SafetyDrugs news: database and its implementation
MedDRA 29.0: what changes for pharmacovigilance
MedDRA 29.0 introduces complex changes, updates to existing SMQs and updates for pharmacovigilance data management. Here is what changes.
MIR 7.3.1: mandatory new format for medical device vigilance reporting
Starting May 1, 2026, MIR 7.3.1 is the new mandatory format for reporting incidents related to medical devices. The update impacts reporting systems and requires generating reports according to the new specifications.
ICSR Submission to FDA: ICH E2B(R3) becomes mandatory from 1 April 2026
From 1 April 2026, ICSR submissions to the FDA must be sent in ICH E2B(R3) format. Learn what changes for pharmacovigilance systems and FDA ESG submissions.
Personal data in ICSRs: compliance is a matter of system architecture
Managing personal data in ICSRs requires structured control of regulatory data flows. GDPR and GVP Module VI Addendum II make masking and data minimisation a system architecture issue.
EMA HTTP schema disabling: how to prevent issues in ICSR submissions
Disabling HTTP for EMA XML schemas impacts ICSR submission via Gateway and EVWEB. Here are the deadlines, technical impact, and compliance requirements.
SD Collection, the pharmacovigilance magazine
The latest edition of SD Collection, the SafetyDrugs special with insights, updates and useful advice on pharmacovigilance is now available.
MedDRA 28.1: what’s new for pharmacovigilance from terminology to the Desktop Browser
In September 2025, MedDRA version 28.1 was released, the [...]
GVP Module VI Addendum II: how to comply with the new EMA Rules on ICSR data
GVP Module VI Addendum II issued by EMA introduces new rules on the processing of personal data in ICSRs submitted to EudraVigilance. Here is what changes and how to be compliant.
MedDRA 28.0: what’s new in the latest version
MedDRA 28.0 has been released: the latest version of the internationally adopted medical regulatory dictionary. Here are the main news.
MedDRA: what it is and why it is essential in pharmacovigilance
An in-depth look at MedDRA: its structure, hierarchical levels, multi-axiality, and applications. Discover why it's a crucial tool in coding and analyzing pharmacovigilance data.
Pharmacovigilance data protection: how we guarantee maximum security
Pharmacovigilance data protection is an essential element and to guarantee security we have relied on Oracle for years.
Pharmacovigilance ICSR management: 10 benefits of the safety database
The safety database is a fundamental tool for efficient pharmacovigilance ICSR management. Here are the main advantages of using it.
ICSR transfer outside of EU: how to comply with the GDPR with SafetyDrugs
The ICSR transfer outside of EU entails risks in terms of compatibility between pharmacovigilance agreements and GDPR. Here's how be compliant.
Signal Validation: what is it and how to perform it
Signal Validation is the activity of verifying the reliability and completeness of the information supporting a potential signal. Here's how it's done according to GVP.
Signal Detection in pharmacovigilance: what it is and how it works
Signal Detection plays a fundamental role in the constant monitoring of the safety profile of a drug. Through this analysis it is possible to promptly identify possible signals of adverse effects associated with the use of a drug. Here's what Signal Detection is and how it's done.
How to choose a safety database: the guide
Here are the best features to look for understand how to choose a safety database
Why a safety database is convenient for pharmaceutical companies?
A safety database is a fundamental tool for complying with pharmacovigilance regulations, allowing you to save time and resources. Here it is the reasons why a safety database is convenient for pharmaceutical companies.
EDQM standard terms: mandatory for Dosage Forms and Route of Administration
The EDQM standard terms will be mandatory starting for the indication of dosage forms and routes of administration in pharmacovigilance reports. Here's the news.