A Global Fight Against Antimicrobial Resistance
Regulatory agencies meet to discuss approaches to the development of antibacterial agents.
The European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) met on Sept. 1–2, 2016 to discuss a worldwide regulatory response to the development of new antibiotics to fight antimicrobial resistance. The agencies agreed at the meeting, which was hosted by EMA, that regulatory activities were only one facet of the response needed to fight antimicrobial resistance worldwide.
Approaches to clinical trial design and post-authorization monitoring activities for antibacterial medicines were discussed in the meeting. The agencies agreed that requirements for clinical development programs for antibacterial agents should be flexible, specifically where treatment options are limited because of antimicrobial resistance. Meeting participants stated that accepting abbreviated clinical development programs for new antibiotics that address unmet needs may be appropriate.
A summary of the meeting can be found on EMA’s website, and the results of the meeting will be presented at the G7 Health Ministers’ meeting on September 11–12, 2016.
Source: EMA
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
