Regulators in EU, Japan and US take steps to facilitate development of new antibiotics
EMA, PMDA and FDA align data requirements and agree on areas of convergence
The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States' Food and Drug Administration (FDA) have agreed to align their data requirements for certain aspects of the clinical development of new antibiotics in order to stimulate the development of new treatments to fight antimicrobial resistance and protect global public health.
Representatives from the three regulatory agencies met in Vienna on 26-27 April 2017 and discussed recommendations for the design of clinical trials that test new treatments for certain types of bacterial infections, including infections caused by multi-drug resistant organisms. They identified a number of areas where the data requirements in the three regions could be streamlined.
EMA, PMDA, and FDA will be working to update their guidance documents respectively. While the updates are ongoing, they will provide advice to individual medicine developers in line with the agreements reached.
This tripartite meeting in Vienna followed an initial meeting that took place at EMA in September 2016 where the agencies discussed regulatory approaches for the evaluation of new antibacterial agents.
Stimulating and facilitating the development of new antibiotics, in particular those targeting multidrug-resistant pathogens, is one of the three pillars in EMA’s approach and European Commission's priorities to fight antimicrobial resistance.
Responsible use of existing antibiotics both in humans and animals to limit the development of resistance and preserve the efficacy of medicines for future generations, and the collection of robust data on antibiotic consumption, in particular in animals, to inform antimicrobial policies are the other two pillars.
- Second tripartite meeting held between EMA, PMDA and FDA to discuss regulatory approaches for the evaluation of antibacterial agents (26-27/4/2017)
- Tripartite meeting between EMA, PMDA and FDA on regulatory approaches for the evaluation of antibacterial agents (1-2/9/2016)
- Antimicrobial resistance
- Partners and networks: United States
- Partners and networks: Japan
Latest News from
A Europe that protects: good progress on tackling hybrid threats17/06/2019 16:37:00
The EU and Member States have made good progress in tackling hybrid threats through a number of concerted actions in a wide range of sectors to significantly boost capacities, shows the latest report adopted by the EC and the European External Action Service.
European Semester 2019 Spring Package and EU budget 202017/06/2019 16:07:00
The EC has presented the 2019 country-specific recommendations, giving economic policy guidance to all EU Member States for the next 12 to 18 months.
Delegated & implementing acts: EU adapts a significant number of legislative acts to the Lisbon Treaty17/06/2019 15:25:00
The Council has adopted a regulation aligning 64 legislative acts which refer to the so-called 'regulatory procedure with scrutiny' with the Lisbon Treaty.
The EU strengthens rules on home-made explosives and fight against terrorist financing17/06/2019 14:38:00
The Council has adopted two important priority files under the Security Union which strengthen EU rules on explosives precursors and facilitate law-enforcement access to financial information.
EU adopts regulation to keep unsafe products off the market17/06/2019 13:25:00
The EU is stepping up efforts to ensure that only products that are safe & compliant with EU legislation can be placed on the market.
Clean Mobility: EC tables proposal on car emissions testing in real driving conditions17/06/2019 13:03:00
In response to a ruling by the General Court, the EC proposes to reinsert certain aspects of Real Driving Emissions testing (RDE) into legislation to be adopted by the European Parliament and Council.
The EU and the United States reach an agreement on imports of hormone-free beef17/06/2019 12:25:00
The EC has shared with Member States the successful outcome of the negotiations to review the functioning of an existing quota to import hormone-free beef into the EU.
EU reports on progress in fighting disinformation ahead of European Council17/06/2019 11:38:00
The EC and the High Representative report on the progress achieved in the fight against disinformation and the main lessons drawn from the European elections, as a contribution to the discussions by EU leaders next week.
EC opens in-depth investigation into public financing of Fehmarn Belt fixed rail-road link17/06/2019 11:07:00
The EC has opened an in-depth investigation to determine whether the public financing model of the Fehmarn Belt fixed rail-road link is in line with EU State aid rules. This follows the EU General Court's annulment of a previous Commission decision approving the support.