PV in clinical trials

Clinical safety and pharmacovigilance teams must ensure that their SUADR reporting processes are aligned with the new 7-day and 15-day notification timelines, and maintain robust systems for collecting safety data from international sites.

Stakeholders must prepare for discussions about the integration of QSP methods in investigational new drug (IND) submissions, including a review of IND data packages to align with the new recommendations.

Sponsors and investigators must develop an implementation plan for the ISO 14155:2026 standard and maintain records for review during TGA inspections, ensuring alignment with updated safety monitoring obligations.

MAHs and sponsors must review and potentially update internal SOPs and reporting forms that currently reference 'gender' to ensure compliance with the updated terminology and definitions.

Map this update to local PV compliance processes and update SOP/work instructions, ownership, and due dates for implementation evidence.

Holders of Certificates of Registration and Clinical Research Organisations must update their safety databases and reporting workflows to comply with the new electronic reporting requirements for AEs and SAEs.

Clinical trial sponsors must update their internal SOPs for safety reporting and ensure staff are trained on the new submission steps for ASRs through the CTIS platform.

Investigators need to modify trial protocols and safety reporting mechanisms in line with the latest ISO 14155 updates to ensure compliance for upcoming high-risk clinical trials.

Safety lead to: (1) perform a UK-clinical-trial safety reporting gap assessment against MHRA’s effective guidance sections (MedDRA coding; AE/SAE; RSI governance; SUSARs; annual safety reporting; USMs; serious breaches; temporary suspension), (2) update controlled SOPs/WIs and training records to reflect “effective” status as of 28 Apr 2026, and (3) document deviations/gaps and open CAPA where needed for ongoing UK trials and new submissions.

Ensure compliance with updated SUSAR reporting timelines (15 days), notify SFDA of Phase IV trials within 20 working days post-IRB approval, and prepare for the financial fee of 15,000 Saudi Riyals for clinical trial evaluations.

Organizations must establish an active EMA user account, ensure they have a valid EMA customer account number, and complete the SPOR/OMS registration process within five to ten working days if not previously registered.

Ensure all relevant teams are prepared to transition to the mandatory SEND format for data submissions by the effective date of 15 June 2026.

Review and update data submission practices to align with the new technical specifications; ensure compliance with FDA-supported data standards.

Clinical trial sponsors must update internal standard operating procedures (SOPs), conduct staff training on the functionality of the new ASR module, and utilize the CTIS training environment to ensure readiness for compliance with the new workflow.

Confirm child is 24 months or older before administering FluMist; review Product Information; verify patient age against indication.

Patients will be treated with an initial dose of 19 mg of Mimrylo, administered weekly, with careful monitoring to maintain hematocrit levels below 45%. The operation of post-marketing surveillance will be affected due to the introduction of this new drug.

Labeling and risk management updates are required to reflect the new drug approval, including the incorporation of safety and efficacy data from the VERIFY trial.

Initiate the update of labeling materials for Rasonque to reflect the new FDA approval and ensure compliance with reporting requirements for newly approved therapies.

Healthcare professionals must include daraxonrasib in adverse event reporting as the new treatment option is now available for eligible patients.

Healthcare providers and manufacturers must now comply with new reporting obligations for adverse reactions associated with the use of Imaavy and ensure adherence to increased compliance requirements for its administration.

Clinical investigations must now include justification for DDM selection and ensure that DHTs are verified and validated to support their intended clinical role.

Developers of MBMPs must align their safety assessment protocols with the MHRA's expectations and are encouraged to engage with the MHRA early to establish appropriate regulatory strategies.

Stakeholders must prepare for changes in how early-phase safety data is reported and engage in the continuous safety dialogue encouraged by the FDA. Ensure timely submission of comments by July 22, 2026.

Stakeholders are encouraged to utilize the provided e-learning modules to improve their inspection readiness and compliance with GCP standards in Australia.

Clinical safety and pharmacovigilance teams must implement new safety monitoring protocols and ensure adequate assessment of abuse potential as stipulated in the guidance.

Incorporate enhanced requirements for monitoring pregnancy-specific safety signals into existing pharmacovigilance practices.

CTIS users are now required to actively monitor notifications daily to ensure timely awareness of safety-related tasks.

MAHs and trial sponsors must align their safety monitoring and data collection workflows with the new GCP principles established in ICH E6(R3) Annex 2.

Utilize the IB template provided for cell therapy products in clinical trial applications, available under the 'Special Product Areas' section of the Danish Medicines Agency's website.

Sponsors and MAHs must replace the 2021 form with the new 2026 approved form for all six-monthly reports on unapproved therapeutic goods supplied under SAS and CTA schemes.

MAHs should prepare for enhanced regulatory collaboration, including potential joint oversight activities and reduced market friction between the UK and US due to closer alignment in regulatory decisions.