MHRA-NICE aligned pathway
The MHRA-NICE aligned pathway opens on 1st April 2026. The pathway and an improved advice service will help get new medicines to patients faster and support companies to plan with more certainty.
The MHRA-NICE aligned pathway opens on 1st April 2026. The pathway and an improved advice service will help get new medicines to patients faster and support companies to plan with more certainty.
The countdown to the new regulations for clinical trials has begun. The regulations come into effect on 28th April 2026.
In the world of pharmaceutical distribution, product recalls aren’t an occasional inconvenience—they’re an operational reality. And when they occur, the expectations on wholesale dealers are high. The MHRA’s guidance is clear: distributors sit at a pivotal junction in the recall process, and their preparedness can determine whether a quality issue stays contained or becomes a national problem.
When quality issues arise in the lifecycle of a medicinal product, the consequences extend far beyond the pharmacy shelf. The MHRA’s latest 2026 guidance on defective medicinal products offers a comprehensive roadmap for managing these events with rigour, transparency, and patient safety at the centre.
There is a hard stop to the change process, from 1st April the system will be operable, and the products registered at that point will decide the fees payable for 2026/27. So, there are a number of actions manufacturers and UKRPs will need to consider.
To place medical devices onto the UK market manufacturers must register with the MHRA and register all relevant products, registration must be active when each batch of product is placed on the market. For manufacturers based outside the Uk this is done via the UKRP.