Marketing approval

Once all three phases of the clinical trials are complete and the results demonstrate that the new drug is both safe and effective, it can be submitted for regulatory approval to gain marketing authorisation.

Gaining permission to market a new drug in the UK is a complex and often lengthy process. Drug companies must submit an application to the MHRA, which may take into account licensing decisions made by the European Commission/EMA. The licence specifies which patient groups the treatment is for, its dosage and how it is administered (often in combination for myeloma treatments).