SMEs Making The Most Of EU Centralized Procedure And Scientific Support From EMA
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.
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A new action plan from the European Medicines Agency is intended to promote innovation in SMEs by raising awareness of the regulatory tools and support available from the agency, offering more training and education, and promoting collaboration among SMEs, academia, and other stakeholders.
Three out of four applications have been denied entry to the European Medicines Agency’s priority medicines (PRIME) scheme for getting drugs for unmet medical needs to patients faster. Robert Hemmings, who chairs the EMA’s scientific advice working party, explains why.
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.