FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

UK Trade Groups Question MHRA’s ‘No-Deal’ Brexit Plan

Nov. 19, 2018

Two prominent UK drug organizations say they’re “generally supportive” of MHRA’s contingency plans if the UK exits the EU on March 29 without a deal, but they expressed concern about orphan drugs and centrally authorized product licenses, among other issues.

The MHRA proposes modifying the EU’s orphan drug requirements to create UK-specific criteria related to the prevalence of the rare disease, the availability of satisfactory treatments and significant benefit to the country.

The agency is also considering keeping the “most important orphan incentive” — the 10-year market exclusivity that shields orphan drugs from competing with similar products — and assessing the orphan designation only at the marketing authorization stage to encourage applications for rare disease treatments.

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