Latest from Anabel Costa-Ferreira
Regulators in the US and Canada are working together to streamline approval timelines for generic drugs through a voluntary information sharing program.
Deputy chief Jonathan Benger moves up to become NICE’s fourth-ever CEO. While the face may be familiar, the challenges are anything but as the HTA body has launched a new joint scientific advice process with the MHRA and will implement new cost-effectiveness thresholds driven by a US trade deal.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
The UK medicines regulator, the MHRA, and England’s health technology appraisal (HTA) body, NICE, spoke to the Pink Sheet about the new pathway that aligns the HTA and regulatory processes to cut the time it takes to bring medicines to market.
The UK’s medicines regulator reports promising outcomes from a pilot scheme testing streamlined processes for reviewing low-risk substantial modifications to ongoing clinical trials.
The European Commission says it will soon publish an updated study on the impact of the Urban Waste Water Treatment Directive on the pharmaceutical and cosmetics industry and that it would support member states in avoiding “unintended consequences.”
