Flash: A Pilot Phase for Extending the Shelf Life of Medicines

The “Ecological Planning of the Healthcare System” Roadmap, published by the steering committee established following the “France Nation Verte” initiative, outlines several objectives for controlling the environmental impact of the healthcare sector.

Extending the shelf life of certain medicines is among these measures, particularly to address the unnecessary destruction of thousands of boxes due to excessively short shelf lives.

The Legal Framework for Shelf Life

The majority of medicines authorized in France have a shelf life of 2 to 3 years. While this period is not subject to any regulatory limit, it is nevertheless subject to stability studies.

Stability tests evaluate the physical, chemical, biological, and microbiological characteristics that ensure the continued safety and efficacy of the medicine over a specific period and under specific storage conditions (temperature, light, humidity).

The duration of stability studies is established by the Marketing Authorisation Holder (MAH), who claims the shelf life in their MA dossier. This duration is approved by the competent authority based on the stability data provided.

None of the guidelines governing stability studies link shelf life to environmental impact by preventing the disposal of usable medicines.

A pilot phase for extending shelf life through a call for applications

Initial details regarding extending shelf life were outlined by the French National Agency for Medicines and Health Products Safety (ANSM) in its recommendation “Extending the shelf life of medicines to reduce waste and pollution,” published on November 21, 2025.

The ANSM is launching a call for applications, entitled “Long Life for Medicines,” for pharmaceutical companies wishing to request an amendment to the MA of at least one of their medicines within 5 years, in order to increase its shelf life.

This call for proposals is open from November 21, 2025, to March 20, 2026.

Laboratories must identify, from the application phase, the pharmaceutical products concerned (name, CIS, current shelf life, target shelf life, availability of supporting data, and anticipated date of submission of the amendment request).

Benefits and Commitments

Firstly, selected laboratories will receive support from the ANSM’s Innovation and Guidance Office for “eco-design and eco-production of medicines.” The ANSM also mentions “possible recognition within their corporate social responsibility initiatives.”

Secondly, upon submitting their application, laboratories must:

– confirm that the targeted products are marketed in France and that extending their shelf life is scientifically feasible, although it is possible to indicate that supporting data are not yet available ;
– commit to submitting applications for marketing authorization amendments within 5 years; and
– commit to participating in the annual project evaluation.

In addition, laboratories are invited to provide annual feedback on a voluntary basis, to help illustrate the benefits or limitations of the approach.

Next Steps

In parallel, the agenda for the ANSM’s Advertising Working Group meeting on December 2, 2025, will address the inclusion of drug expiration dates in advertisements. It will be important to observe whether advertising can raise awareness about reducing waste related to drug expiration dates.

In the Roadmap, this measure appears alongside other commitments concerning unused medicines (UMs), including the revision of the legal criteria for classifying UMs and the creation of conditions allowing their re-dispensing.

=> The development of the associated regulatory framework is therefore expected.