The EMA recently released information on fee's payable for some pharmacovigilance requirements, meaning the industry will be contributing to the EMA's drug safety costs.
The legislation to strengthen the EU pharmacovigilance comes at a price, literally. The new legislation now means that the industry will be charged fees by EMA to recoup the costs, opposed to the previous route where cost of these activities was publicly funded.
The 2008 legislative proposal on pharmacovigilance which is being used as the building blocks for these changes shows the specific areas that will face fees. Some of the proposed fees:
- PSUR assessment for each assessment of a PSUR for products that have been authorised for 2 years or more – maximum 80,300 â‚¬
- PSUR assessment for products which have been authorised for less than 2 years – 40,150â‚¬
- Final PASS study report – 80,300 â‚¬.
- Assessment of Pharmacovigilance Referrals – ranging from 80,300â‚¬ to a maximum of 267,400â‚¬ depending on the EMA workload involved
Small & midsized enterprises
Existing legislation provides a number of incentives for SMEs. The report highlights the importance in ensuring any amendments to the current legal framework regarding the payment of fees by SMEs to EMA for pharmacovigilance does not undermine these incentives and leave SMEs forced to make unbalanced contributions.