ANSM provides COVID-19 clinical trials update

The ANSM (the French Medicines Agency) has provided an update on the clinical trials currently approved for products treating COVID-19.

The ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) is the key body in charge of authorising clinical trials in France.

The body has been extremely busy with applications for trials since the emergence of the coronavirus pandemic, and it has sought to speed-up its usual processes. Most trials are being sponsored by academic promotors.

ANSM says:

“In order to respond to the urgency of the situation, we therefore assessed the requests within an average time of 7 days against 60 days according to regulatory deadlines.

“From the start of the pandemic until April 10, 52 requests for authorisation for clinical trials were submitted to us.

“After analysing the files, more than 2 out of 3 projects have already been authorised. Certain files are the subject of requests for additional information or modifications.

“Among the trials submitted, 19 relate to hydroxychloroquine and chloroquine – 13 have already been authorised.

“The other authorised clinical trials mainly concern:

  • antivirals (remdesivir, ritonavir/lopinavir)
  • antibiotics (azithromycin), corticosteroids
  • converting enzyme inhibitors/sartans
  • or on monoclonal antibodies (immunomodulators)”

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Published on 21. April 2020 in News, News France, Press Release