The French National Agency for Medicines and Health Products Safety (ANSM) has released guidance on the development of shortage management plans for drugs of major therapeutic interest.
The ANSM launched a public consultation on the content of shortage management plans (PGP) for drugs of major therapeutic interest (MITM) in June 2021 to improve the availability of drugs in France.
ANSM recorded 37 contributions from healthcare professionals, patient associations and drug manufacturers, which enabled to finalize the guidelines for the development of PGPs by manufacturers.
France will require manufacturers of drugs of major therapeutic interest to have enough stock to supply the market for two months. ANSM can increase the stockpile to four months if a company has repeated supply problems.
The measures put in place by this decree make it possible to more effectively prevent stockouts of essential drugs marketed in France.
The decree notably provides for the preparation by manufacturers of shortage management plans (PGP) for all drugs of major therapeutic interest (MITM). These PGPs make it possible to prevent stockouts and, in the event of supply difficulties, to provide solutions as quickly as possible to ensure the continuity of treatment for the patients concerned.
Manufacturers will also have to build up a safety stock for all the MITMs they market in France.