Regulatory intelligence & pharmacovigilance updates, mapped to your role.

Immediate compliance is necessary for MAHs to implement SPPs, including documenting production and supply capacities and establishing internal collaborative processes across supply chain, regulatory, and pharmacovigilance teams.

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.

Marketing authorization holders must transition to the updated PLM Portal eAF by the mandatory deadline of September 1, 2026, ensuring correct submission of variations, particularly those related to pharmacovigilance.

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.

Stakeholders involved in biosimilar product development must review the draft guidance, focus on comparative safety assessments, and submit relevant comments by the deadline of October 2, 2026.

Clinical safety and pharmacovigilance teams must update their study protocols and adverse event reporting procedures to align with the revised guidance by October 2, 2026.

Manufacturers and applicants must utilize the finalized scoring system for new study submissions and ensure post-market safety reports include monitoring for adhesion-related issues as indicators of product quality.

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.