The MHRA says that further guidance is coming on the dossier requirements and fee levels for the new recognition procedure, and that electronic forms for determining the eligibility of submissions for the procedure will be published shortly.
The UK’s new International Recognition Procedure is intended to “enhance the attractiveness of the UK” by creating an environment where the pharmaceutical sector is able to develop and launch new medicines more quickly for the benefit of public health, according to Julian Beach of the Medicines and Healthcare products Regulatory Agency (MHRA).
At the beginning of 2024, the IRP will replace the European Commission Decision Reliance Procedure (ECDRP), which allows the MHRA...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
