EU industry still unhappy over PV fee burden as legislation nears approval
This article was originally published in Scrip
Executive Summary
European industry bodies have generally welcomed last week's compromise deal on the new fees for pharmacovigilance activities, but are disappointed that the fee level for safety referrals is significantly higher than originally proposed by the European Commission. They are also concerned that industry is being asked to share the whole burden of funding the EU's new pharmacovigilance activities.
You may also be interested in...
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.
Denmark Planning To Impose Drug Stockpiling Obligations From July
A new bill is intended to address the increase in medicine supply problems in Denmark in recent years.
National Drug Stockpiles Create ‘False Sense Of Security’
The generics and biosimilars industry body Medicines for Europe says disparate national stockpiling requirements are not a solution to shortages and can bring “significant risks” for the supply chain and access to medicines.