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New AIFA special: CSE and reorganisation

The series of Nomos and Pharma Value specials regarding the governance of the Medicine and its Agency continues.

After the seven extensions of the AIFA Committees (CTS and CPR), it was published in the Official Journal on 15 January 2024 the Decree of the Minister of Health, in agreement with the Minister of public administration and the Minister of Economy, the new “Regulation amending the regulation on the organization and operation of the Italian Medicines Agency (AIFA) entered into force on 30 January 2024.

We are finally approaching the definition of the new structure of the Agency.

The main points of the Reform are:

  • the abolition of the General manager
  • the President, appointed by the Minister of Health, in agreement with the Regions, assumes all powers, including the legal responsibility of the Agency
  • the president is supported by new figures: the Administrative Director and the Technical-Scientific Director
  • the abolition of the Technical-Scientific Committee and the Price and Reimbursement Committee and establishment of the Scientific and Economic Committee (CSE).

In this special, compared to the previous, we have updated the scheme of appointments on the basis of the changes required by the State Regions Conference and the State Council.

Taking up what was done in Special No 1 “The AIFA Committees from 2004 to 2021”, we realized a focus on the characteristics of the members that make up this first CSE with regard to gender, profession, Region of origin.

 

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