How To Get Orphan Drug Status In Great Britain From 2021
Post-Brexit Rules Broadly In Line With EU
Updated guidance from the UK regulator, the MHRA, outlines the rules on orphan drug applications, criteria and exclusivity periods that will apply in Great Britain after the end of the Brexit transition period.
You may also be interested in...
The EU Orphan Regulation and the Paediatric Regulation have helped to increase the number of products developed for rare diseases and children, but they both have some shortcomings that need to be addressed, according to an evaluation of the legislation carried out by the EU authorities. The European pharmaceutical industry has warned against opening up the legislation, saying it is “critical to maintain a stable and predictable incentives framework."
A legislative provision under which future COVID-19 vaccines can be made available in the UK before they are approved is also being used to offer an unlicensed flu vaccine that officials say has undergone full safety, efficacy and quality tests.
With product shortages made worse by the pandemic, companies in the UK are being asked to use a new system for notifying potential supply disruptions and any plans to discontinue specific medicines.