Regulatory requirements for veterinary vaccine stability in the European Community

The regulatory criteria of quality, safety and efficacy for any medicinal product must apply throughout its shelf-life to ensure it remains fit for its intended use. The methods and evaluation criteria for determining the stability characteristics and shelf-life of immunological medicinal products may differ from those of pharmaceuticals as a result of their heat-sensitive nature and complexity. The range of species and diseases for which veterinary immunological medicinal products may be used has resulted in differences between the regulatory requirements for human and veterinary products. The European Community requirements for the stability data needed to support an application to place a product on the market differ from those of the United States Department of Agriculture. The value of accelerated stability testing is discussed in relation to applications for Marketing Authorizations and variations thereof. The need for harmonization is increasing as pharmaceutical companies move to expand into the world market. Regulators are faced with many issues on which opinions differ, or have yet to be formed. Advances in understanding stability parameters will be essential if agreement between regulatory authorities on testing requirements is to occur. Even if the researcher, pharmaceutical company and regulator ensure the product has an appropriate shelf-life, the storage conditions employed by the user may negate the efforts made.