Tripartite meeting held between the EMA, Food and Drug Administration (FDA) and Pharmaceuticals and Medical Devices Agency (PMDA) to discuss regulatory approaches for the evaluation of antibacterial agents

• Date:
  Úterý, 24 Září 2019, All day
• Místo konání:
  European Medicines Agency, Amsterdam, the Netherlands

This fourth tripartite meeting between the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) discussed further alignment on clinical trial designs for key indications for antibacterial drugs for which convergence has not yet been reached. They agreed that data from contemporary clinical trials would be pivotal in defining the most suitable way forward. They also expanded the discussions to include antifungal agents, an area which is also affected by growing antimicrobial resistance and where clinical development programs can be challenging.

The agencies discussed:

• methods to facilitate obtaining paediatric clinical data and utilisation of modelling and simulation. Paediatric development is an important aspect in the development of anti-infective products;
• differences in test methods and derived interpretive criteria for susceptibility testing in the European Union, Japan and the Unites States. To facilitate multi-regional anti-infective medicine development, communication and collaboration among scientific and public health bodies involved in such activities are key and options for harmonisation are strongly encouraged;
• clinical trial considerations for new treatment modalities such as monoclonal antibodies and other non-traditional therapies for the treatment and/or prevention of infectious diseases. The need to work together to facilitate new approaches and to aim for convergence was recognised.

The agencies plan to meet again in 2020. They also plan to publish the outcome of their discussions, for example, in a scientific journal.
 

Documents

Meeting summary - EMA, Food and Drug Administration (FDA) and Pharmaceuticals and Medical Devices Agency (PMDA)