Regulatory
Rapporteur
Write to the Editor at publications@topra.org
June 2025 | Vol. 22 | No. 6
EDITORIAL
Veterinary medicines: Translating regulation into practice
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. This has led to the development of a new regulatory framework to address the specific characteristics of the veterinary industry. In this issue, we explore Veterinary Regulation 2019/6, and discuss regulatory opportunities and challenges for the sector.
By Kornelia Grein
FOCUS
Veterinary Regulation 2019/6: Impact, challenges and the future
In this interview with Ivo Claassen, Head of the Veterinary Medicines Division and Deputy Executive Director of the European Medicines Agency (EMA), he reflects on the impact of the Regulation, including the new tools created to foster innovation, reduce administrative burdens and antimicrobial resistance, the challenges faced in implementation and potential future developments for the industry.
By Kornelia Grein of KGVetMedConsultancy and Jana Schalansky of the European Medicines Agency (EMA)
FOCUS
New European Medicines Agency fees: The effect on veterinary medicines
The European Medicines Agency introduced a new fee system on 1 January 2025 to cover the costs of service provision for veterinary medicines, which were previously subsidised. This article outlines the impact of these changes on marketing authorisation holders, including those supplying veterinary medicines nationally without a centralised marketing authorisation, the consequences for products marketed only in one Member State and the implications of referral procedures.
By Dr J Gabriel Beechinor of the Health Products Regulatory Authority (HPRA), Ireland
FOCUS
Promoting the use of bacteriophages in animals to reduce antimicrobial resistance
There is increasing interest in the use of bacteriophages in human and veterinary medicine as part of the global battle against antimicrobial resistance, but the regulatory and commercial challenges differ widely between the two sectors. This article describes the main regulatory challenges for developing bacteriophage-based products for use in animals and presents an analysis of the key messages from a recent International Alliance for Biological Standardization (IABS) meeting that may interest regulators and manufacturers who are keen to promote the use of phage products in animal husbandry and food production to reduce antimicrobial resistance (AMR).
By David Mackay of the International Alliance for Biological Standardization (IABS-EU)
STANDALONE
Sandbox of trust: Regulated AI for health promotion and disease prevention
By 2042, a large increase in the global centenarian population is predicted, and with this continued increase in age longevity comes higher demands for health services. This article looks at how artificial intelligence-driven big data capabilities, based on personal electronic health records and in the form of digital healthcare tools, can counterbalance the impact of ageing and increased human longevity, and transform the future of the European health landscape. It discusses UK and EU projects to test and validate AI use of data in public health systems and calls for the need for AI guardrails and trust.
By Catarina Carrão of BioSciPons
STANDALONE
Divergence on the definition of regulatory reliance in international regions: Is there room for convergence?
Reliance pathways, in the form of collaborative, regional, unilateral and mutual recognition, hold a unique position for regulatory strategists, as they offer a simplified and more efficient process for new marketing authorisation applications (MAAs). This article summarises AstraZeneca analysis of available regulations using reliance pathways and a proposed reliance pathway classification to streamline strategic considerations for use in MAAs.
By Asya Tyurikova, Neal Ladwa and Anna Litsiou of AstraZeneca
STANDALONE
Medical device standards update
This edition of our regular column updates the progress of applicable standards for medical devices and in vitro diagnostic devices up to May 2025.
By Charlotte Holleran of Endomagnetics Limited
If you’re interested in veterinary medicines, find out more about our upcoming Veterinary Medicines Symposium from 29-30 September 2025 in Berlin, Germany.
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