Revised: 1 March 2010

Medicines

Medsafe's Evaluation Policy for Priority and Abbreviated Assessments

Please note that Medsafe has revised its policy regarding the response times for applications that have been approved for a priority assessment and applications for the abbreviated evaluation route.

Under the revised policy:

• Retention of priority assessment status is conditional on sponsors responding to requests for information within 28 days.
• Sponsors for applications being handled through the abbreviated evaluation route are to provide responses to requests for information within 28 days.
• Medsafe will evaluate sponsor responses within 28 days.

This revised policy was foreshadowed at an Industry liaison meeting in November 2009 and follows discussions with PHARMAC in relation to priority assessments for new generic medicines. Further background information and details of the implementation dates for the revised policy are set out below.

Priority Assessments

Medsafe will continue to grant priority status (upon application) on the basis of significant clinical advantage or significant potential cost savings for the tax payer.

The principle behind priority assessment is to shorten the time to consent and hence realise the potential of these new medicines. Medsafe uses internal processes to ensure that evaluation is commenced in a timely manner. If concerns are raised during the evaluation a request for further information is issued and applicants are currently granted 200 days to respond. This relaxed timeframe is not consistent with the goal of timely availability.

Under the revised policy (which will apply from 1 April 2010) the granting of priority assessment status will be conditional on applicants responding to a request for information within 28 days. If a sponsor considers that Medsafe's request cannot be responded to within 28 days, they should first contact the evaluator to ensure that the request has been correctly interpreted. In cases where the sponsor cannot obtain the information requested within the 28 day timeframe, it can still be provided after this deadline but the priority status of the application will be revoked.

Medsafe considers the 28 day response time to be reasonable as applications should be complete before lodgement. A further benefit of truncating the response time is that the application can be referred back to the original evaluator in most circumstances, with increased efficiency in concluding the evaluation.

Abbreviated Evaluation Route

Recently Medsafe reviewed the performance of the abbreviated evaluation route and concluded that the significant time savings envisaged were not being realised.

During its review Medsafe has made the following observations about factors which cause delays in concluding evaluation via the abbreviated route:

• The presentation of the product for the New Zealand market is not identical to the product that was approved overseas (e.g. formulation, manufacturing chain, shelf-life, product specifications).
• All evaluation reports, including responses to issues raised by the evaluator and any revised specification documents, are not provided.
• If changes to the medicine have been approved, evaluation reports and approval documentation are not supplied.
• The bioequivalence study does not use the appropriate New Zealand or Australian reference product or, alternatively, does not provide the necessary bridging studies to support an overseas reference product.
• Datasheets are not submitted in accordance with NZRGM guidelines.
• Letters of access to Drug Master Files are not provided.
• Labelling is not submitted in accordance with NZRGM guidelines.
• Current GMP certificates are not provided for manufacturing and packing sites.

Applicants are reminded that a complete application allows conclusion of an evaluation within a minimum timeframe.

Under the revised policy (which will apply to all requests for information issued after 1 April 2010) Medsafe will encourage more timely evaluation outcomes by undertaking to review applicant's responses to requests for additional information within 28 days, providing the applicant provides the information within 28 days.

In cases where the sponsor cannot obtain the information requested within the 28 day timeframe it can still be provided after this deadline but evaluation will be scheduled alongside applications undergoing full assessment (i.e. a 120 day evaluation deadline will apply).