Who is in charge of granting the designation orphan designation to a medicine?
The European Medicines Agency (EMA) is responsible for the designation of orphan medicinal products.
Who is responsible for the authorisation and supervision of a clinical trial?
The authorisation and supervision of a clinical trial is the responsibility of the country where the trial is conducted. In Spain, this is the Agencia Española de Medicamentos y Productos Sanitarios(AEMPS), a state agency attached to the Ministry of Health.
Where are pricing and reimbursement decisions for orphan drugs made?
Once a medicine obtains marketing authorisation from the European Commission, decisions on price and reimbursement are taken in each country. In Spain, they are decided by the Interministerial Commission on Medicines Prices (CIMP), which is attached to the General Secretariat of Health and Consumer Affairs, as the collegiate body responsible for setting the maximum industrial price.