Regulatory harmonization--a vaccine industry perspective

With growth and diversification of aquaculture has come the dissemination of diseases and the increased need to use control measures, both preventative and therapeutic. Preventative measures include good husbandry practices, adequate nutrition and the use of vaccines. Vaccines for aquaculture have generally fallen under the regulatory control of national veterinary medicinal or biological agencies and with that a diverse range of regulatory requirements for authorization and use. More so than any other food animal industry, aquaculture is an international industry with individual entities holding multinational ownership. This situation has created unique problems for the manufacturers of biologicals attempting to service the industry. In recent years, a concerted effort has been made to harmonize regulations to facilitate international trade of vaccines as well as vaccinated animal stocks and their processed food products within and among trading partners. Standardization of requirements for manufacture and testing would ensure national and international interests and consumers of pure, safe and effective products. As the path to harmonization has been slow and not without disagreements, the question remains: What will the standardized requirements be? The manufacturing philosophies of process control (Good Manufacturing Practice) and governmental final product testing for batch release can create a duplicity of effort on the part of the manufacturer that equates to higher economic costs and greater time constraints. The current lack of standardized quality control test methods often means conducting multiple tests to provide the same result. Although efforts are being made to recognize these differences, historical regulations today are based on injectable vaccines for warm-blooded animals. Administration of vaccine products to cold-blooded aquatic species by immersion, bath and oral routes, as well as by injection, creates interpretive problems for manufacturers and regulators alike. Industry encourages and awaits regulatory harmonization, standardization or equivalence. It also offers and would appreciate an active role in the final process.