Developing an innovative health product often means addressing key regulatory questions at a very early stage:
What is the appropriate regulatory status for the product? Which development strategy should be pursued? Will the proposed data meet regulatory expectations? How should the next stages of development be prepared?
To support project developers, the French National Agency for the Safety of Medicines and Health Products (ANSM) has set up the Innovation and Orientation Office (Guichet Innovation et Orientation – GIO).
A gateway for innovative projects
The GIO enables project developers to contact the ANSM upstream of regulatory procedures and benefit from scientific, technical, legal and/or regulatory support for the development of innovative health products, including:
- medicinal products;
- medical devices (MDs);
- in vitro diagnostic medical devices (IVDs).
The objective is to enable early dialogue with the Agency, while certain scientific or regulatory choices can still be discussed before they are implemented.
When should you contact the GIO?
The GIO may be particularly relevant when a project raises a specific regulatory issue or uncertainty that could have an impact on its development.
Depending on the product and the situation, discussions may cover:
- regulatory qualification or classification;
- development strategy;
- scientific or technical questions;
- qualification of a research project;
- preparation of a clinical investigation or performance study;
- specific regulatory questions ahead of a future procedure.
The aim is therefore to identify, at an early stage, the issues that may influence the next steps of the project.
What is the difference between the GIO and pre-submission?
The GIO intervenes at an early stage, while development is still ongoing and key scientific or regulatory questions remain to be addressed.
Pre-submission takes place at a more advanced stage, when the strategy has already been defined and submission of the regulatory dossier is approaching.
The choice between the two therefore depends primarily on the maturity of the project and the nature of the questions to be addressed to the ANSM.
Preparing effectively for discussions with the ANSM
The value of a GIO request depends to a large extent on how well it is prepared.
The key is to turn a general regulatory issue into targeted questions that enable a constructive and useful discussion with the authority.
Atessia supports you
Atessia supports healthcare stakeholders in their interactions with regulatory authorities and in defining their regulatory strategy.
When approaching the GIO, we can support you in analysing your regulatory strategy, identifying the questions to be submitted to the ANSM, preparing the request and discussions with the Agency, and analysing the feedback received.
Are you developing an innovative health product and considering contacting the GIO?
Contact us to discuss your project: hello@atessia.fr
Article written by Estelle Icard Regulatory Affairs & Pharmaceutical Consultant