To be able to find the right path for the introduction of a medicine in Italy, it is necessary to explore and translate the map of the regulatory environment, identifying and analysing the expectations and reports of decision-makers.
We assist those who turn to us in understanding and obtaining a fair price and reimbursement for a medicine. Finding a common ground, by appropriately mediating between Company profit, patient needs and the limited resources of the National Health Service, is a victory for all interest groups involved.
Through the years, we have learnt that the reality of things is more complex than whatever had been planned.
Even when everything is well-prepared and strategies corresponding to the value of the medicine, in accordance with the regulatory objectives of the agencies, and accommodating to drug governance guidelines, are proposed, the pathway to the authorisation of a medicine may well progress differently than expected. Not to mention any external variables that could slow down, if not hinder, the access of a medicine to the market.
Integrated skills are needed to help with navigation
Though quite detailed, the map we have provided cannot define the complexity of the terrain. Our experience comes to the aid when it is not clear.
Clarification of AIFA Administrative Sanctions The law recognises that AIFA - as the drug regulatory authority - has the power to impose administrative sanctions ...
Special European HTA Regulation The new European Regulation on Health Technology Assessment (HTA-r) 2021/2282, which comes into force on 12 January 2025, marks the ...
The National Commission for Updating the Essential Levels of Care (LEA) was renewed by Ministerial Decree of 18/03/2024. The President of the Commission ...
On 14 February 2024 in Rome, at the Capranichetta Hall of the Hotel Nazionale, the presentation of 'Basta essere Pazienti', a campaign by the ...
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