ANSM Aims for Better Surveillance, Enhanced Training

July 31, 2015

French health officials have promised to beef up surveillance of medical devices as part of a multi-year action plan released late last month.

Dominique Martin, director general of the Agence nationale de sécurité du medicament et des produits de santé, signed off on the plan that details four specific strategies to enhance health by 2018. These strategies are guaranteeing the safety of products throughout their lifecycle; promote rapid access to health products; encourage better communications with stakeholders; and make the agency more efficient and modernized.

The report, titled Contract D’Objectifs et de Performance, examines 12 targets and 22 specific actions the ANSM intends to take over this time period. The agency intends to focus on improving products by analyzing medical device data, monitoring clinical trial applications, examining advertising and obtaining information from other European competent authorities. It has promised to strengthen its inspection capabilities both in France and other countries.

In addition it will work with institutional partners to develop a common policy to exchange information on surveillance of products relevant to the agency. It will also ensure appropriate communications with healthcare professionals about the agency’s mission.

The agency is stepping up efforts to optimize the review of medical products. As part of that plan, it will work to train reviewers to ensure they have the appropriate scientific expertise and encourage employees to update their skills to review the dossiers of increasingly complex products.

To read the full report in French, visit http://www.fdanews.com/08-03-15-france-report.pdf.
— Elizabeth Hollis