EMA Aligns Antibiotics Guideline To Help Facilitate Global Trials
The EU regulator says it supports a globally aligned approach to the development of new antimicrobial medicines.
You may also be interested in...
In the latest effort to address the growing problem of antimicrobial resistance, the EU authorities are consulting on a list of products that must not be used in animals, in order to help preserve their efficacy in humans.
Shionogi and Pfizer are now in commercial discussions after their antibiotics were recommended for use via the UK’s new subscription-style payment model, which will ensure a fixed annual fee is paid to companies regardless of how many prescriptions are issued. The UK is urging other countries to offer similar incentives to help beat global antimicrobial resistance.
With proposals for an overhaul of the EU medicines legislation due at the end of this year, EFPIA has published its formal response to the European Commission’s consultation with suggestions for facilitating new antibiotic development, testing new regulatory approaches to novel medicines, and tackling medicine shortages.