Table 9.

Postmarketing surveillance: additional regional guidances on signal detection beyond ICH guidelines

Country/region	Signal detection
Australia	TGA Pharmacovigilance Responsibilities of Medicine Sponsors: Report signal of a possible teratogenic effect (cluster of cases) as a significant safety issue [33]
EU	EMA Guideline on the Exposure to Medicinal Products During Pregnancy—Need for Post-Authorisation Data: Additional guidance on how to perform signal detection for pregnancy cases [29]
Saudi Arabia	SFDA Guideline on GVP (v3.1): Immediately notify about potential signals of teratogenicity [34]
Switzerland	Swissmedic: Additional guidance regarding potential/identified signals of teratogenicity [35]

EMA European medicines agency, EU European union, GVP good pharmacovigilance practices, ICH international council for harmonisation of technical requirements for pharmaceuticals for human use, SFDA Saudi food and drug authority, TGA therapeutic goods administration