GNL 39: Changes to data exclusivity

The highly regulated nature of the pharmaceutical sector makes compliance a significant cost, particularly when generating the clinical and non-clinical data needed to support a marketing authorisation (MA). How can the investment in collecting this data be protected, and pharma encouraged to get their drugs on the market? The regulator’s answer is to offer data exclusivity and market exclusivity rights against generic rivals. Now the UK has left the regulatory regimes of the EU, this note examines how these important rights have been affected in the UK.

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