The new expedited verification pathway is now in force, allowing Medsafe to accelerate medicine approvals while maintaining robust standards for safety, quality and effectiveness.
From today, medicines that have already been approved by two recognised overseas regulators can be considered for assessment through the streamlined verification pathway.
Medsafe Group Manager, Chris James says the initiative reduces duplication and supports timely access to medicines for patients.
‘This allows New Zealand patients to more quickly benefit from medicines that have already been rigorously assessed by overseas regulators,’ Chris James says.
‘The verification pathway allows Medsafe to build on those assessments, while continuing to ensure that medicines supplied in New Zealand meet the requirements of our regulatory system.’
The pathway recognises approvals from regulators in Australia, the United States, Canada, the United Kingdom, the European Union, Singapore and Switzerland.
Rather than repeating a full assessment, Medsafe will verify that the medicine proposed for New Zealand is the same as the product approved overseas and assess any factors relevant to its use in the New Zealand context.
The streamlined process is expected to improve the efficiency of medicine approvals while maintaining appropriate safeguards. Medicines assessed through this pathway will still undergo regulatory scrutiny and have to meet certain eligibility criteria. Any applications that require more detailed consideration can continue to be evaluated through existing assessment pathways.
‘The verification pathway aligns us with the approaches taken in other countries such as Singapore and the United Kingdom, while allowing us to maintain New Zealand’s independent decision-making,’ Chris James says.
Several pharmaceutical companies have signalled interest in submitting applications for their products through the verification pathway, and Medsafe has begun to have conversations with companies about options.
‘Our focus is on making use of trusted international assessments and supporting faster access to important medicines, while ensuring people can continue to have confidence in the safety and effectiveness of medicines available in New Zealand.’
