The EDQM is the Directorate of the Council of Europe responsible for supporting the basic human right of access to good quality medicines and health care in Europe. With its European Pharmacopoeia (Ph. Eur.), the EDQM sets requirements for the quality of medicines, including those in the field of Gene Therapy Products (GTPs). Activities in the field started in 2000 with the creation of the Ph. Eur.’s GTP Working Party whose work led to the publication of general chapter 5.14 “Gene transfer medicinal products for human use” in 2006. In March 2018, the Ph. Eur. Commission decided to reactivate this Working Party and entrusted it with the revision of general chapter 5.14 to take into account more recently elaborated pharmacopoeial texts such as general chapter 5.2.12 “Raw materials of biological origin for the production of cell-based and gene therapy medicinal products”, and to assess the need to revise other general chapters or elaborate new Ph. Eur. texts related to gene therapy to include the latest developments in this fast-moving area.

See also the Summary of recommendations.

Read the Press Release.