Regulatory intelligence & pharmacovigilance updates, mapped to your role.

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

Ensure compliance checks are reinforced in the inspection readiness processes to account for potential non-compliance surrounding product imports.

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.

Clinical safety and pharmacovigilance teams should review the FDA guidance and adjust their monitoring plans to ensure they align with the newly provided recommendations regarding safety endpoints and data collection processes.

Marketing Authorisation Holders (MAHs) and applicants must register new sites and organisations in the OMS before any regulatory submission and ensure alignment of their submission documents with the latest guidelines.

Notified Bodies and medical device manufacturers should adhere to the updated requirement of using the IRIS platform for notification and submission processes concerning companion diagnostics, ensuring compliance with the new timelines and submission methods.

Ongoing investigations into unlawful vaping products are expected to result in further enforcement actions, including additional seizures and potential penalties for non-compliance with the Therapeutic Goods Act.

Regulatory intelligence workflows should address this enforcement action as part of ongoing compliance monitoring regarding the sale and promotion of unapproved therapeutic goods.