In a groundbreaking development, Switzerland’s Swissmedic and the UK Veterinary Medicines Directorate (VMD) have embarked on a joint initiative in the veterinary medicines landscape. Since May 2023, companies in the life sciences sector have the opportunity to submit applications for the authorization of veterinary medicinal products and for new uses of existing products to both Swissmedic and VMD concurrently. This simultaneous review process signifies new regulatory cooperation between these two prominent authorities. Instead of pursuing separate tracks for authorization, applications will now be assessed independently yet simultaneously. This innovative approach not only promotes efficiency but also capitalizes on the collective expertise and resources of both regulatory bodies and the industry.
Key to this new procedure is the harmonization of time limits and schedules. The dual review process is conducted in close collaboration, based on identical dossiers and adhering to the same timeframes. This synchronization is aimed at encouraging decisions are reached in a coordinated and efficient manner. While Swissmedic and VMD maintain their autonomy in granting authorizations, and the procedure allows for differences in product labeling, the synchronized decisions open the door to parallel market access.
The core objective of this collaboration is to facilitate swift access to safe veterinary medicinal products. By leveraging the strengths of each authority and minimizing redundancies, this approach is poised to accelerate the availability of crucial treatments for animals, benefiting both animal health and the industry that serves it.
For companies seeking to engage in this program, the joint Guidance on Veterinary Medicines Simultaneous Reviews, valid from July 18, 2023, outlines the intricacies of the collaborative process and complements the existing legal and regulatory frameworks in Switzerland. Identical guidance has been implemented in the UK. The guidance provides a roadmap for companies navigating this novel path and illuminates the steps involved in preparing and submitting applications for veterinary medicinal product authorization. Furthermore, it offers insights into the evaluation criteria and standards applied by both Swissmedic and VMD, ensuring that companies can align their submissions with the expectations of both regulatory bodies.
The simultaneous review process is intended to offer several benefits to companies:
- Enhanced efficiency: The dual review process streamlines authorization, potentially reducing the time required for products to enter the market.
- Optimized resource allocation: Companies can allocate resources more effectively by engaging in a single, collaborative process rather than managing parallel tracks for authorization.
- Market access to two major markets: Simultaneous approvals in Switzerland and the UK pave the way for rapid market entry in both regions, facilitating international expansion.
- Accelerated benefits to animal health: Ultimately, the most significant beneficiaries of this collaboration are animals themselves. Swift access to safe and effective veterinary medicines contributes to improved animal health and well-being.
In conclusion, the simultaneous review of applications for the authorization of veterinary medicinal products by Swissmedic and VMD marks an important step in regulatory cooperation. However, close cooperation between the regulators will be necessary to ensure that the initiative achieves its objectives, without introducing additional complications and delays. Provided there is effective cooperation between the regulators and that the inevitable compromises can be swiftly reached where necessary, this new program provides an exciting opportunity to accelerate access to new veterinary medicines in both countries.
