AIFA
September 12, 2024
The AIFA Board of Directors examined and approved 38 dossiers in the session held on Wednesday 11 September 2024 for which the Scientific and Economic Commission for Medicines (CSE) completed the evaluation process
by Farmacista33 Editorial Staff
Table of Contents
The AIFA Board of Directors has examined and approved 38 dossiers for which the Scientific and Economic Commission for Medicine (CSE) has completed the evaluation process. Among the new authorized medicines, 4 orphan drugs for rare diseases and 5 drugs based on new active ingredients, in addition to 6 extensions of therapeutic indications.
Approved drugs
The orphan drugs authorised and eligible for reimbursement by the NHS are for the treatment of the following pathological conditions.
Biosimilar Pyzchiva (<a href="https://www.archyde.com/drug-causes-unusual-case-of-psoriasis-in-patient-who-developed-erythroderma/” title=”Drug causes unusual case of psoriasis in patient who developed erythroderma”>ustekinumab), a monoclonal antibody for psoriasis, was also authorised. The Board also approved the list of medicinal products authorised under a simplified procedure (generics and parallel imports).
Source:
https://www.aifa.gov.it/-/cda-aifa-approva-9-nuovi-farmaci-di-cui-tre-antitumorali
TAG: APPROVAL OF NEW DRUGS, SCIENTIFIC AND ECONOMIC COMMISSION OF DRUG (CSE) AIFA
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Italian Medicines Agency database
AIFA: Ensuring Access to Innovative and Safe Medicines in Italy
The Italian Medicines Agency (AIFA) plays a crucial role in ensuring that patients in Italy have access to innovative and safe medicines. As the national authority responsible for the regulation of medicines, AIFA is committed to evaluating and approving new drug applications, monitoring the safety of authorized medicines, and promoting transparency in the pharmaceutical industry.
Transparency Lists: Promoting Fair Pricing and Competition
AIFA publishes Transparency Lists, which provide information on medicinal products and their reference prices, including any reductions foreseen by AIFA Resolutions [[1]]. This transparency enables patients, healthcare professionals, and pharmaceutical companies to make informed decisions about treatment options and pricing. The lists also promote fair pricing and competition in the pharmaceutical market, ensuring that patients have access to affordable and effective medicines.
Generic Medicinal Products: Equivalent Alternatives
AIFA recognizes the importance of generic medicinal products, which offer equivalent alternatives to innovative medicines at a lower cost. The agency provides guidance on the authorization and use of generic medicines, ensuring that patients have access to affordable treatment options [[2]]. Generic medicines are recognizable by the words “Equivalent medicine” on the package leaflet and outer packaging, providing patients with confidence in the safety and efficacy of these products.
Innovative Medicinal Products: Classifying and Authorizing New Therapies
AIFA is committed to supporting innovation in the pharmaceutical industry, recognizing the importance of new medicines in improving patient outcomes. The agency has established criteria for the classification of innovative medicinal products, including innovative oncological medicinal products [[3]]. This enables AIFA to evaluate and approve new drug applications quickly and efficiently, ensuring that patients have access to the latest treatment options.
Recent Approvals: Expanding Treatment Options for Patients
In its latest session, the AIFA Board of Directors examined and approved 38 dossiers, including four orphan drugs for rare diseases, five drugs based on new active ingredients, and six extensions of therapeutic indications. These approvals expand treatment options for patients in Italy, providing new hope for those living with rare and debilitating diseases.
Conclusion
AIFA plays a vital role in ensuring that patients in Italy have access to innovative, safe, and affordable medicines. Through its Transparency Lists, generic medicinal products, and innovative medicinal products, AIFA promotes fair pricing, competition, and innovation in the pharmaceutical industry. The agency’s recent approvals demonstrate its commitment to expanding treatment options for patients, improving health outcomes, and enhancing the quality of life for Italians.
