Increasing the availability of veterinary vaccines in the EU
EMA-HMA action plan published along with new webpage
The European Medicines Agency (EMA) and its partners in the European medicines regulatory network, the Heads of Medicines Agencies (HMA), are implementing a joint action plan to help increase the availability of veterinary vaccines in the European Union (EU). This plan contains 13 concrete initiatives to facilitate timely access to the EU market for new or improved veterinary vaccines.
Veterinary vaccines protect animals against infectious disease and may also protect human health by ensuring safe food supplies and preventing animal-to-human transmission of infectious diseases, such as vaccination of chickens against salmonella to reduce contamination of the food chain. Vaccines can also contribute to the fight against antimicrobial resistance by reducing the need for use of antibiotics in animals. The availability of a wide range of veterinary vaccines is critical for the prevention and control of serious epizootic diseases such as foot-and-mouth disease and bluetongue.
However, there are recognised gaps in availability of vaccines against certain diseases and there is evidence that both the data requirements and time-to-market have increased within the EU over the last 15 years.The situation is particularly acute for minor use, minor species diseases - those which are rare in major species (such as Q-fever in cattle) or diseases that affect minor species such as goats or ducks.
In line with the EU Medicines Agencies Network Strategy to 2020, the action plan aims to bring together the regulatory activities of the European network to enable efficient and effective cooperation between all actors involved, including marketing authorisation holders, regulatory authorities and other stakeholders, in identifying and then implementing a range of measures specifically aimed at promoting the availability of vaccines in the EU.
This plan implements the recommendations from a workshop jointly organised by EMA and HMA on 25 March 2015 with experts from national competent authorities, the veterinary pharmaceutical industry and EMA. Participants at this workshop reviewed the requirements for the authorisation of veterinary vaccines within the EU and examined the reasons for the current lack of certain veterinary vaccines in the EU.
Information on this action plan, and more generally on ongoing initiatives and related activities to promote the availability of veterinary vaccines, is now available on a dedicated webpage. This page will be regularly updated and aims to help vaccine developers, and other interested stakeholders, to stay abreast of the most relevant information on this topic. The aim is also to open a dialogue with stakeholders, who are invited to submit suggestions by writing to firstname.lastname@example.org.
The issues around the availability of veterinary vaccines and the actions planned by the EU network are also summarised in a new video published today.