April 2021: France Regulatory Update

An article France: Key institutions pledge to make clinical trial results public was published by TranspariMed, on April 06, 2021.

Along with the statements regarding the intention of making clinical trials public from the 5 largest medical research institutions in France, the article has information concerning a letter from the National Agency for Medicines and Health Products Safety (ANSM) to Transparency International France. The French regulator has noted in this letter to sanction a fine of 15,000 Euros or up to a year in prison in a case of non-compliance of publication of clinical trial results once the European Union regulation fully comes into force.

It has been also highlighted by TranspariMed that it is not yet clear if these sanctions will be directly imposed by ANSM or through a court. Additionally, ANSM did not specify whether an inspection process is in place to monitor sponsors’ compliance with their trial reporting obligations, or if there are plans to do so in the future.

Click here for the original article.

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