European Industry Proposes Incentive To Develop New Antimicrobials
EFPIA Urges Care Over Definition Of ‘Unmet Medical Need’
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.
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A European public health NGO has disputed the suggestion that a transferable exclusivity extension is the answer to the lack of innovative antimicrobial drugs in company pipelines.
The EU regulator says it supports a globally aligned approach to the development of new antimicrobial medicines.
Coronavirus Notebook: Richer Countries Urged To Pay ‘Fair Share’ Of Vaccine & Drug Financing, EU Assesses Comirnaty Boosters
EFPIA has welcomed an evidence-based report on the regulatory flexibilities used in Europe during the pandemic and how they could be further employed in future. The EMA’s drug safety committee is looking at more reports of menstrual disorders with mRNA vaccines.