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Guidelines and Codes

Introducing an extended abbreviated evaluation process
(effective from 3 March 2008)

1. Introduction

From 3 March 2008, an extended business rule for abbreviating the new medicine evaluation process for eligible applications will be implemented. The extended rule replaces the abbreviated process available for high- and intermediate-risk prescription medicines that have been assessed and approved by the Therapeutic Goods Administration of Australia. A reduced fee will apply to applications that are evaluated under the new business rule.

To be eligible for the extended abbreviated process the application must be for a medicine that:

• has been approved by one of a range of recognised regulatory authorities prior to submission of an application to Medsafe; and
• is marketed in that country at the time of submission of the application

2. Application and evaluation process

Applicants seeking consent to distribute new high- or intermediate-risk prescription medicines then have the option of either:

• Seeking approval under the non-abbreviated process by submitting a full dataset for assessment as required by the Medicines Act 1981 and the New Zealand Regulatory Guidelines for Medicines with the full applicable fee; or
• Seeking approval under the extended abbreviated process by submitting a full dataset for assessment as required by the Medicines Act 1981 and the Medsafe Regulatory Guidelines, as well as the additional information specified in Section 5 below with the applicable (reduced) fee.

Medsafe will then undertake either a full assessment of the data provided, in the first case, or a streamlined abbreviated assessment based on evaluation of the additional reports, in the second case.

When making its abbreviated assessment Medsafe will ascertain if any aspect of the product poses any safety issues if used in the New Zealand market, before determining whether the product requires evaluation against any Medsafe specific evaluation requirements.

3. Recognised regulatory authorities

For the purposes of the extended business rule, Medsafe recognises the following regulatory authorities as being competent in applying the CPMP/ICH standards for the evaluation of medicines:

• Australian Therapeutic Goods Administration (TGA);
• United States Food and Drug Administration (FDA);
• Health Products and Food Branch of Health Canada;
• European Medicines Evaluation Agency (centralised procedure only); and
• United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA).

4. Eligibility criteria

To be eligible for the abbreviated evaluation process, the new medicine must be identical to the product originally approved by the recognised regulatory authority in all aspects i.e. manufacturing site, specifications, product indications, warnings and precautions, and packaging other than for specific labelling and packaging requirements such as a New Zealand classification statement¹. If changes have been made to product details since approval by the recognised regulatory authority, these will need to be handled through the Changed Medicine Notification process, prior to marketing of the product in New Zealand.

5. Required documentation

Applicants submitting applications for new medicines that meet the eligibility criteria will need to provide documentation describing the product and the history of the product's evaluation and approval by the recognised regulatory authority.

The following information, in the correct format, must be submitted:

1. A covering letter requesting that the application be evaluated using the abbreviated process;
2. A complete Module 1 completed specifically for New Zealand registration.
   
   Applicants should use the revised NMA application form - (Appendix 2A), posted on the Medsafe website.
3. A complete dataset as required by the Medicines Act 1981 and the Medsafe Regulatory Guidelines, consisting of Modules 2, 3, 4, and 5 (as applicable) previously submitted to the recognised authority for which approval is granted. This dataset should be in CTD format and may include revisions requested by the recognised regulatory authority during assessment.²
4. A table of contents for the dossier to provide easy reference to the submitted information;
5. A table which sets out the events in the regulatory history of the product occurring from the date of the application for consent lodged with the recognised overseas regulatory authority through to the date of the application for consent to distribute in New Zealand. This table will need to include information under at least the following headings:
   1. Date of the event;
   2. Event description (e.g. type of application, request for further information); and
   3. Brief description, in chronological order, of correspondence with the recognised regulatory authority (with dates, name and designation of author and summary of content).
6. A copy of the evaluation reports from a recognised regulatory authority that has approved the product;
7. A copy of requests for information issued by the recognised regulatory authority that has approved the product and the responses to such requests;
8. Evidence, if required, of the relevance of the submitted biostudy reference product to the NZ market reference product in line with Medsafe guidelines.
9. A copy of the approval letter and approved product details, including any attachments from the recognised regulatory authorities;
10. Evidence that the product remains on the market in the country overseen by the recognised regulatory authority³;
11. Finalised labelling and packaging copy from the recognised regulatory authority and proposed New Zealand labelling and packaging⁴.
12. A copy of the regulatory authority's approved drug substance specifications cross-referenced to the drug product manufacturer's test method number, or applicable pharmacopoeia reference number.
13. A copy of the regulatory authority's approved drug product release and expiry specifications cross-referenced to the drug product manufacturer's test method number, or applicable pharmacopoeia reference number.

