New Agency to Soon Replace French AFSSAPS
France has created a new agency, the National Agency for the Safety of Medicines and Health Products (MSNA), to replace its current regulatory agency, Afssaps.
The move was announced April 29 in France's Official Journal, which noted the new agency remains under development and the change will be effective in a few months.
MSNA will have a broader regulatory authority for monitoring and evaluation of health products, such as the development of independent research on product safety and requiring clinical studies against active comparators and placebo, Afssaps said in a statement.
The new agency will also have an operating budget greater than Afssaps (157 milliion Euros in 2012 vs. 125 million in 2010) and is financed exclusively by a state subsidy rather than through taxes or user fees from manufacturers.
Afssaps has been reeling from a series of scandals in recent months, including reports that the anti-diabetes drug Mediator was left on the market for a decade longer than was safe and its failure to stop defective breast implants manufactured by Poly Implant Prothese from being implanted into thousands of patients in France.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Patient Engagement Platform Checklist
November 22nd 2024Modern clinical trials are more complex than ever, and one significant reason is the increased focus on patient engagement. Incorporating a patient engagement platform into your clinical trial enhances the patient experience and can lead to more successful trials with stronger, more reliable outcomes. We put together this helpful checklist of key features to look out for when choosing a platform for your study.
