Welcome to the 2nd edition of Regulatory News – a monthly digest for RA professionals. Each edition summarises key regulatory developments from the previous month, spanning guidance, reviews, safety signals, and innovation. This edition includes highlights from EMA, FDA, and selected RoW markets. RoW focus rotates by region – this month: South Korea and Switzerland. This is my take on developments that may influence regulatory strategy or day-to-day RA work. As always, please consult official sources or dedicated intel teams for comprehensive coverage and tailored insights. I hope this digest helps you stay oriented, inspired, and prepared in an ever-evolving regulatory landscape. About Me Pascale Jean – Regulatory Affairs and Pharmacovigilance expert I have 20+ years of experience in the pharmaceutical industry, with 12 of those in RA and 9 years in Pharmacovigilance. I combine a solid understanding of drug development with strong skills in submission leadership and cross-functional submission

EMA Highlights | FDA Highlights | Row Highlights Editor’s Note: Welcome to the first issue of Regulatory News – a monthly digest with regulatory news and updates that I believe are relevant for RA professionals. �� Link to Pdf for downloading In each issue, you’ll find a brief, structured summary of highlights published during the previous month. This issue focuses on regulatory and guidance news from June 2025. It covers essential developments in trial inclusivity, Real World Evidence, and innovations in review processes, like artificial intelligence and harmonized protocols. I hope that the Regulatory News will help you stay oriented, inspired, and prepared in an ever-changing regulatory environment. About Me Pascale Jean – Regulatory Affairs and Pharmacovigilance expert I have 20+ years of experience in the pharmaceutical industry, with 12 of those in RA and 9 years in Pharmacovigilance. I combine a solid understanding of drug development with strong skills in