The European Medicines Agency (EMA) has published the outcome of a workshop that explored how to ensure the availability of veterinary vaccines in the European Union (EU). The workshop was jointly organized by EMA and Heads of Medicines Agencies (HMA) on March 25, 2015 and brought together experts from national competent authorities, the veterinary/pharmaceutical industry, and the EMA. The participants examined the reasons why more veterinary vaccines are not currently available and discussed if the level of requirements for the authorization of veterinary vaccines in the current legal framework is well balanced or might in some cases discourage potential applicants.
The workshop concluded that several factors combine to make the EU market less attractive for the authorization of vaccines than other regions, which might lead to a lack of availability of certain vaccines. The reasons for reduced availability are complex and multifactorial and differ depending on the type of vaccine concerned, such as vaccines for companion animals, for livestock, for treating major diseases, for treating minor diseases, or for treating outbreaks of epizootics diseases such as foot-and-mouth disease or bluetongue.
The workshop concluded with a series of recommendations intended to improve this situation. These included: (1) increase predictability of regulatory outcomes for applicants through early and/or enhanced engagement in the development of scientific and administrative guidelines for veterinary vaccines; (2)
identify and propose specific training for regulatory assessors to enhance consistency of assessment and share experience; (3) examine the feasibility of preparing lists of diseases for which vaccines are not available, and are therefore required, together with clear expectations of what would be needed for their authorization;
examine the factors identified by the industry as constraining the availability of vaccines within the European Union; take the opportunity of the ongoing revision of the guidelines on data requirements for products for minor use, minor species (MUMS) to explore the scope for further reduction of data requirements for this type of product; and use the outcome of the workshop to enrich the discussions on authorization of vaccines in the European Council and Parliament on revision of the legislation governing veterinary medicines.
This meeting report and its recommendations will form the basis for a joint EMA/HMA action plan to improve the availability of veterinary vaccines in the EU, involving industry and other experts in its preparation and implementation.
Source: European Medicines Agency