Selection of Medicines for Monitoring

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Chapter: Pharmacovigilance: PEM in New Zealand

In NZ, drug applications submitted for licensing are considered by the Medicines Assessment Advi-sory Committee (MAAC), which is advisory to the Ministry of Health.


SELECTION OF MEDICINES FOR MONITORING

In NZ, drug applications submitted for licensing are considered by the Medicines Assessment Advi-sory Committee (MAAC), which is advisory to the Ministry of Health. The MAAC has traditionally made the recommendations for which drugs should be moni-tored. For each drug recommended, the Director of the IMMP would undertake a feasibility study that would then be considered by an expert panel with a final recommendation then made to the Ministry of Health. The panel gave priority to monitoring those drugs where the conditions in Table 25.1 applied.


At the time of writing, no new medicines are being recommended for monitoring by the IMMP. One reason for this is the planned merger of the NZ and Australian medicines regulatory bodies and their advisory committees in 2007. Proposals for how the new Joint Tasman Agency will monitor the safety of new medicines is currently under development and is anticipated that the IMMP will continue to perform targeted post-marketing studies on selected medicines.



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