UK-based qualified persons responsible for pharmacovigilance face an uncertain future following Brexit, as the law requires them to “operate and reside” in the EU. They are calling for an appropriate transition period until industry makes alternate arrangements.
There is a high level of anxiety among UK-based qualified persons responsible for pharmacovigilance (QPPVs) as it appears that their fate in the post-Brexit scenario will likely be decided by the marketing authorization holders who appointed them in the first place to fulfil various obligations specified in the EU pharmacovigilance legislation.
The pre-condition in the EU legislation that QPPVs “shall operate and reside in the Union” has become the primary cause...
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The European Medicines Agency’s safety committee has concluded that the benefits of medicines containing metamizole continue to outweigh the risks but that new measures are needed to minimize the serious outcomes of agranulocytosis.
Finding the right way to measure outcomes is just one of the difficulties involved in conducting clinical trials of potential new therapies for loss of hearing, which can have a number of different causes.
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
