Non-Clinical and New Approach Methodologies European Specialised Expert Community
HumanVeterinary
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.
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Role
The specialised expert community helps EMA identify experts in regulatory areas such as:
- innovative in vitro models such as 3D-cell culture models, organoids and microphysiological systems (MPS), including organ-on-chip technologies able to simulate the activities, mechanics and physiological response of an entire organ or organ system;
- human cell-based systems including those using induced pluripotent stems cells (iPSCs) that enable the use of human-based rather than animal-based models;
- qualification and / or validation and regulatory acceptance of new approach methodologies (e.g. performance standards, reference compounds);
- in vitro-in vivo extrapolation (IVIVE), referring to the transition from studies done outside living organisms (in vitro) to those done in living organisms (in vivo);
- alternatives to the use of animals in batch-release testing of human and / or veterinary vaccines, biologicals or biotechnology-derived products.
The specialised expert community aims to facilitate:
- interaction within the expert community and with other stakeholders to foster and harmonise the regulatory acceptance of new approach methodologies;
- knowledge-sharing and provision of training on non-clinical and new approach methodology topics;
- mapping related competencies across the European medicines regulatory network;
- connecting experts from multidisciplinary teams and across topics of expertise.
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.
Mandate, objective and rules of procedure
The specialised expert community's mandate is available below:
Composition
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.