The European Medicines Agency (EMA) have opened up an early dialogue, which is available through its Innovation Task Force (ITF), to all medicine developers working on therapeutic approaches for the treatment or prevention of bacterial and fungal infections.
ITF is a forum for dialogue between regulators and developers of innovative emerging therapies, methods and technologies that are in the early stages of research and development. The EMA is encouraging all developers working on medicines for the treatment or prevention of life-threatening microbial infections to take part in early dialogue with the EMA to help strengthen the drug development pipeline for new antimicrobials.
The development of new medicines to treat resistant bacterial or fungal infections is a high priority for the EMA and the European medicines regulatory network, as without sustained effort to contain antimicrobial resistance common diseases are likely to become untreatable.
The ITF, which is a free of charge service, aims to encourage early interaction and broad-ranging discussions between medicine developers and the regulatory authorities. The EMA hopes this will help medicine developers’ understanding and subsequent use of regulatory tools such as EMA’s scientific advice.
The aim of the platform for early dialogue is to prioritise and speed up the development of antimicrobial medicines. The EMA have stated that “interested medicine developers are encouraged to contact the ITF secretariat at email@example.com to discuss their development plans for medicinal products addressing bacterial and fungal infections.”
To read more about EMA’s early engagement with medicine developers to fight antimicrobial resistance, please click here.