ANSM updates list of critical medicines

The National Agency for Medicines and Health Product Safety (ANSM) has updated its list of major therapeutic interest medicines (MITM) on October 5, 2026. These are medicines or classes of medicines whose interruption could significantly impact a patient's health or represent a major loss in treating serious diseases.

List now includes 7,855 medicine presentations

The updated list contains 7,855 different medicine presentations, with 345 new additions representing 4.39% of the total. These changes occur due to new medicines entering the market, others being removed, and updates from laboratories. Companies that market medicines must report to the ANSM any that meet the MITM criteria.

Five main therapeutic classes added

The 345 new presentations are grouped into five major therapeutic classes. Antineoplastics and immunomodulators include 79 presentations, such as Calquence 100 mg in film-coated tablet and Stelara 45 and 90 mg in prefilled pen. Hematology and hematopoietic organs include 60 presentations, such as Enoxaparin Venipharm and Rivaroxaban Biogaran.

Other therapeutic areas include nervous system and anti-infectives

The nervous system category includes 58 presentations, such as Modafinil Zentiva 100 mg and Clozapine EG Labo 25 and 100 mg. Systemic anti-infectives include 38 presentations, such as Amoxicillin Viatris Santé 1 g in dispersible tablet and the pneumococcal vaccine Prevenar 20. Cardiovascular system has 34 presentations, including Digoxin Nativelle 0.25 mg and Amlodipine Cristers 5 mg.

Other classes include diverse therapeutic areas

The remaining 76 presentations are spread across various therapeutic areas, including the digestive tract and metabolism, with medicines such as Metformin EG Labo and Rowasa. Other areas include the respiratory system, with Xolair 75 mg, and ophthalmology with Ikervis. The additions also cover genitourinary systems, antiparasitics, and the "diverse" class, including Ventizolve.

MITM listing brings specific obligations

Being listed as a MITM imposes specific obligations on laboratories. They must develop plans to manage potential shortages and ensure treatment continuity. A minimum safety stock of two months is required for MITM intended for the French market. In some cases, the ANSM may increase this to four months, especially if there are supply issues or risks of recurring shortages. Exceptions can be made under regulated circumstances.