New WHO prequalification charges could scare off generics companies
This article was originally published in Scrip
Executive Summary
New application fees of up to $8,000 could discourage generics manufacturers from submitting their products for prequalification by the World Health Organization, non-governmental organizations have warned. The WHO decided to introduce fees amid concerns over the viability of its current funding model.
You may also be interested in...
Germany Confirms No Reimbursement Status For ‘Lifestyle’ Drug Wegovy
In Germany Novo Nordisk’s obesity drug Wegovy will remain excluded from reimbursement for obesity, unlike Rhythm’s Imcivree.
New HTA Evidence Guidelines In EU Could Spell Trouble For Advanced Therapy Companies
New guidelines that cast doubt over use of single-arm and non-randomized studies are “discouraging” for rare disease patients and the advanced therapy sector, says ARM, the Alliance for Regenerative Medicines.
Germany Courts Clinical Trials With Regulator Reshuffle & New Federal Ethics Committee
Plans to rejig two regulators’ roles and streamline the ethics committee system have drawn some criticism.