EARLY ACCESS AND COMPASSIONATE use
There are in France two exceptional procedures which are designed to ensure equity of access and the greatest possible security for the use of medicines outside the existing regulatory fields previously known as Authorisation for Temporary Use (ATU) and Recommendation for Temporary Use (RTU) for off-label use drugs.
The French Social Security Financing Act (LFSS) for 2021 includes a flagship measure that came into force on 1st July 2021: the overhaul of the French "ATU and "RTU" early market access schemes.
| This measure, which aims to simplify applications, harmonise procedures, guarantee patients immediate access to treatments and finally improve the control of health expenditure, streamlines the pathways into two distinct routes: | |
EARLY ACCESSTo provide early access for drugs in clinical development with plans to submit for marketing authorisation. |
COMPASSIONATE ACCESSFor drugs for which the manufacturer does not intend to apply for a marketing authorisation for the indication. |
With 20 years of expertise in the management of named patient, cohort and extension cohort Authorisations for Temporary Use (ATU) and Off-label Use programs (RTU), ICTA is the partner of choice to advise you and assist you in the implementation and management of your future EARLY ACCESS or COMPASSIONATE ACCESS programs.
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Need assistance ? Do not hesitate to contact us: nadine.roumier@icta-group.com