Medsafe Accelerates Medicine Approval Process, Seymour Calls for Further Reforms

The data highlights major efficiency gains, particularly in the assessment of new and generic medicines, as well as over-the-counter medications.

Associate Health Minister David Seymour has announced that Medsafe, New Zealand's medicines regulatory agency, has significantly improved its approval process timelines, according to recently released annual performance statistics for 2023/2024. The data highlights major efficiency gains, particularly in the assessment of new and generic medicines, as well as over-the-counter medications.

According to Minister Seymour, Medsafe has notably reduced assessment times across multiple categories:

Innovative New Medicines (high-risk): Evaluations completed, on average, 55 working days faster than in the previous period.

Generic Medicines (intermediate-risk): Evaluations completed, on average, 45 working days faster.

Over-the-Counter Medicines (low-risk): Medsafe achieved a 100% success rate in meeting timeframe targets, including for medicines like pseudoephedrine, which can now be purchased over the counter under specific conditions.

Innovations in Streamlined Processes

Seymour credited Medsafe’s adoption of a risk-based approach for certain medicines, particularly pseudoephedrine. Following a recent law change allowing pharmacist-only sales without a prescription, Medsafe used a rapid, tailored review method to approve 11 low-risk pseudoephedrine products in just 15 working days, ensuring timely availability ahead of the winter season.

“These improvements demonstrate Medsafe’s ability to deliver faster assessments, but further streamlining is essential for New Zealanders to receive the access to medications they need,” said Seymour. “We want Medsafe to build on this progress by exploring additional bespoke pathways and applying innovative processes where suitable.”

Future Pathways for Faster Approvals

As part of the ACT-National coalition’s commitment to expedite access to essential medicines, the government plans to introduce a new verification pathway. Under this new approach, Medsafe would approve pharmaceuticals within 30 days if they have already been approved by at least two internationally recognized regulatory agencies.

The proposed changes, according to Seymour, will help address the growing demand for new medications without compromising on safety. "Our priority is a regulatory system that grants New Zealanders prompt access to the medicines they need to lead fulfilling lives,” he said. "By embracing more flexible approval pathways, we aim to ensure faster, reliable access to critical pharmaceuticals.”

Ongoing Improvements and Industry Consultation

Seymour also underscored the importance of consulting with industry experts, healthcare providers, and patient advocacy groups to refine Medsafe’s processes and ensure efficiency in approval systems. In addition to adopting the new verification pathway, Medsafe is expected to explore further regulatory innovations aligned with international standards.

With public and private sector input, these enhancements aim to make New Zealand’s regulatory framework more adaptive and responsive, ensuring that crucial medicines can reach patients without undue delays.