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New EMA expert group to support veterinary novel therapies
The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has established a new Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT) aimed at providing more guidance on new classes of veterinary medicines, such as stem cell-based therapies or monoclonal antibodies.
This initiative is responding to a need expressed by industry and the regulatory network and is part of the Agency's efforts to support development of innovative medicines to further improve the health and wellbeing of animals. It follows the reinforcement in November 2013 of the Agency's Innovation Task Force to also provide support to novel veterinary medicines during the early stages of their development.
The expert group will provide guidance on the requirements for authorisation of veterinary novel medicines. These include therapies representing a novel concept or for which there is no experience in the veterinary area yet. The advice will be general in nature and will not be related to a particular application or product.
The CVMP will determine a list of priority topics for ADVENT. To draw up the list, the Committee will take into account recent feedback from stakeholders. These priority topics will be published on the EMA website within the work plan for ADVENT, to be agreed and published in early 2015.
ADVENT is composed of a small core group of six experienced regulators with broad knowledge on the regulation of veterinary medicines and additional specific knowledge relevant to quality, safety or efficacy of veterinary medicinal products. The group will be supported by additional groups of experts in a specific scientific area as required.
Members of the ADVENT core group were elected at the CVMP meeting in December 2014 and a chair will be elected at the CVMP meeting in January 2015.