So much will change on the regulatory front next year that the UK drug regulator, the MHRA, has had to issue dozens of new guidance documents to help pharma and biotech firms navigate the new requirements and assessment routes. A key consideration is how the UK will handle centralized EU applications that are still pending on 31 December.
The UK regulatory body, the MHRA, has told pharmaceutical companies that they will have two options if they want to obtain a new “Great Britain marketing authorization” for drugs that have been filed at EU level but are still awaiting a decision when the Brexit transition period expires at the end of this year.
In new guidance issued on 1 September, companies are informed that they can choose between an MHRA assessment that is...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
