Bridging the continents: meet Asphalion’s US Agent in May in Europe!
From the 5th to the 16th May, Bruce Thompson, our U.S. Agent, an expert on FDA regulations and procedures, will be in Europe.
Extedo has released their latest product for the XEVMPD compliance: MPDviewer.
This is a free of charge tool, which has been available from the 9th of April.
For more information contact xevmpd@asphalion.com
The European Medicines Agency has introduced new fee incentives to support micro, small and medium-sized enterprises (SMEs) developing medicines for human and veterinary use. The new incentives apply to post-authorisation activities. They include total or partial fee exemptions for the following activities:
- extension of a marketing authorisation;
- type-IA, type-IB or type-II variation;
- renewal of a marketing authorisation;
- transfer of a marketing authorisation between two SMEs;
- referral procedure initiated by the marketing-authorisation holder as laid down in Article 30(1) or the first sub-paragraph of Article 31(1) of Directive 2001/83/EC;
- post-authorisation annual fee.
Micro-sized enterprises will benefit from a 100% fee reduction, while small and medium-sized enterprises will have a 40% reduction of the total applicable fee.
FDA GDUFA Performance Report
Sonia studied Pharmacy at the University of Barcelona and holds a Master’s Degree in Pharmacovigilance and Post-Authorisation Studies from the University of Sevilla.
For more information about our Pharmacovigilance services, please contact: T +34 93 238 59 45 – qppv@asphalion.com
