In recent years, activities in the field of gene therapy (GT) have increased markedly. Large numbers of clinical trial applications are submitted to regulatory authorities. The first gene therapy product has been granted a marketing authorisation for the European market and more may be available soon.
In order to prepare the OMCLs for their role in the surveillance of the quality of GT products, a specific Working Group has been established within the General European OMCL Network. The role of this Working Group is to foster collaboration between OMCLs working in the field of GT products in order to save time and resources by sharing knowledge and technologies.
Currently the following OMCLs participate in the Working Group:
- Austrian Agency for Health and Food Safety, Austria
- Scientific Institute of Public Health, Belgium
- Health Canada, Centre for Vaccine Evaluation, Canada
- Danish Health and Medicines Authority, Denmark
- Agence nationale de sécurité du médicament et des produits de santé - Direction des Laboratoires et des Contrôles – France
- Paul-Ehrlich-Institut, Germany
- Istituto Superiore di Sanità, Italy
- INFARMED I.P. National Authority for Medicines and Health Products, Portugal
- Medical Products Agency, Sweden
- Schweizerisches Heilmittelinstitut, Swissmedic, Switzerland
- National Institute for Biological Standards and Control, UK
The GT Working Group meets once per annum to review the activities of the past year and to define the work programme of the following year as well as to discuss any relevant topics.