Our focus is on enrolling patients in clinical trials to obtain the data required to enable regulatory and reimbursement authorities to review and decide on whether these new medicines should be marketed and reimbursed. Approval by regulatory authorities is the only way to make medicines broadly available to patients for use under the supervision of a qualified healthcare professional or doctor.
However, we recognise that some patients with serious or immediately life-threatening diseases may not be eligible for any clinical trials and may not have other options. Hence, under specific circumstances and in compliance with applicable laws, Roche may provide patients with pre-approval access (PAA) to unapproved or investigational medicines outside the clinical trials process, before they are approved by regulatory authorities. This could be through an Expanded Access Program, a Pre-Approval Safety Study or through Compassionate Use.
