EMA publishes report on workshop on regulatory options in the fight against antimicrobial resistance
The European Medicines Agency (EMA) today published a report highlighting the outcomes of its workshop entitled Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem, hosted at the Agency on 8 November 2013. The report gives an overview of the key issues discussed at the event, as well as recommendations, in the following three areas:
- the approval process for new antibiotics in Europe, and whether the newly-defined regulatory requirements are considered adequate for fostering rapid development of new antibacterial agents;
- encouraging appropriate use of antibacterials as one of the tools to reduce the speed at which antimicrobial resistance develops;
- aspects related to research and development, including agreement on the importance of efficient and early dialogue between industry and the EMA to facilitate medicine development.
The Agency has also published a video recording of the workshop and the slides presented by the speakers.
The event, which was organised in collaboration with the European Commission, brought together key EU and international stakeholders. The objective of the workshop was to facilitate discussion around the optimal ways in which existing EU legislation with regard to medicinal products could be better used to foster the development and approval of new antibiotics and to address the growing challenge of antimicrobial resistance.
More information on the workshop, including the presentation slides and video recording, is available on the event page.
- Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem (08/11/2013)
- European Medicines Agency to host workshop on regulatory options in the fight against antimicrobial resistance (26/09/2013)
- Antimicrobial resistance
- Antimicrobial resistance: regulatory information