Early Access Programs

Early Access Programs (EAPs) or Expanded Access Programs (EAP)  allow patients (individuals or group of patients) to access unregistered life-saving medicines undergoing clinical trials or awaiting market authorization.. EAPs are commonly considered as an alternative to open-label extension clinical trial because it provides opportunity to evaluate outcomes in a real-world setting outside of clinical trials, and gain an insight into potential value of the drug.

Sponsors may retain physicians within EAP not only by obtaining valuable early experience with a product, but also in having official payments and reimbursment of thrie involvment. In addition to that  pharmaceutical companies have good launch preparedness, with the optimal operational processes such as supply chain established, and price guidelines are set for future reference, which may help to facilitate the launch pricing and reimbursement negotiations in the future.

Health Logistics is assisting in getting through the complex regulatory process in a structured straightforward way by guiding you the the process:

Not all of the countries have programs to allow cohorts of patients rather than individuals, to benefit from early access. Reach out to us for regulatory overview.