Technical guidance and aide-mémoire on good manufacturing practice inspection of pharmaceutical manufacturing facilities with focus on reducing the incidence of antimicrobial resistance
Antimicrobial resistance (AMR) has been a health policy challenge for the past 75 years, although response has varied greatly over time, and between countries and regions. Every year at least 700,000 people die from drug-resistant infections. If AMR remains unchecked, the annual death toll could rise to 10 million people by 2050.
At the Sixty-eighth World Health Assembly in May 2015, Member States endorsed the Global Action Plan on Antimicrobial Resistance which espouses the one health approach to tackle antimicrobial resistance the most urgent threat to modern medicine.
The action plan includes a framework which calls for antibiotic-specific regulatory approaches and controls to curb AMR incidence and ensure safe and rational use of antibiotics. This underscores the need for regulators of medical products to play a key role in prevention and detection of AMR.