France further clarifies scope of clinical trial rules
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By two orders and one decree adopted respectively on 3 and 9 May 2017, the French government has further clarified the scope of the clinical trial rules in France (see previous updates: France aligns clinical trial rules with EU Clinical Trial Regulation, and France advances towards alignment with EU Clinical Trial Regulation).
Under the revised French framework, three categories of research exist:
- Interventional "trials on humans" (previously known as "biomedical research"), which require a favourable opinion from an ethics committee (EC) and authorisation from the National Agency for Medicines and Health Products Safety (ANSM).
- Low-intervention trials, defined as "trials with minimal risks and constraints", which in principle only require a favourable opinion of an EC.
- Non-interventional studies, for example, for example observational study on treatment adherence, which also in principle only require a favourable opinion of an EC.
The decree adopted now defines "trials on humans" as research on healthy or sick volunteers aimed at "developing biological or medical knowledge" in order to assess: (i) the functioning mechanisms of the human organism; or (ii) the efficacy and safety of products for the purpose of diagnosing, treating or preventing certain pathologies. It excludes certain research from its scope, in particular research on cosmetics and food products, and certain research with a public health interest.
The decree also simplifies the application procedure for an EC opinion for certain types of non-interventional research, and confirms earlier ANSM guidance in respect of sponsors' reporting obligations for any new fact that may affect the safety of healthy volunteers.
One of the orders adopted establishes a revised list of low-intervention trials, taking into consideration the age and condition of the subject and the frequency and duration of interventions. A second order establishes a list of non-interventional trials on cosmetic and food products that do not require a prior EC opinion.
The Clinical Trial Regulation (Regulation (EU) No 536/2014) will only govern interventional trials with medicinal products; other interventional trials and non-interventional trials remain subject to French law.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, May 2017 issue (Thomson Reuters).
This post was originally co-authored by Patricia Carmona Botana.