Italy’s Medicines Regulatory Body Undergoes Major Reorganization
A major reorganization of the Italian Medicines Agency (AIFA) is set to take full effect on January 30th, following the publication of a ministerial decree earlier this month. The reorganization aims to make AIFA more streamlined and efficient, and will involve the appointments of new bodies and leaders, as well as internal restructuring.
The decree, which contains amendments to the regulation on the organization and functioning of AIFA, abolishes the figure of general manager and maintains the president as the body and legal representative of the Agency. It also establishes the general management figures of the managing director and the technical-scientific director.
Additionally, the decree provides for the suppression of the technical-scientific consultative commission and the prices and reimbursement committee, which are currently operating at AIFA. These bodies will be replaced by the Scientific and economic drug commission, to which the relevant functions will be attributed.
The reorganization also includes changes to the composition of the board of directors, which will now be made up of the president and four members designated by various entities, including the Minister of Health and the Minister of Economy and Finance.
The decree outlines the process for appointing the president, managing director, and technical-scientific director, as well as the members of the Scientific and economic drug commission. It also imposes a ban on the president from carrying out other public and private professional activities.
The new appointments and internal restructuring are expected to bring about a more efficient and effective regulatory body for medicines in Italy. The changes will come into effect on January 30th, marking a significant milestone for the future of AIFA.
The reorganization of AIFA is a key development in Italy’s efforts to ensure the safety and efficacy of medicines in the country. It represents a commitment to upholding high standards in the regulation of pharmaceutical products and is expected to have a positive impact on the healthcare system as a whole.