September 7, 2016

EMA, FDA and PMDA discuss regulatory approaches for the evaluation of new antibacterial agents

Alignment of data requirements by regulators worldwide can contribute to stimulate the development of new antibiotics to fight antimicrobial resistance and protect global public health. However, regulatory activities are only one element of the comprehensive and multifaceted response needed to encourage and accelerate development of new antibacterial medicines that meet patient needs.

This was one of the conclusions reached at a meeting between the European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the FDA, hosted by EMA on September 1-2, 2016.

At their tripartite meeting, the three agencies also agreed that some flexibility should be applied to the requirements for clinical development programs for antibacterial agents, in particular where treatment options for patients are limited due to antimicrobial resistance.

In addition, participants reiterated that it may be appropriate to accept abbreviated clinical development programs for new antibiotics that can address an unmet need related to antimicrobial resistance.

With a view to better understand the similarities and differences between the clinical data requirements of the three regulatory systems, the participants discussed approaches to clinical trial design, including choice of endpoints, as well as post-authorization monitoring activities for antibacterial medicines.

They also identified areas of closer collaboration and coordination of efforts to encourage the development of safe and effective antibacterial treatments.

The conclusions of the meeting were presented at the G7 Health Ministers’ meeting, organized by the government of Japan in Kobe on September 11-12, 2016.

Related Links

• Meeting Summary: EMA, PMDA and FDA meeting to discuss regulatory approaches for the evaluation of antibacterial agents (September 1-2, 2016)(PDF - 34KB)[ARCHIVED]
• Antimicrobial Resistance Information from FDA