The French National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé, ANSM) has published their annual report for 2014.
Key numbers from 2014
- In 2014 the ANSM approved:
- 33 cohort Temporary Authorisations for Use (ATU)
- 3 temporary use recommendations (RTU) regarding Baclofene, Roactemra and Remicade
- 576 Marketing authorisations
- more than 6,300 variations (see Le Moniteur des Pharmacies, in French)
- ANSM registered and evaluated quality defects in 1700 medicinal products, 2,525 medication errors, more than 70,000 undesirable effects and 699 laboratory inspections on site (14% was unexpected)
- In 2014, 438 declarations of shortages or risks of shortages were sent by pharmaceutical companies to the ANSM, representing a 10-fold increase in this activity in the past 5 years. The main products concerned were doxycicline, Di-Hydan, Claventin, Mantadix.
- In 2014, 12,111 patients were treated with medicinal products under cohort ATU representing 2-fold increase compared with 2013 and 18,831 patients under nominative ATU (12,822 patients with initiation of treatment).