French Regulators Set Up Dedicated Unit for Overseeing Early Stage Clinical Trials
France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) last week announced that it is setting up a new unit dedicated to overseeing first-in-human and other early stage clinical trials.
The new unit is part of ANSM's action plan created in response to an incident during a first-in-human trial in France that left one patient dead and five others hospitalized in early 2016. The incident sparked an investigation by ANSM and a led to the European Medicines Agency (EMA) revising its guideline on identifying and mitigating risks in first-in-human and early clinical trials.
ANSM says the new unit will be housed within its Division of Authorization and Innovation Policies, and will oversee all first-in-human and early stage trials for drugs that "generate initial knowledge in humans on tolerability, safety, pharmacokinetics and pharmacodynamics for medicines." ANSM notes that the unit will not oversee studies of other products such as cell and gene therapies, human cell and tissue-based products, vaccines or medical devices.
The unit will handle all procedures relating to such studies for national procedures for French approval and for EU voluntary harmonized procedures.
In its announcement, ANSM provides instructions for conducting email correspondence with the new unit, referring sponsors to its recommendations for formatting emails in its Practical Information Guide for Applicants: Clinical Drug Trials submitted within the Pilot Phase to ANSM and the CPP (French Ethics Committee. ANSM also says that the phrase "PREC" should be added to the subject of all emails intended for the new unit to ensure they are dispatched appropriately.
Additionally, ANSM says it will update its Notice to Applicants of Clinical Trials on Medicinal Products Including Clinical Trials on Advanced Therapy Medicinal Products (ATMP) – Medicinal Product Trial Implementation and Procedures in France in February 2018 and an update to its Notice to Applicants on Vigilance of Clinical Trials is also forthcoming.