Veterinary Clinical Trials: New EU Law & Global Approaches
Clinical studies are intended to advance animal health care by identifying the most effective therapies and practices for a given condition, or by advancing our basic understanding of the disease. Much like a clinical study in the human population, a veterinary clinical study involves research that gains information from animal patients.
The current requirements and procedures for granting a marketing authorisation for veterinary medicinal products are laid down primarily in Directive 2001/82/EC and in Regulation (EC) No 726/2004. The new Regulation (EU) 2019/6 on veterinary medicinal products (VMPs) has been published on January 7th, 2019, to come into force on January 28th, 2022. The main aim of the new legislation is to increase the availability of VMPs in the EU, to improve the function of the EU market, to reduce the administrative burdens, and to strengthen innovation. This new Regulation has a new short Article 9 dedicated to veterinary clinical trials.
Approaches to Veterinary Clinical Trials
There are several ways to approach and perform veterinary clinical trials. By having multiple investigational sites, the potential bias can be largely overcome. In addition, it is preferable to “blind” a study such that those involved cannot distinguish the identity of treatments (or controls) being administered. In veterinary clinical trials blinding by function is often used – where the diagnosing and evaluating investigator is not involved in treatment administration, and this methodology is well accepted by veterinary regulators. Performing a trial that recruits patients from different regulatory jurisdictions can have major regulatory and economic advantages.
Simplified Marketing Authorisation Assessment
The new regulation brings a simplified marketing authorisation application assessment with respect to veterinary medicinal products of major interest, in particular in terms of animal health and therapeutic innovation. Further, the new legislation provides for an extended data protection period of technical documentation of 10, 14, or 18 years, depending on the type of VMP. These measures intend to stimulate the development of new VMPs, for example for rare diseases.
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