Novel therapies

The Novel Therapies and Technologies Working Party (NTWP) 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.

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.

The Novel Therapies and Technologies Working Party (NTWP) is committed to providing and improving guidance on novel veterinary medicinal products.

The NTWP welcomes suggestions on novel therapy related subject areas that would benefit from the provision of scientific guidance. Please send contributions to [e-mail] 

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

Guidelines

• Risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products
• Development and data requirements of potency tests for cell-based therapy products and the relation to clinical efficacy
• Quality, safety and efficacy of bacteriophages as veterinary medicines

Concept papers

• Concept paper on quality, safety and efficacy of bacteriophages as veterinary medicines
• Concept paper for the development of a guideline on the safety of nanoparticles – in the context of the establishment of maximum residue limits and veterinary marketing authorisations

Questions and answers

• Questions and answers on stem cell-based products for veterinary use: specific question on target animal safety addressed by CVMP/ADVENT
• 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