Novel therapies

The Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT) of the European Medicines Agency's (EMA) Committee for Medicinal Products for Veterinary Use prepares scientific guidance on the requirements for authorisation of novel therapy veterinary medicines.

ADVENT is currently developing guidance in the form of question-and-answer (Q&A) documents in novel therapy related areas.

Novel therapies are therapies entirely new to veterinary medicine either because they are genuinely novel and have not been previously used in the context of a medicine, or new only to the veterinary domain, although well known in terms of research, and possibly in the context of human medicine.

ADVENT releases the problem statements for public consultation in order to identify further questions experts should consider in the respective subject areas. The feedback received will contribute to the development of the Q&A guidance.

ADVENT also welcomes suggestions on novel therapy related subject areas that would benefit from the provision of scientific guidance. Please send contributions to advent@ema.europa.eu

For a complete list of documents currently open for consultation, see Public consultations.

Guidance (questions and answers)

• Questions and answers on allogenic mesenchymal stem cell-based products for veterinary use: specific questions on tumorigenicity
• Questions and answers on allogenic stem cell-based products for veterinary use: specific questions on extraneous agents
• Questions and answers on allogenic stem cell-based products for veterinary use: specific questions on sterility
• Questions and answers on monoclonal antibodies for veterinary use

Problem statements

• Stem cell-based products for veterinary use: specific questions on target animal safety to be addressed by Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)
• Stem cell-based products for veterinary use: specific questions on tumorigenicity to be addressed by Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)