France: ANSM Launches Pilot Project to Extend the Shelf Life of Medicines
The French medicines agency ANSM has published an update on its “Longue vie aux médicaments” pilot project aimed at extending the shelf life of medicines. Fourteen pharmaceutical companies responded to the call for applications. The project covers a total of 73 medicines, including commonly used products containing paracetamol, levothyroxine, melatonin or lithium.
Based on appropriate stability data, longer approved shelf lives will be sought for the participating medicines. According to ANSM, 47 of the 73 medicines could eventually achieve a shelf life of at least four years.
Through the pilot project, ANSM intends to support manufacturers planning to submit a marketing authorisation variation within the next five years to extend the shelf life of their medicines. The selected companies will receive scientific, technical and regulatory support from the agency.
Extending the shelf life of medicines is expected to reduce the disposal of unused products, improve medicine availability and reduce the environmental impact associated with their manufacture and destruction.
Source:
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
