After completing all the necessary preclinical and clinical research, the next step is getting approval for the repurposed drug from regulatory agencies like the MHRA, FDA or EMA (see Regulation and Securing Patient Access). These agencies will review the drug’s safety, effectiveness, and quality for its new use. If it meets their standards, the drug will be approved for treating the new condition.

Once the drug is approved, managing access becomes a key focus. This means ensuring the drug is available to those who need it while also controlling its distribution for safe and proper use. This can include deciding who can prescribe the drug, how it is prescribed, and monitoring its use for any side effects or issues that arise.