Animal Health Products: Regulatory Framework
How does the regulatory framework governing veterinary medicines affect the animal health industry
Animal health products are subjected to exhaustive testing in the course of their development. Requests for permission to market a veterinary medicine are granted by independent regulators only when they are satisfied that the product has demonstrated required levels of efficacy, safety and quality.
Positive and encouraging legislative and economic environments, in conjunction with regulatory processes that safeguard consumers, are vital to ensuring innovation and availability of animal medicines which protect both animal and human health.
HealthforAnimals fully supports the application of rigorous, predictable, proportionate, science-based regulatory standards to all veterinary medicines. Legislation must be proportionate and be applied consistently to support a sustainable, innovative industry capable of delivering new products and technologies that address the needs of animals and their owners.
Existing problems stem partly from the tendency to apply common regulations to both human and veterinary medicines, ignoring major differences in terms of product requirements, the conditions under which they are used and – crucially – the gulf in resources that exists between the two industries. This trend has imposed a growing, often unnecessary burden on the animal health industry. HealthforAnimals pursues a constructive approach towards tabling proposed solutions to current problems and works alongside regulators to improve procedures and standards.
- See the brochure ” Promoting a positive environment for veterinary medicines “
- See also the paper on Global Regulatory Strategy for Veterinary Medicines.
- See also the document on ‘Essentials of veterinary pharmacovigilance‘
Adherence to common standards at a broader, global level is required in order to protect the health of both animals and consumers, and to ensure the availability of safe, high quality animal health products. International bodies such as
VICH and the Codex Alimentarius Commission are at the heart of HealthforAnimals’ effort to globally harmonise regulatory approaches to veterinary medicines.
The tripartite VICH is an initiative through which industry and regulators from the EU, the US and Japan have defined and implemented a series of harmonised regulatory guidelines.
HealthforAnimals and its members are also active participants in the work of Codex Alimentarius, which has developed a range of harmonised food safety standards impacting on the regulation of animal health products. These have been adopted by many smaller countries which may lack the resources required to generate their own national standards.
Key regulations have been simplified and harmonised in a number of markets as a result of HealthforAnimals’ work but the federation continues to pursue further improvements. It has turned its attention to issues such as product identification, and to the provision of incentives for innovation through appropriate protection of data linked to the registration of animal health products.
The website Vetmed.World is a global resource center that offers trainings, guidelines, templates and examples of good regulatory practice to assist in development of sound regulatory systems for veterinary medicines.
Materials cover topics such as regional harmonization, market authorizations, pharmacovigilance and more. The materials are selected as examples of good regulatory practice from around the globe, but particularly from Items come from independent experts in leading systems (ex. USA, EU, Japan, Australia, Canada and more) and international bodies like WHO, VICH and the World Organisation for Animal Health (OIE).
All resources are free and publicly available.