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Poster de conférence Année : 2023

Mapping regulators’ early interactions procedures to support innovation

Résumé

In an effort to help stakeholders to overcome the legal and scientific challenges raised during the development of a medicinal product, procedures, such as scientific advice, have been established in the European Union to enable early contact with regulators, especially in the field of gene and cell therapy. These procedures help to support innovation. They are various: some are available for all medicines and others target innovative medicines or Advanced Therapy Medicinal Products (ATMPs); some are legislative or regulatory schemes, others put into place services; some benefit to all types of medicines’ developer, others target a specific type of developer. These procedures for early interactions between stakeholders and regulators are available to facilitate communication between institutions and medicine developers all along the medicine’s life-cycle, but the main focus is on the pre-marketing authorisation phase. The exchanges occurring between regulators and the seeker of interaction can impact the chances an ATMP has to enter on the market. Thus, the aim is to foster their development by helping developers to navigate the regulatory pathways adequately for ATMPs to meet quality, safety, and efficacy requirements according to robust evidence to obtain marketing authorisation and access to patients. Knowing all the procedures, who can ask for them, which procedure to use, and with which regulator can be a challenge. Moreover, the extent of the possible support is often overlooked. This poster describes and discusses the multiple existing options available to ATMPs’ developers to overcome challenges during the pre-marketing authorisation phase through early interactions with regulators, here focusing on the European Medicines Agency and National agencies. Communicating on the early procedures available at national and European levels will help to identify potential gaps and raise developers’ awareness of the different procedures available to support the marketing authorisation of ATMPs.
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Dates et versions

halshs-04290584, version 1 (16-11-2023)

Identifiants

  • HAL Id : halshs-04290584 , version 1

Citer

Auxane Delage, Luc-Sylvain Gilbert, Hsin-Yu Kuo, Anna Couturier, Aurélie Mahalatchimy. Mapping regulators’ early interactions procedures to support innovation. European Society for Gene & Cell Therapy Congress 2023, Oct 2023, Bruxelles (BEL), Belgium. ⟨halshs-04290584⟩
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Dernière date de mise à jour le 28/04/2024
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