Briefing meetings of the EMA Innovation Task Force now open to veterinary medicines
The scope of the European Medicines Agency's (EMA) Innovation Task Force (ITF) has now been extended to cover support to veterinary medicines during the early stages of their development. The ITF was initially set up for human medicines; however, innovation in the veterinary medicines field over recent years has demonstrated a need to make a similar process available for veterinary medicines.
The ITF is a multidisciplinary group that provides a forum for early dialogue with applicants, in particular micro, small and medium-sized enterprises (SMEs), to identify scientific, legal and regulatory issues relating to emerging therapies and technologies. It holds briefing meetings with applicants to cover issues arising in the development of innovative medicines or technologies, which are free of charge and facilitate informal information-exchange and the early provision of guidance in the development process.
Specific steps have been defined for applicants developing veterinary medicines who wish to request a briefing meeting, as endorsed by the Committee for Medicinal Products for Veterinary Use (CVMP) at its October 2013 meeting. The procedure involves the addition of an initial step to allow the EMA's veterinary medicines division to tailor the process to the specific request.
Instead of directly applying to the ITF secretariat, applicants for innovative veterinary medicines are therefore invited to send all potential applications for briefing meetings to: firstname.lastname@example.org.
This pre-step is favoured while the process is initially implemented for veterinary medicines until more experience is gained. In addition, many such requests are initially expected to be of a consultative nature rather than formal requests for ITF briefing meetings.