EMA publishes workshop report on requirements for the authorisation of vaccines
LONDON, 14-7-2015 — /EuropaWire/ — The European Medicines Agency (EMA) has published today the outcome of a workshop which explored how to ensure the availability of veterinary vaccines in the European Union (EU).
The availability of a wide range of veterinary vaccines is critical for the protection of animal health. Veterinary vaccines may protect human health, too, in those cases where they are used to prevent outbreaks of diseases in animals that can be transmitted to man, especially in animals that are intended for human consumption. Vaccines can also reduce the need for antibiotics, helping to stem the risk of antimicrobial resistance.
The workshop was jointly organised by EMA and Heads of Medicines Agencies (HMA) on 25 March 2015 and brought together experts from national competent authorities, the veterinary/pharmaceutical industry, and EMA. The participants examined the reasons why more veterinary vaccines are not currently available and discussed if the level of requirements for the authorisation 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 authorisation 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 whilst maintaining a high level of protection of animal and human health, and of the environment. These include:
- increase predictability of regulatory outcomes for applicants through early and/or enhanced engagement in the development of scientific and administrativeguidelines for veterinary vaccines;
- identify and propose specific training for regulatory assessors to enhance consistency of assessment and share experience;
- 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 authorisation;
- examine the factors identified by the industry as constraining the availability of vaccines within the EU;
- 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;
- Use the outcome of the workshop to enrich the discussions on authorisation 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.
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