From the beginning of 2021, companies wanting an orphan drug designation in Great Britain will need to apply for it at the same time as they file the marketing authorization application (MAA), using a new application form. There will be "no pre-marketing authorization orphan designation” for Great Britain, says new guidance on post-Brexit medicines regulation.
Incentives for orphan drug development will be provided in the form of market exclusivity and “full or partial refunds for marketing authorization fees,” and waivers from scientific advice fees will...
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