EMA is launching new initiatives focusing on better integration of women’s health considerations into medicines development and regulation.
Incorporate enhanced requirements for monitoring pregnancy-specific safety signals into existing pharmacovigilance practices.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Initiatives include detailed analyses of CTIS data for women's representation, improving methods for pregnancy-specific safety signal detection, developing pregnancy pharmacoepidemiologic methodological guidance, and strengthening pharmacovigilance practices with specific guidelines for pregnancy and breastfeeding.
MAHs and sponsors can expect enhanced requirements for pregnancy-specific safety signals, new methodological guidance for safety studies in pregnant populations, and updated PV practices for monitoring safety in women.
MAHs and sponsors can expect enhanced requirements for pregnancy-specific safety signals and new methodological guidance for safety studies in pregnant populations.
These initiatives will likely improve drug safety assessments for women, particularly regarding pregnancy and breastfeeding, ensuring better health outcomes for this demographic.
Incorporate enhanced requirements for monitoring pregnancy-specific safety signals into existing pharmacovigilance practices.
Suppliers must implement new protocols for safety reporting and record-keeping as per the proposed framework.
MAHs must ensure new medicinal product information texts use updated templates by 1 July 2026 and revise existing texts at the earliest opportunity if they include instructions for use.
Manufacturers must implement processes for device registration in swissdamed before placing devices on the market, with immediate attention needed for vigilance-reportable incidents.
Manufacturers must adjust labeling workflows to incorporate e-labelling mechanisms, such as QR codes, for P and GSL medicines by the stipulated date.
