According to a meeting between the European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States’ Food and Drug Administration (FDA) hosted by EMA on 1-2 September 2016, configuration of data requirements by regulators worldwide can put in to motivate the development of new antibiotics to fight antimicrobial resistance globally and protect worldwide public health. Conversely, regulatory activities are only one factor of the inclusive and versatile response needed to support and step up development of new antibacterial medicines that meet patient needs.
The conclusions of the meeting will be presented at the G7 Health Ministers’ meeting, organized by the government of Japan in Kobe on 11-12 September 2016.
The three agencies also agreed in the meeting that some flexibility should be applied to the requirements for clinical development programs for antibacterial agents where treatment options for patients are partial due to antimicrobial resistance.
The participants discussed approaches to clinical trial design, including choice of endpoints, as well as post-authorization monitoring activities for antibacterial medicines.
They also recognized areas of closer alliance and harmonization of efforts to support the development of safe and helpful antibacterial treatments.
Date: 07/09/2016