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 registered 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.
However, Roche recognizes that some patients with serious or life-threatening diseases or conditions may not be eligible for any clinical trials and may not have other treatment options available. Hence, under specific circumstances and in compliance with applicable laws and regulations, Roche may provide patients with Pre-Approval Access (PAA) to investigational medicines outside the clinical trials process, before they are approved by regulatory authorities. This could be for a group of patients through local PAA Programs such as an Expanded Access Program or for individual patients through Compassionate Use.
Further information on PAA can be found in our
The following global compassionate use programs are currently available *:
(*open for requests by qualified healthcare professionals)
DISCLAIMER: An existing program does not guarantee availability in all countries. Various regulatory mechanisms exist in different countries to provide PAA to new medicines and as a result, country specific variations for PAA will occur. Any pre-approval access to medicines must always comply with the applicable country-specific laws and regulations, including medicine importation requirements (see below some examples**).
For further information about these Programs in your country please contact the medical information team in your country or submit your question using the
** Examples of country specific regulations
France: All cohort ATU programs are published on the website of the French Health Authority:
This website contains information on products which is targeted to a wide range of audiences and could contain product details or information otherwise not accessible or valid in your country. Please be aware that we do not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin.