be accompanied by a reduced fee, and definitive evaluation timeframes that were binding on both parties. Medsafe Comment
There is a lack of clarity and consistency in how low risk medicines are evaluated by other regulators compared to the requirements of the Medicines Act. In addition, as labelling forms a major component of evaluation of low risk medicines, extension of the rule is unlikely to reduce the cost or speed of the evaluation, as Medsafe will still need to ensure the product meets NZ labelling
requirements. Therefore, Medsafe does not propose to extend the rule to include low risk medicines at this stage. If an application includes an evaluation report from a Medsafe recognised regulator for the identical dossier, Medsafe will take this into consideration.
Do you consider the rule should be extended to also apply to changed medicine notifications (with appropriate adjustments to the required documentation)?
Feedback was received from twelve stakeholders. Eleven supported extension of the rule to apply to changed medicine notifications (CMNs); one on condition that this was accompanied by a reduced fee and definitive timelines for the evaluation period that are binding on both parties. One stakeholder felt they could not assess the value of this rule change without clarification of the timelines and costs associated with handling of CMNs under this rule.
Similar to the issues discussed above for low risk medicines, there is a lack of clarity and consistency on how CMNs are evaluated by other regulators. Furthermore, given that all CMNs are completed within 45 days of receipt of the application, there is unlikely to be any benefit in terms of improving the time taken to evaluate a CMN should the rule be extended. Therefore Medsafe does not propose to extend the rule to include CMNs. However, as for low risk medicine applications, if an evaluation report from a Medsafe recognised regulator for the identical dossier is available this could be supplied in the dossier and it will be considered as part of the evaluation of the product.
Recognised regulatory authorities –
Do you consider the list of recognised authorities should be extended? If so, which authorities should be added and why? And
Do you consider the caveat on recognising the European Medicines Evaluation Agency should be removed or amended, and if so, why? Feedback was received from ten stakeholders. Eight would like the list of recognised authorities extended, in the main to include regulatory approvals from any of the EU member states.
The abbreviated process currently recognises the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), and the European Medicines Evaluation Agency’s Centralised Procedure. The
general consensus was that the list of recognised authorities should include all or additional EU member states, and that, in addition to the Centralized Procedure, other procedures such as the National, Mutual Recognition, and Decentralised Procedures should be recognised. One submitter was of the view that Iceland (a non-EU member state) should be added.
Two stakeholders are of the opinion that the list of recognised authorities is adequate.
Medsafe proposes to extend the list of recognised regulatory authorities to include evaluation reports for all current EU member states providing the dossier is for an identical product, and that the product has also been approved through the Mutual Recognition or Decentralised Procedure. In addition to the normal requirements for an abbreviated application, details of the reason for and outcome of, any referral to arbitration by the Coordination Group for Mutual Recognition and Decentralised procedures (CMD(h)) should be included.
In extending the list of recognised authorities Medsafe places increased importance on the quality of the approved regulator’s evaluation reports that
are provided. Medsafe retains the right to request resubmission of the application through the full evaluation process should an application made via the abbreviated evaluation route be supported by regulator evaluation reports that do not adequately address all quality safety and efficacy issues. Eligibility criteria –
Do you consider that the rule should be modified to enable products which have changed since they were approved by the recognised authority to be eligible for the abbreviated process?
Feedback was received from twelve stakeholders
All who commented were of the opinion that the rule should be modified to enable products that have changed since they were approved by the recognised authority to be eligible for the abbreviated process. The general opinion was that the changes should be able to be included as part of the initial assessment.
The main reasons provided for supporting the suggested modification included reduced time to approval, reduced number of post-approval changed medicine notifications and improvement in product quality by ensuring that product that is approved is identical to the product marketed overseas. Six stakeholders are of the opinion that the changes should have been approved by the same recognised authority, whilst three submitters stated that the changes could have been approved by the same, or another, recognised authority.
Medsafe proposes to modify the rule to enable products that have changed since initial approval to be eligible for the abbreviated process. For a product to be eligible the change(s) must have been approved by the same regulator who undertook the initial approval. All approval documents, evaluation reports and questions and answers raised during the approval process should be submitted in addition to the material provided in the initial application. Medsafe understands that not all changes that are assessable by Medsafe are assessed by other international regulators. In such circumstances a CMN should be submitted to Medsafe following approval,
Required documentation –
Have you found it difficult to access any of the information sets described under sub-paragraphs I to xiii of paragraph 5 in Appendix 1? If so, why?
Nine stakeholders have found it difficult to access information required for the abbreviated process. Two of these stated that they are able to access the required information for TGA approved submissions and one also stated that this was also the case for MHRA approved submissions.
One stakeholder has not had any problems accessing any of the information sets.
The most common difficulty referred to was accessing evaluation reports, with four stakeholders commenting on this.
The main reasons provided for the difficulties experienced were problems obtaining the documentation from the recognised authority and problems obtaining the documentation from overseas affiliates or the overseas license holder.
There were some suggestions that Medsafe should obtain the supporting documentation.
Medsafe recognises that it may be difficult to obtain the required documentation however, it is also apparent that the difficulties encountered varied by stakeholder. Medsafe considers it the applicant’s responsibility to
ensure that all supporting documentation for an application is present in a dossier. Medsafe is not able to assist in obtaining documentation for the dossier.
Do you have any views on other forms of evidence of approval by a recognised authority that applicants wishing to use the abbreviated process could readily obtain (for example, an EPAR or PAR).
The majority of the six stakeholders who provided feedback on this point were supportive of the recognition of PARs and EPARs; however some concerns were expressed regarding the accessibility of these documents. Medsafe Comment
Whilst public assessment reports are readily available for some products approved in certain geographies they are unlikely to contain sufficient data to meet the current standards necessary to enable Medasfe to recommend consent to distribute a medicine in New Zealand.
Barriers to the uptake of the abbreviated process.
Feedback was reveived from ten stakeholders.
The main barrier identified was the requirement for the product to be marketed in the authorising country for it to be eligible for the abbreviated process. There were also concerns that the time to approval for products evaluated in the abbreviated process may not be reduced, or take longer if an
applicant waits for an overseas approval prior to lodging an application in New Zealand.
Medsafe recognises that the requirement the product is marketed in the country overseen by a recognised regulatory authority has been a barrier. Medsafe proposes to remove this restriction but restrict eligibility for the abbreviated evaluation process to products that have been approved by recognised regualtory authorities since 2001 in order to ensure that the dossier and historical assessment is consistent with current standards.
GENERAL COMMMENTS ON THE ABBREVIATED PROCESS.
Stakeholders who commented were generally supportive of the abbreviated process, reduced time to approval and the reduced application fee were seen as the major positives.