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Regulatory Rapporteur

 

June 2025  |  Volume 22  |  No. 6

 

The June issue of Regulatory Rapporteur focuses on veterinary medicines.

Over the years, it has become apparent that the needs of the veterinary sector differ substantially from those of the human sector in relation to medicinal products. These variations include, for example, the many different animal species in the veterinary sector and the consequences arising therefrom in relation to marketing authorisations, the much lower prices for veterinary medicinal products in relation to products for human use, and the size of the animal pharmaceutical industry, which is only a small fraction of the size of the pharmaceutical industry for medicinal products for human use. This has led to the development of a new regulatory framework to address the specific characteristics of the veterinary sector, resulting in Regulation 2019/6.

This issue of Regulatory Rapporteur looks at the detail of the Veterinary Regulation 2019/6, and includes an interview with the Head of the European Medicines Agency (EMA) Veterinary Medicines Division on its impact and the challenges encountered in its implementation. It also includes an article on the new fee system for veterinary medicines, and a discussion on the use of bacteriophages and their potential to reduce antimicrobial resistance development. Focusing on other topics, this issue also provides an article on AI-driven predictive health risk assessments, an analysis of the divergence of regulatory reliance pathway terminology, and our biannual medical device standards update.

June cover image licensed

In his interview with Claire McDermott, Ivo Claassen, Head of the Veterinary Medicines Division and Deputy Executive Director of the European Medicines Agency (EMA), reflects on the impact of ‘the Regulation’. He addresses, among other things, the new tools created to foster the innovation of new medicines, and reduce administrative burdens and antimicrobial resistance development, the challenges that had to be overcome in implementing this piece of legislation and potential future developments.

A new fee system for veterinary medicines came into effect in January 2025 with fees being levied by the EMA. The impact of this on marketing authorisation holders, including those supplying veterinary medicines nationally without a centralised marketing authorisation, are described by Dr J Gabriel Beechinor, Director of Veterinary Sciences at the Health Products Regulatory Authority (HPRA) in Ireland. The new fees include charges for new applications, annual maintenance and pharmacovigilance, with specific provisions for small and medium-sized enterprises.

Bacteriophages are considered a valuable tool in the prevention, therapy and control of bacterial infections and their wider use in veterinary medicines would be of great value in the battle against antimicrobial resistance. However, their practical use in veterinary medicine poses many regulatory challenges. In our third article, David Mackay gives an analysis of these challenges, based on discussions at a conference by the International Alliance for Biological Standardization (IABS) in November 2024.

Moving to other areas of interest, our fourth article by Catarina Carrão of BioSciPons looks to the future, and the continued increase in age longevity and demands for health services. She reports on UK and EU projects to test and validate AI use of data in public health systems for the promotion of health and disease prevention and discusses the need for AI guardrails and trust.

There are various efforts for facilitated regulatory pathways for new marketing authorisations of medicines on global, regional or bi-/multilateral agreements. In our fifth article, Asya Tyurikova, Neal Ladwa and Anna Litsiou of AstraZeneca describe the challenges faced by regulatory strategists due to inconsistencies in terminology despite WHO recommendations, and call for a streamlined approach to regulatory reliance classification.

Our final article this month, by Charlotte Holleran of Endomagnetics Limited, gives an update of applicable medical device standards, to May 2025.

I hope you enjoy this issue.

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