SafetyDrugs - Pharmacovigilance Solutions

01/04/2026

Today is the deadline.
From 1 April 2026, ICSR submissions to the FDA must be in the ICH E2B(R3) format.

For pharmacovigilance teams, having a compliant safety database is now essential to ensure data consistency and avoid submission errors or delays.

Within the SafetyDrugs safety database, the FDA Submission module is designed to manage this transition seamlessly.
It enables:
• native generation of ICSRs in the E2B(R3) standard
• integration with the FDA Electronic Submissions Gateway (ESG)
• management of technical acknowledgements and validation errors

Contact us to activate it in your system or find out more in the full article

The electronic submission of Individual Case Safety Reports (ICSRs) to the FDA is moving toward the full adoption of the ICH E2B(R3) standard: from 1 April 2026, pharmacovigilance cases must be submitted exclusively in the new format. In this article, we analyze what changes in ICSR submission to FD...

26/03/2026

The FDA has launched AEMS, a new platform for collecting and analyzing adverse event data from drugs and other regulated products.
Most companies think nothing has changed: no new submission requirements, no new processes to implement.
Everything looks the same. It isn’t.

Read the full article. Link in the comments.

**

La FDA ha lanciato AEMS, una nuova piattaforma per la raccolta e l'analisi dei dati relativi agli eventi avversi derivanti da farmaci e altri prodotti regolamentati.
La maggior parte delle aziende pensa che non sia cambiato nulla: nessun nuovo requisito di presentazione, nessun nuovo processo da implementare.
Sembra tutto uguale, ma non lo è.

Leggi l'articolo completo. Link nei commenti.

24/03/2026

FDA ICSR submissions are entering a new phase: from 1 April 2026, they must be submitted in the ICH E2B(R3) format.

For many pharmacovigilance teams working with EudraVigilance, the format itself is already familiar. But submitting ICSRs to the FDA Electronic Submissions Gateway (ESG) involves different submission infrastructures, business rules and system configurations.

What does this mean in practice for pharmacovigilance operations?
In our latest article we explore:
• what changes with ICH E2B(R3) submissions to FDA
• the key differences between EMA and FDA ICSR submission workflows
• what pharmacovigilance teams should verify before the deadline

Links to the full article in English and Italian are in the first comment.

27/01/2026

The proposed amendment to the MDR introduces targeted measures that have a direct impact on vigilance and post-market surveillance.

In this article, we analyse what changes at an operational level:
– PMS as an increasingly structured decision-making process
– new approaches to PSUR and PMCF
– recalibration of incident reporting timelines
– integration of cybersecurity and trend reporting
– concrete implications for manufacturers and service providers

A technical insight for professionals who work every day on medical device safety.
👉 https://safetydrugs.it/en/proposed-mdr-amendment-vigilance-and-post-market-surveillance/

In December 2025, the European Commission presented a proposal to amend Regulation (EU) 2017/745 (Medical Device Regulation, MDR) and, in parallel, Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation, IVDR), with the aim of addressing a number of critical issues that have emerge...

13/01/2026

The new edition of SD Collection, SafetyDrugs’ annual magazine, is now available on our website. It focuses on the key topics that have shaped pharmacovigilance over the past year.

In this issue, we cover:
- EMA and GVP updates: Addendum II to GVP Module VI, HTTP schema decommissioning, and impacts on ICSR submission
- Risk management and risk communication: new perspectives on RMMs (GVP XVI – Revision 3)
- MedDRA: its essential role in pharmacovigilance and updates from versions 28.0 and 28.1
- Major industry events: AFI Symposium 2025 and the European Pharmacovigilance Congress 2025
- Pharmacovigilance and data security: the value of ISO 27001 certification
- Our commitment to social responsibility through local initiatives

An issue designed for pharmaceutical companies and service providers looking for regulatory insight, process quality, and a forward-looking approach to pharmacovigilance.

👉 Read the new SD Collection on our website (link in the first comment)

13/01/2026

È online la nuova edizione di SD Collection, il magazine annuale di SafetyDrugs dedicato ai principali temi che hanno segnato la farmacovigilanza nell’ultimo anno.

