The-NZ-Initiative-Research-Note-Safe-to-follow-Faster-access-to-medicines-for-Kiwis-v

The lack of published detail around the reason for Medsafe’s rejection of certain drugs means that we have not been able to determine whether they were a result of safety issues or the inefficiency of the approval process. [...] The COVID-19 pandemic and its social and economic impact on New Zealand, and subsequent rollout of the vaccination programmes, has further highlighted the need to examine the efficiency and efficacy of the approval process. [...] Medsafe will evaluate the application and present it to the Ministry of Health to further assess whether to grant consent for the medicine to be marketed in New Zealand. [...] Medsafe reviews the risks and benefits of each specific medicine to ensure that the safety profile is acceptable (i.e., the benefits of the medicine outweigh its risks). [...] Regulatory reliance, on the other hand, may be less costly and time consuming, but is dependent on the extent to which the processes of the ‘trusted agencies’ are rigorous and not reliant on other agencies down the chain.