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.
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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."
The Russian backers of the vaccine’s development say that if it receives a marketing authorization in the EU, distribution could begin in June this year.
Coronavirus Notebook: EU Moots Emergency Use Authorization Scheme For Vaccines, Janssen Product Up For 11 March Approval
Celltrion’s regdanvimab is undergoing an emergency use procedure in Europe, the European Medicines Agency and the health authorities in Canada have jointly published clinical data on the Moderna vaccine, and Canada has approved two versions of the AstraZeneca/Oxford University jab.