FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Updates Brexit Guidance With Info for Generics Manufacturers

Dec. 12, 2017

The European Medicines Agency and the European Commission broadened their guidance on Brexit to include new information for manufacturers of orphan drugs, generics and biosimilars, as well as hybrid medicines that rely on reference product data as well as new clinical trial findings.

For example, when making calculations for orphan designations, sponsors will no longer need to account for UK patients in the disease’s prevalence, such as requirements that the disease not affect more than 5 in 10,000 people in the European Union.

The new guidance updates a question-and-answer document first published in May on how the UK’s March 2019 withdrawal from the EU will affect marketing applications and authorizations, covering both human and veterinary medicines.

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