Early Access Programmes: EU Compliance Handbook

The increased market awareness for drugs targeting rare and life-threatening diseases has coincided with a rise in the number of patients requesting early access to these medicines.

To meet the demand, an increasing number of pharmaceutical and biotechnology companies are deciding to develop early access programmes. However, navigating the nuances and complexities of these programmes has proven to be a resource draining task and companies are looking to develop standards and streamline their processes.

It is imperative for companies to have a comprehensive planning strategy before the implementation of these programmes that  needs to take a number of factors into consideration. Among these, obtaining regulatory approval is of utmost importance. Understanding each country’s specific regulatory requirements poses a major challenge. Ensuring compliance to regulatory authorities is a complex and time consuming task that can greatly impact programme lead times at the detriment of the patient.