Regulatory Approaches to the Development Programme for Medicines Used to Treat Infectious Diseases

• Main Authors: I. V. Lysikova, O. I. Basova
• Format: Article
• Language: Russian
• Published: OOO “Vashe Tsifrovoe Izdatelstvo” 2019-12-01
• Series: Ведомости Научного центра экспертизы средств медицинского применения
• Subjects: antimicrobial medicines; bacteria; preclinical studies; clinical studies; multiple drug resistance; efficacy; safety
• Online Access: https://www.vedomostincesmp.ru/jour/article/view/258
• ISSN: 1991-2919; 2619-1172

In February 2017 the World Health Organization first published the list of antibiotic-resistant «priority pathogens» — a catalogue of 12 species of bacteria that pose the greatest threat to human health. The list highlights the danger posed by Gramnegative bacteria that are resistant to multiple antibiotics. Thus, the development of new antimicrobial medicines is becoming a pressing issue. The list is an important reference point and incentive to secure and guide research and development related to new antibiotics that will help solve the issue of growing global resistance to antimicrobial medicines. The aim of the study was to determine the main regulatory approaches to planning preclinical and clinical development programmes for new antimicrobial medicines. On the basis of current requirements and recommendations in force in the Russian Federation and guidelines of the European Medicines Agency, the issues of planning antimicrobial drug development programs were considered. The autors analysed the main stages and aspects of preclinical studies of medicines for infectious diseases (specific activity in vitro and in vivo, PK-PD modeling), as well as requirements for the clinical trial stage, including the rationale for the choice of clinically relevant efficacy and safety endpoints, study design, and statistical methods.