Digest del 02/09/2026 – Osservatorio Regolatorio Pharma

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Pubblicazioni dal 01/09/2026 06:25 a ora — 38 news

AIFA (2)

Ricognizione medicinali relativamente a officina farmaceutica: Lianyungang Guike Pharmaceutical Co. Ltd. Cina

Richiesta alle Aziende Farmaceutiche detentrici dell’Autorizzazione all’Immissione in Commercio di medicinali ad uso umano prodotti per il mercato italiano e/o per l’esportazione contenenti sostanze attive e/o intermedi prodotti presso l’officina farmaceutica Lianyungang Guike Pharmaceutical Co. Ltd.

Tabelle farmaci di classe A e H al 30/04/2026

AIFA rende disponibili per tutti gli Operatori sanitari le tabelle contenenti l’elenco dei farmaci di fascia A e H, dispensati dal Servizio sanitario Nazionale, ordinati rispettivamente per principio attivo e per nome commerciale.

Gazzetta Ufficiale – Serie Generale (1)

AGENZIA ITALIANA DEL FARMACO - COMUNICATO

Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano, a base di desamfetamina solfato, «Amfexa». (26A04316)

TrovaNorme – Newsletter AIFA (1)

MONITORAGGIO CONFEZIONI MEDICINALI - ISTITUZIONE BANCA DATI

Pubblicato il 14/08/2026

EMA – News & press releases (1)

Voluntary data submission pilot to advance innovative alternatives to animal testing

EMA has launched a new voluntary data submission (VDS) pilot to facilitate the sharing of data generated using New Approach Methodologies (NAMs). These innovative methods have…

EMA – Regulatory & procedural guidelines (1)

IRIS guide for applicants - How to create, submit and manage IRIS applications, for industry and individual applicants

EMA – What's new (22)

Highlight report from the 16th industry stakeholder platform on research and development support

Scientific advice for high-risk medical devices

Regulatory Procedure Management (RPM) for the Product Lifecycle Management (PLM) in IRIS - Frequently asked questions

20th anniversary of European Medicines Agency's Patients' and Consumers' Working Party (PCWP), Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 June 2026, 13:30 (CEST) to 30 June 2026, 17:30 (CEST)

Organisation chart: Task Forces

Organisation chart: Veterinary Medicines

ACT EU multi-stakeholder platform annual meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, 22 October 2026

Regulatory acceptance of new approach methodologies (NAMs) to reduce animal use testing

New approach methodologies to replace and reduce animal testing: Voluntary data submission pilot

Voluntary data submission (VDS) pilot application form

Human medicines European public assessment report (EPAR): Aujemflu, Influenza vaccine (surface antigen, inactivated, adjuvanted, prepared in cell culture), Date of authorisation: 20/08/2026, Status: Authorised

Human medicines European public assessment report (EPAR): Zadenvi, denosumab, Date of authorisation: 26/06/2025, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Seffalair Spiromax, salmeterol,fluticasone propionate, Date of authorisation: 26/03/2021, Revision: 4, Status: Authorised

COVID-19 medicines

Human medicines European public assessment report (EPAR): Ngenla, somatrogon, Date of authorisation: 14/02/2022, Revision: 10, Status: Authorised

Portfolio and technology meetings

Product Management Service (PMS) public API beta release - Technical overview and live demo, Online, from 13 July 2026, 14:00 (CEST) to 13 July 2026, 15:30 (CEST)

Human medicines European public assessment report (EPAR): Kymriah, tisagenlecleucel, Date of authorisation: 23/08/2018, Revision: 24, Status: Authorised

Managing product data quality in PMS: processes, known issues, current status and best practices, Online, from 21 July 2026, 14:00 (CEST) to 21 July 2026, 15:30 (CEST)

Human medicines European public assessment report (EPAR): Myqorzo, aficamten, Date of authorisation: 12/02/2026, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Omvoh, mirikizumab, Date of authorisation: 26/05/2023, Revision: 9, Status: Authorised

EU Union Register of Medicinal Products (10)

EU/3/24/2911 (Les Laboratoires Servier)

EU/3/24/2911 (Active substance: Sevasemten) - Transfer of orphan designation - Commission Decision (2026) 6166 of Fri, 28 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/OD/0000362196

EU/3/24/2907 (Les Laboratoires Servier)

EU/3/24/2907 (Active substance: Sevasemten) - Transfer of orphan designation - Commission Decision (2026) 6167 of Fri, 28 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/OD/0000362190

EU/3/16/1715 (MeiraGTx Belgium)

EU/3/16/1715 (Active substance: Adenovirus associated viral vector serotype 5 containing the human RPGR gene) - Transfer of orphan designation - Commission Decision (2026) 6164 of Fri, 28 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/OD/0000368680

Orladeyo (Biocryst Ireland Limited)

Orladeyo (Active substance: berotralstat) - Centralised - Variation - Commission Decision (2026) 6127 of Thu, 27 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/X/0000268892

Jylamvo (Oresund Pharma ApS)

Jylamvo (Active substance: methotrexate) - PSUSA - Modification - Commission Decision (2026) 6121 of Thu, 27 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/PSUR/0000327873

Rezolsta (Janssen-Cilag International NV)

Rezolsta (Active substance: Darunavir/Cobicistat) - Centralised - Variation - Commission Decision (2026) 6126 of Thu, 27 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/X/0000268372

Saphnelo (AstraZeneca AB)

Saphnelo (Active substance: anifrolumab) - Centralised - Renewal - Commission Decision (2026) 6122 of Thu, 27 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/R/0000335943

Jivi (Bayer AG)

Jivi (Active substance: damoctocog alfa pegol) - Centralised - 2-Monthly update - Commission Decision (2026) 6020 of Fri, 21 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/VR/0000326847

EU/3/24/2914 (Essential Pharma Limited)

EU/3/24/2914 (Active substance: Humanised IgG1 (K322A) monoclonal antibody against disialoganglioside GD2) - Transfer of orphan designation - Commission Decision (2026) 5990 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/OD/0000361773

Ranivisio (Midas Pharma GmbH)

Ranivisio (Active substance: ranibizumab) - PSUSA - Modification - Commission Decision (2026) 5968 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/PSUR/0000327906

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