On The Rise In The EU: New Drug Applications, Conditional Approval Recommendations
Applications to the European Medicines Agency are continuing to rise, with orphan drugs playing a part in the increase, but the numbers of drugs for new pediatric indications and those for use outside the EU are still lamentably low. For the first time in five years, the CHMP issued no negative opinions, but more applications for accelerated assessment were rejected than accepted.
You may also be interested in...
Smaller biopharmaceutical firms are increasingly making use of the EU’s centralized approvals procedure and the EMA’s scientific advice and other support services, and are also proving to be keen users of the agency’s priority medicines scheme (PRIME), accounting for half of all PRIME applications in 2016.
The number of conditional marketing authorizations granted in the EU reached an all-time high in 2016, with eight products approved under the early access pathway. In 2017, so far, a CMA has been granted for Roche’s product Alecensa, and Shire’s Natpar has been recommended for approval under the pathway. In addition, a European Commission expert group that has been exploring how to improve the CMA process and eliminate the negative perceptions surrounding its use is examining a key report on how the pathway is faring.
In 2016, oncology drugs again topped the list of medicines for which the European Medicines Agency recommended a centralized marketing authorization.