The Society has presented a short submission on the Medicines Amendment Bill which currently stands referred to the Health Select Committee.
One of the changes proposed in the Bill would be a new verification pathway for medicines approval in Aotearoa New Zealand. The change would enable medicines to be approved within 30 days if the product already has approval from two recognised overseas jurisdictions. It lists nine approved overseas regulators that could be used for verification purposes.
However, the Society has raised strong reservations over whether this change is necessary and/or would be best practice.
Arguably having our own regulator making its own assessment of the submitted clinical and related data and providing an independent determination is the preferred approach.
The proposed verification system would require approval by two of the listed overseas regulators. The Society submission suggests if a verification process is to be used it would be safer to require approval by more than just two overseas regulators – perhaps require three or four.
Additionally, it would be important to check and ensure that the overseas regulator or regulators did not approve the medicine within their jurisdiction/s by verification.
It might also be prudent to limit approval by verification to exceptional circumstances only, such as emergency or short supply situations.
However another change in the Bill is supported by the Society. The Bill would amend the Medicines Act to a
nsnz submission on the medicines amendment bill.pdf
The Society has presented a short submission on the Medicines Amendment Bill which currently stands referred to the Health Select Committee.
One of the changes proposed in the Bill would be a new verification pathway for medicines approval in Aotearoa New Zealand. The change would enable medicines to be approved within 30 days if the product already has approval from two recognised overseas jurisdictions. It lists nine approved overseas regulators that could be used for verification purposes.
However, the Society has raised strong reservations over whether this change is necessary and/or would be best practice.
Arguably having our own regulator making its own assessment of the submitted clinical and related data and providing an independent determination is the preferred approach.
The proposed verification system would require approval by two of the listed overseas regulators. The Society submission suggests if a verification process is to be used it would be safer to require approval by more than just two overseas regulators – perhaps require three or four.
Additionally, it would be important to check and ensure that the overseas regulator or regulators did not approve the medicine within their jurisdiction/s by verification.
It might also be prudent to limit approval by verification to exceptional circumstances only, such as emergency or short supply situations.
However another change in the Bill is supported by the Society. The Bill would amend the Medicines Act to a
nsnz submission on the medicines amendment bill.pdf