Non-Clinical and New Approach Methodologies European Specialised Expert Community
Human
Veterinary
The European Medicines Agency's (EMA) Non-Clinical and New Approach Methodologies European Specialised Expert Community is a platform for information-sharing and interactions between experts in the non-clinical field, including on new approach methodologies.
It supports EMA's two working parties in the non-clinical domain, namely the 3Rs Working Party (3RsWP) and Non-clinical Working Party (NCWP).
It is overseen by EMA's Committee for Medicinal Products for Human Use (CHMP) and Committee for Veterinary Medicinal Products (CVMP).
New approach methodologies may help reduce the need for animal testing in predicting efficacy and safety with human medicines. This can support the "3Rs" principles of ethical animal use in scientific research and development.
More information:
The specialised expert community helps EMA identify experts in regulatory areas such as:
The specialised expert community aims to facilitate:
The specialised expert community does not contribute to any regulatory procedures or actions related to product-related scientific evaluations or scientific guidelines. It does not give advice or take decisions.
Individual members may contribute to EMA’s scientific work as members of scientific committees, working parties or drafting groups.
The specialised expert community's mandate is available below:
The specialised expert community is composed of European experts with a special interest or expertise in the areas of non-clinical testing and new approach methodologies. They are selected from within the European medicines regulatory network and academia (e.g. research institutions or universities).
Members are nominated by a member of one of EMA's scientific committees (CHMP, CVMP, PDCO, PRAC, CAT or COMP) or Scientific Advice Working Party (SAWP). Membership is endorsed by CHMP and CVMP.
All members have signed a public declaration of interests and confidentiality undertaking form.