[Regulatory aspects of the development, licensing, and availability of immunological veterinary medicinal products]

Vaccines constitute an essential tool for animal health management. In addition to applying traditional vaccine development strategies to new or changing pathogens, the use of innovative approaches in this area is increasing. Recombinant vaccines often have superior safety and efficacy profiles, due to their specific attenuation and the ability to serologically distinguish vaccinated from infected animals. The more detailed understanding of the immune system has also enabled the development of immune-based therapeutics, ranging from immunological castration to tumor therapy, and cell-based therapies for the treatment of cartilage or tendon injuries are increasingly used. In many of these cases, veterinary medicine applications provide important insights for future use in human patients. The associated regulatory challenges lie on the one hand in the integration of the innovative approaches in the existing national and EU legislative framework, and on the other hand in the development of appropriate criteria to evaluate their safety and efficacy. The promotion of innovative products has to be balanced with the safety of the target population as well as contact species and, in the case of food-producing animals, food safety. From the regulatory perspective, simplified licensing procedures represent an attractive alternative on the national level.