In questo numero approfondiamo:
- Aggiornamenti EMA e GVP: Addendum II al Modulo VI, disabilitazione dello schema HTTP e impatti sulla sottomissione degli ICSR
- Gestione e comunicazione del rischio: nuove prospettive sulle RMM (GVP XVI – Revision 3)
- MedDRA: ruolo chiave in farmacovigilanza e novità delle versioni 28.0 e 28.1
- I principali eventi di settore: Simposio AFI 2025 ed European Pharmacovigilance Congress 2025
- Farmacovigilanza e sicurezza dei dati: il valore della certificazione ISO 27001
- Il nostro impegno nel sociale, a supporto di iniziative sul territorio

Un numero pensato per aziende farmaceutiche e service provider che cercano aggiornamento normativo, qualità dei processi e visione tecnologica.

👉 Leggi SD Collection sul nostro sito (link nel primo commento)

25/12/2025

The SafetyDrugs team wishes you a Merry Christmas and a Happy New Year🎄

25/12/2025

Il team di SafetyDrugs ti augura buon Natale e felice anno nuovo🎄

22/12/2025

“EudraVigilance: disabling HTTP schemas”
This is the subject of the recent EMA communication.

The change concerns the disabling of HTTP references to EudraVigilance XML schemas and affects the way ICSRs are submitted via Gateway and EVWEB, with different timelines.

In our latest article, we summarise what changes from a technical perspective, the timelines defined by EMA, and the operational implications for pharmaceutical companies, with particular attention to submission flow continuity and regulatory compliance.

Further details are available here:

The European Medicines Agency (EMA) has announced the initiative “EudraVigilance disabling HTTP schemas”, introducing changes to the technical references used for the submission of Individual Case Safety Reports (ICSRs) via Gateway and EVWEB. This is a technical update aimed at strengthening the...

19/12/2025

“EudraVigilance: disabling HTTP schemas”

È l’oggetto delle recenti comunicazioni EMA.

Il cambiamento riguarda la disabilitazione dei riferimenti HTTP agli schemi XML di EudraVigilance e ha un impatto sulle modalità di sottomissione degli ICSR tramite Gateway ed EVWEB, con tempistiche differenti.

Nel nostro ultimo articolo riepiloghiamo cosa cambia dal punto di vista tecnico, le scadenze previste da EMA e le implicazioni operative per le aziende farmaceutiche, con particolare attenzione alla continuità dei flussi di sottomissione e alla compliance regolatoria.

Approfondimento disponibile qui:

EMA (Agenzia Europea dei Medicinali) ha annunciato la disabilitazione dello schema HTTP per la sottomissione degli ICSR tramite Gateway ed EVWEB. Si tratta di un adeguamento finalizzato a rafforzare la sicurezza delle trasmissioni e circoscritto alle modalità di sottomissione dei casi verso EudraVi...

18/11/2025

The European Pharmacovigilance Congress 2025 kicks off tomorrow, bringing together international experts in the field with a packed agenda. We'll be there again this year to listen, discuss, and demonstrate how SafetyDrugs can simplify the daily work of managing drug safety.

Learn more 👉 https://safetydrugs.it/en/european-pharmacovigilance-congress-2025/

The European Pharmacovigilance Congress is back, one of the key international events dedicated to drug safety surveillance. Here’s why we’ve chosen to take part again this year. European Pharmacovigilance Congress 2025: the context Scheduled from 19 to 28 November 2025, the European Pharmacovigi...

18/11/2025

Domani prende il via l’European Pharmacovigilance Congress 2025, un appuntamento che riunisce gli esperti internazionali del settore, con un agenda ricca di contenuti. Noi ci saremo anche quest'anno, per ascoltare, confrontarci e far vedere da vicino come SafetyDrugs può semplificare il lavoro quotidiano nella gestione della sicurezza dei farmaci.

Per saperne di più 👉 https://safetydrugs.it/european-pharmacovigilance-congress-2025-2/

Torna l’European Pharmacovigilance Congress, uno dei principali appuntamenti dedicati alla sorveglianza sulla sicurezza dei farmaci. Ecco perché abbiamo scelto di esserci anche quest’anno. European Pharmacovigilance Congress 2025: il contesto In programma dal 19 al 28 novembre, l’European Pha...