Companies wanting to use the new accelerated procedure will be paying more than £68,000 for the privilege, and will have to inform the UK medicines agency of any divergent decisions by reference regulators.
From 1 January, pharmaceutical companies seeking a marketing authorization from the UK regulator, the MHRA, can use the new International Recognition Procedure (IRP), under which the MHRA will be able to take account of approval decisions taken by seven other world regulators.
The IRP, which is intended to accelerate assessments at the MHRA, offers two routes to approval, Recognition A and Recognition...
Perrigo aims its new SolpaOne high-strength paracetamol effervescent at UK pharmacists, who now have expanded powers as part of the UK government's Pharmacy First initiative.
Germany's Alzchem failed to convince the UK's health claims committee that daily creatine supplementation can contribute to improved cognitive function.
A round-up of the latest moves in Europe's consumer health industry: Galenica names head of new Products & Home Care business unit; Haleon appoints general counsel; Alliance Pharma eliminates COO role.
Consumer health, particularly food supplements that make unauthorized medical or health claims, has been a key area of focus for the UK Advertising Standards Authority's recently introduced Active Ad Monitoring system, which captures ads by relevant advertisers from a range of social media platforms, and applies machine learning algorithms to identify and flag likely non-compliant ads, which are then sent to experts to review and act on. This infographic highlights recent ASA rulings against ads for supplements claiming to treat anxiety and stress, menopause, autism/ADHD and weight loss, which were flagged by AI.
OTC erectile dysfunction treatment Eroxon has made it to the Nordics through local distributor Navamedic, which has reported strong consumer uptake.
A round-up of the latest global health and wellness moves: Nestlé and Dr Reddy's name JV head; Be-sup hires comms and regulatory director; Ascendis Health appoints interim CFO.
David Ball moves from Bayer’s North America business to be Perrigo’s first chief brand and digital officer. He joins CEO who also moved to Perrigo from Bayer with decades of branded product experience.
