Poster Abstract
Genes, cells, and tissues based medicinal products are specifically regulated as Advanced Therapy Medicinal Products (ATMPs) within the European Union (EU) from the adoption of Regulation (EC) n°1394/2007 on ATMPs. Beyond legislative requirements, the complexity and scientific technicity of these medicines, as well as the necessary flexibility to take into account the evolutions and the scientific and regulatory experience gained has led to the development of an important amount of guidelines in the field. These guidelines have mainly been adopted by the European Medicines Agency (EMA), the European regulatory agency especially in charge of the scientific assessment of medicines to be commercialized in the EU. Some of them have also been adopted by the European Commission which grants the final marketing authorization for medicines to enter the EU market. The adoption of EU guidelines involves a public consultation procedure to gather comments from stakeholders and interested parties.
Our poster aims at mapping these different actors, and their potential changes over time, to allow for a realistic and concrete portrait of all stakeholders and interested parties involved in the field of ATMPs regarding their European regulation through guidelines.The identification of EU scientific guidelines applicable to ATMPs, and of the actors involved in the consultation process has led to the establishment of a database with over 200 organizations corresponding to fourteen guidelines for which dates of production range from 2008 to 2022. The organizations have been classified by type (Business, Academia, National bodies, etc.), country, and theme of the drafts of guidelines they commented on.This poster especially highlights and discusses which organizations have influenced the adoption of EU scientific guidelines on ATMPs; some of them commenting almost all guidelines in the field while others considered only certain guidelines.Findings concern both the number and quality of stakeholders with the aim to understand over time, what types of organizations from which country have been the most active in answering to guidelines’ consultations, who were the major or more prolific respondents, and what themes were more often commented.
Poster
Source: Mahalatchimy, A., and V. Brunel. "711 - Regulatory Affairs, Quality Systems, Policy, and Ethics: Which Actors to Influence the Adoption of Eu Guidelines for Advanced Therapy Medicinal Products?". Cytotherapy 25, no. 6, Supplement (2023/05/01/ 2023): S161. https://doi.org/https://doi.org/10.1016/S1465-3249(23)00435-8.
The PDF file of this poster can be downloaded in the attachment section below.