Advanced-therapy medicinal products (ATMPs) are medicines for human use that are based on gene therapy, somatic-cell therapy or tissue engineering. They offer groundbreaking new opportunities for the treatment of disease and injury.
The regulatory framework for ATMPs is established in Regulation (EC) No 1394/2007.
These pages provide information for applicants on:
- the classification of ATMP marketing-authorisation applications;
- certification of the quality of ATMPs;
- non-clinical data submitted by small and medium-sized enterprises (SMEs) developing ATMPs.
Support to companies
The Innovation Task Force (ITF) provides a forum for informal dialogue between the European Medicines Agency and companies or individuals in the early stages of the medicine development process.
In addition, the Agency can provide support to companies through:
EDQM and EMA joint meeting on raw materials used for the production of cell-based and gene-therapy products - 3 April 2013
Council of Europe’s European Directorate for the Quality of Medicines and Healthcare (EDQM) and European Medicines Agency are bringing together users and manufacturers of raw materials and other interested parties to discuss issues of mutual interest and to exchange experiences. This will enable the Raw Materials for the Production of Cellular and Gene-Transfer Products Working Party to develop quality requirements for these raw materials for inclusion in the European Pharmacopoeia.
- European Union regulation on advanced therapies
- ATMP classification
- Certification procedure for small- and medium-sized enterprises
- Marketing-authorisation application submission
- Scientific guidelines
- Risk management
- Interested parties
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