Single development programme for new antibiotics in the EU, US and Japan

The United States’ Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) have taken further actions to align their approaches to the evaluation of antibiotics. The aim is to develop an approach that would allow drug manufacturers to conduct a single development plan for new antibiotic treatments to tackle antimicrobial resistance and safeguard global public health.

A third meeting between the three regulatory agencies was held in Kyoto, Japan, on 24th October 2017 where they discussed the progress made in their collaboration. The goal is a single development programme for new antibacterial medicines that can satisfy the regulatory requirements of each of the three agencies.

Aligning the agencies’ expectations for new products is expected to reduce the amount of duplicative work drug manufacturers will need to carry out, consequently lowering the cost of development for some antibiotics.

Action points that were discussed at the meeting:

  • Significant progress was made in discussions about further aligning clinical trials designed to study the effects of new antibiotics for certain indications, for example, urinary tract infections and uncomplicated gonorrhoea.
  • The agencies were in alignment on “the importance of adequately characterising pharmacokinetic and pharmacodynamic relationships, particularly for drugs that are developed to address serious infections with unmet need.”
  • The agencies agreed that a priority is collecting relevant clinical data for paediatric patients and streamlining the development of new paediatric antibacterial agents.
  • Monitoring risk-benefit throughout the lifecycle of a product, especially for drugs approved based on a more limited clinical programme, was identified as a key activity.

The three regulatory agencies plan to meet again in 2018 to continue their harmonisation efforts and help fight antimicrobial resistance.

To read more about the single development programme for new antibiotics in the EU, US and Japan, please click here.