EMA prepares for 2011
Looking to 2011, the European Medicines Agency (EMA) has adopted its work program and budget for the year, as well as a new Road Map to 2015.
Looking to 2011, the European Medicines Agency (EMA) has adopted its work program and budget for the year, as well as a new Road Map to 2015. The agency expects a similar number of marketing authorizations this year compared with last, with 43% of those attributable to generics and 41% to new medicines.
According to press statement, the work program forecasts a stable number of applications for marketing authorizations for human medicines in 2011, with 97 applications expected in total, compared with 95 in 2010. Of these, 40 are expected to be for new medicines, 12 for orphan medicines and 42 for generic applications. The budget for 2011 is 208.9 million Euros, representing an increase of 0.23% compared with 2010, and includes fee revenue of 161 million Euros and an EU contribution of 33.5 million Euros, down from 39.1 Euros in 2010. The special orphan medicines fund given by the EU has also been slashed from 8.2 million Euros to 4.9 million Euros.
The EMA’s management board has also adopted its new Road Map to 2015, which builds on the success of the first road map for 2005 to 2010. The final road map, due to be published later this month, focuses on delivery of the EMA’s core business, as well as three priority areas for future actions to strengthen the EMA’s role in addressing public health needs, facilitating access to medicines an optimizing safe use of medicines. The adoption follows public consultation from the first half of 2010 and takes into account responses from more than 70 stakeholders.
The EMA will face 2011 without Thomas Lönngren, who ended his 10-year mandate as Executive Director of the EMA on 31 December 2010.
Navigating Annex 1 for Early Phase Sterile Fill Finish in Clinical Supplies
November 21st 2024Stay compliant with Annex 1 for early phase sterile fill finish processes. Discover how to implement robust contamination control strategies, integrate isolator technology, and conduct integrity testing to meet stringent European Union standards. The guide provides a comprehensive look at key elements such as PUPSIT, critical zone controls, and monitoring and training for aseptic processes.
Why is the PDA Pharmaceutical Microbiology Conference the Hottest Ticket in the Industry?
October 10th 2024Get a glimpse of the power and popularity behind the PDA Pharmaceutical Microbiology Conference from two planning committee members, Julia Marre, PhD (Associate Director, Scientific and Regulatory Affairs at Pocket Naloxone Corp) and Dawn Watson (Executive Director, Global Micro Quality and Sterility Assurance at Merck). This candid conversation reveals why this industry event is so influential…and always sold out! The speakers discuss what makes the PDA Pharmaceutical Microbiology Conference so vital to industry professionals, as well as how to become a part of this dynamic professional community.
Ensuring Quality from the Start: Raw Materials Testing Support
November 21st 2024Raw Materials are the foundation of every biopharma product. Our ultimate guide highlights how our testing support can help you establish purity, identity, and quality standards, ensuring a smooth manufacturing process and adherence to regulatory requirements.
Ensure the Safety of Allogeneic Therapies with Advanced qPCR Testing
November 21st 2024Elevate your viral screening with Eurofins BioPharma Product Testing’s qPCR- based assays. Our advanced testing goes beyond standard screenings to detect even dormant and hard-to-detect pathogens, ensuring comprehensive safety in every stage of the allogeneic therapy pipeline. Protect your products – and your patients- with industry-leading sensitivity and specificity.
