France's ANSM Announces Launch of Nine Regulatory Pilot Projects
Posted 29 October 2012 | By
French regulators have announced the results of an open call for regulatory projects aimed at improving the public health by improving how information is reported to patients and caregivers, how regulators investigate products with possible health risks to the public, and allowing patients to self-report adverse events to regulators.
The projects are among the first for the recently-formed National Security Agency of Medicines and Health Products (ANSM), which was formed after a reshuffling of the previous agency, the Afssaps. That agency's reputation was sorely damaged in the midst of a scandal involving the diabetes drug Mediator, which, despite being pulled from most markets for safety issues, had remained on the market for sale in France.
The new agency, ANSM, was given new authority to monitor adverse events and potential safety issues, and several of the selected projects seem to be aimed at boosting this new authority. Two separate projects, funded with a combined €76,000, will look at adverse events related to Gilenya (fingolimod) and diethylstilbestrol (DES) respectively.
Other projects are aimed better understanding how patients actually use regulated products, and whether their conditions merit special consideration by regulators. Two studies, funded with a combined €40,000, will assess behavioral disorders in Parkinson's disease and the difficulties associated treating patients with Dravet syndrome.
The final five projects are geared toward providing information to patients, such as how biotherapies work and using technology to inform treatment options and adherence.
The projects will launch in 2013 with deliverables due within 12 months.