Regulatory intelligence & pharmacovigilance updates, mapped to your role.

What changed

MAHs and sponsors must now use the updated IRIS portal for safety reporting and signal management, effective June 15, 2026.

Why it matters

Compliance with the latest digital submission standards is essential for regulatory submissions in the EU, impacting pharmacovigilance-related processes.

What changed

The guide specifies that all submissions related to pharmacovigilance and safety in the EU must utilize the IRIS system for registration, with the requirement to request a new Research Product Identifier (RPI) if not already associated with an existing one.

Why it matters

Accurate registration and management of RPIs are essential for compliance with EU pharmacovigilance regulations, ensuring that organizations can effectively engage in safety monitoring and regulatory submissions.

What changed

Mandatory submission of non-clinical study data in SEND format is established for new authorisation applications for NAS, effective 15 June 2026.

Why it matters

This change aims to standardize the initial safety data submitted in marketing authorisation dossiers, facilitating faster safety reviews and aligning with global standards such as those from the FDA and PMDA.

What changed

The SFDA has released Version 4.0 of its regulations, which implements updated definitions, requires that observational Phase IV trials comply with GVP guidelines, mandates consultation for risk minimization studies, and introduces specific requirements for Post-Trial Access Programs effective from 2026-06-28.

Why it matters

These changes will significantly impact clinical trial conduct in Saudi Arabia, ensuring better safety monitoring and alignment with global standards. Failure to comply may result in regulatory penalties or modifications to trial approval.

What changed

Clinical trial sponsors and investigators must review and comply with the updated ISO 14155 standards for medical device clinical safety reporting, especially in light of the discussions regarding N=1 therapeutics and their ethics oversight.

Why it matters

The discussions emphasize the importance of robust ethics oversight and safety monitoring for personalized therapeutics, ensuring that clinical trials adhere to the latest standards.