EMA revises guidance on testing anti-bacterial medicines
Follows concern that existing advice was insufficiently comprehensive
The European Medicines Agency (EMA) has released revised guidance on testing the safety of anti-bacterial pharmaceuticals following concern that existing advice was insufficiently comprehensive.
The new guideline says that microbiological evaluations should include efforts ‘to identify the precise mechanism of action’ involved in a chemically active ingredient.
Because of concern about anti-bacterial resistance, the EMA also wants assessments to examine a pharmaceutical’s effect on pathogens known to withstand similar medicines. It added that clinical tests should ‘select patients with infections…that require antibacterial therapy’ using the delivery method of the medicine under examination. Each clinical benefit should be tested by ‘at least two randomised and controlled studies’.
Meanwhile, examinations should be sufficiently staggered to pick up side-effects such as severe skin reactions and antibiotic-associated diarrhoeal disease.