Failure to clearly identify the required information as requested could result in delays in the processing of the application. Absences of any applicable information detailed above will likely lead to a 10-day request for omitted data.

6. Fees

The fee for an application for an abbreviated evaluation will be:

• $33,750 for a high-risk medicine;
• $16,875 for an intermediate-risk prescription medicine

There will be no charge for any additional strengths, names, dose forms, or flavours provided these are submitted as part of a single application.

There will be no change to the fee for an application for provisional consent.

7. Timeline for evaluation

Medsafe will complete the initial evaluation of products using the abbreviated process within 135 days of acceptance of the application. Subsequent evaluation of additional information will meet Medsafe's usual stated performance criteria.

8. Maximising the use of the abbreviated process

From 3 March 2008, all new applications for new high-or intermediate-risk prescription medicines will follow either the full or abbreviated evaluation pathways described above. Once evaluation has commenced the application will progress through the Medsafe process until the product has been approved, the application has been rejected, or the application has been withdrawn. Once evaluation has commenced, the applicant will not be able to change which pathway is used, nor will they be permitted to submit additional data for an application using the abbreviated process unless it is in response to a question from Medsafe.

9. Transitional issues

Applicants who have submitted applications prior to the start date for the abbreviated process, but for which evaluation work has not commenced, will have the option of following either the full or abbreviated evaluation pathway.

If applicants wish their application to follow the full evaluation pathway, then they will not need to do anything. Medsafe will process the application in the normal way.

If applicants wish their application to follow the abbreviated evaluation pathway, they will need to notify Medsafe of this in writing, prior to evaluation commencing on their application. The applicant will then have 90 days to provide the additional information required for the abbreviated process.

Attempts will be made by Medsafe evaluators to contact applicants, to offer the possibility of using the abbreviated evaluation process, prior to commencing evaluation.

The applicant should provide the required information for the abbreviated process, as described in points 1 to 13 in Section 5 of this document. Should the applicant wish to vary proposed product details in order to qualify for the abbreviated route of administration they may do so. This could possibly involve the submission of a different dataset (modules 2, 3, 4, or 5).

For applications submitted to Medsafe prior to August 2006 further fees may be required. For those applications received since August 2006 Medsafe will refund the difference in the fee minus an administrative charge of $400.

Medsafe will not screen the additionally provided information for completeness upon receipt. Absences of any applicable information will likely lead to a 10-day request for omitted data.

If evaluation of an application submitted before 3 March 2008 has already commenced, the application must follow the full evaluation pathway.

10. Post-implementation review

Medsafe will review the abbreviated evaluation process in September 2008. The review will determine whether the process requires further improvement or can be extended to other evaluation activities, such as evaluation of low-risk new medicines, and evaluation of changes to approved medicines.

11. Contact for Queries

The Team Leader of the prescription medicines team within the Product Regulation Branch of Medsafe is the contact for queries about the application of the extended business rule. The contact details are:

E-mail: Antony_fake@moh.govt.nz

Telephone: (04) 819 6839

¹ In the case of intermediate-risk prescription (generic) medicines the product indications, warnings and precautions etc must be identical to the NZ approved innovator product
² It is recognised that the dataset (mod 2, 3, 4, or 5) submitted for approval in other countries may not comply with all Medsafe specific technical requirements because of the overseas authority’s technical requirements. In such circumstances non-compliance may be permissible. It is recommended that such issues be discussed with the evaluator or Team Leader prior to submission.
³ Where a product has been approved by a recognised authority within 12 months of the application to Medsafe and the product is intended to be marketed, then use of the abbreviated process is permitted.
⁴ The product must comply with Medsafe's current labelling requirements.