On 16 February 2022, The Veterinary Medicines Directorate (VMD) and Ministry for Primary Industries (MPI) published a guiding document concerning the simultaneous review of veterinary medicines in the United Kingdom and New Zealand.
The ‘United Kingdom-New Zealand Regulatory Cooperation: Guidance on Veterinary Drug Simultaneous Reviews’ (the Guidance) aims to:
Grant simultaneous access to two global markets.
Expand treatment options and access.
Strengthen the global regulatory sphere by promoting knowledge and expertise-sharing.
Acknowledge and maintain decision-making sovereignty.
According to the VMD’s guidance,
"Simultaneous reviews permit manufacturers to submit a dossier to both regulators at the same time. The evaluation is conducted independently by each country in parallel, with the objective of issuing regulatory decisions at the same time."
The VMD also explain only certain products will be eligible. For example, it appears simultaneous review will only be available to applications "based on a full dossier". Further, the VMD and MPI have deemed generic medicines ineligible.
Significantly, the guidance describes distinct 'phases of simultaneous review', including: (1) ‘Pre-submission’; (2) ‘submission filing’; and (3) ‘submission review’. Ultimately, each regulator (VMD and MPI) will make a sovereign decision according to domestic law. Importantly, decision-making timing will be harmonised where possible.
In an accompanying media release, the VMD stress,
"The guidance represents an important step forward by expanding opportunities for industry to simultaneously access two major markets… It also supports our shared aim of expanding access to treatment options for animals and helping food producers stay competitive globally."
Whether the simultaneous review scheme will reduce regulatory burdens, harmonise timeframes, and alleviate applicants’ resourcing issues is unknown. Regardless, the scheme is an interesting development.
For further information regarding simultaneous review in the United Kingdom and New Zealand, read the VMD guidance here. Additionally, the VMD’s complementary media release may be accessed here.
It is crucial to stay up to date on global regulatory development to best meet your goals. Komply can help your organisation stay informed and attain success in its VMD and MPI submissions.
Komply advises and assists clients in end-to-end quality assurance, registration, regulatory, compliance, and commercialisation matters in human and veterinary applications.
Contact us directly at info@komplyaus.com for more information
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