France less frequently chosen as rapporteur or co-rapporteur in EU drug filings

Pharmaceutical companies seem to be choosing France less often as a rapporteur or co-rapporteur country for European filings by the centralised procedure, according to the annual report of Afssaps, the French Health Products Safety Agency.

The report reveals that in 2007 France was the rapporteur or co-rapporteur in only 11% of European marketing authorisation applications submitted via the centralised procedure, which represents a considerable decline on the previous average rate of around 20% since 2003.

France was chosen as the reference member state in fewer mutual recognition or decentralised procedures in 2007. It was the reference state for 23 of the 160 of these procedures in 2007 (14%), compared with 26 out of 113 in 2006 (23%).

There were also fewer clinical trials submitted to Afssaps in 2007 - around 1,000 compared with 1,148 in 2006. Among the clinical trials conducted in 2007, 23% were in Phase I, 30% in Phase II (2006: 25%), 34% in Phase III, 11.3% in Phase IV and 1.6% were of undetermined stage (2006: 6%).

In terms of therapeutic area, 24% were for onco-hematology indications, 19% for central nervous system disorders, 9% for infectious diseases and 9% for cardiovascular diseases. Nineteen clinical trial applications for cell therapy products were filed (18 in Phase I/II and 1 in Phase III), as well as four for gene therapy product trials (3 in Phase I/II and 1 in Phase III).

Afssaps" annual report mentions a sharp decrease in the number of drug import authorisations: 7,302 compared with around 13,000 and 19,000 respectively in the two preceding years.

In terms of pharmacovigilance, the agency revealed that more than 20,000 adverse effects were reported by regional pharmacovigilance units. Half of the incidents were severe. Three-quarters of such notifications were reported by specialist physicians (84% in 2006), 7% by general practitioners (2%), and 14% by pharmacists (11%).