Novel veterinary medicines – how to make use of stem cells and monoclonal antibodies
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Problem statements released for public consultation
The European Medicines Agency (EMA) is seeking feedback from its stakeholders on possible issues encountered when developing new veterinary medicines based on stem cells or monoclonal antibodies. Stakeholders are invited to comment on two problem statements that discuss questions around the development of veterinary medicines using these new technologies by 15 May 2016. Comments should be sent by this date to vet-guidelines@ema.europa.eu using the provided.
In view of the shift in the development of veterinary medicines towards more innovative and advanced technologies, there is a need for specific guidance on the use of technologies new to the veterinary domain to support innovation. The outcome of the consultation will be the starting point for the development of future guidance for these types of innovative veterinary medicines, building also on the experience gained so far with these technologies in human medicines.
Improving the health and wellbeing of animals by stimulating the development and availability of veterinary medicines is one of the Agency's key priorities. As part of this, the Committee for Medicinal Products for Veterinary Use (CVMP) set up the Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT), which has authored the two problem statements.
Stem cells are cells that can develop into different types of cell and can act as a repair system for the body for regenerating and healing damage. Monoclonal antibodies are structurally complex substances that can locate and bind to specific molecules in the body.