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.
The analysis addresses differences in regional access times for drug reimbursement in Italy. Following the official publication for drug reimbursement in the ...
On 12 September, the 'AIFA Incontra' initiative was held at the agency's institutional headquarters in Via del Tritone, a new way of communicating with the ...
New regulations in the legislative landscape impose a high focus on access to medicines in the near future. As of 1 January 2025, it will become operational ...
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