EMA Moves To Ensure ‘Smooth’ Evaluation Of Drug Approval Dossiers
Complex Cases May Still Require Tailored Meeting
Drug sponsors seeking centralized EU marketing authorizations now have the opportunity to have simpler pre-submission “interactions” with the European Medicines Agency six months before the submission to help avoid complications down the line. Full meetings may still be appropriate for complex issues such as requests for accelerated assessment or conditional approval.
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The small central African country has been chosen to host the planned African Medicines Agency and is also set to be a key player in medicines and vaccines manufacturing technology on the continent.
Coronavirus Notebook: EMA Issues New COVID-19 Vaccine Safety Updates, Australia Assesses Comirnaty In Younger Children
The European regulator has warned of the risk of myocarditis, pericarditis and anaphylaxis with Novavax’s COVID-19 vaccine, Nuvaxovid, while Switzerland has updated its guidance on the use of COVID-19 medicines against virus variants. Iconovo has received funding to develop its ICOone nasal inhaler for use in pandemics in resource-poor settings.
Protection of IP and trade secrets and the need for clarity around issues such as the rules on access to data and the sharing of clinical trial data are seen as key issues in the European Commission’s plans for a European Health Data Space.