Address
304 North Cardinal St.
Dorchester Center, MA 02124
Work Hours
Monday to Friday: 7AM - 7PM
Weekend: 10AM - 5PM
The EMA’s Committee for Medicinal Products for Human Use (CHMP) reviewed several marketing authorisations and safety evaluations. Emphasis was placed on post-authorisation measures and pharmacovigilance follow-ups for biological and biosimilar medicines.
What This Means for You:
Sponsors and MA Holders should ensure ongoing PV reporting (PSURs, RMP updates) and maintain inspection-ready documentation. If using eTMF systems, confirm that submission-linked safety documents are traceable and current.