Safety Observer 189
The FDA published the final guidance for the electronic submission of Postmarketing Safety Reports.
Report 189 — Highlights
FDA & E2B submissions
The US FDA has published the final guidance entitled “Providing Submissions in Electronic Format – Postmarketing Safety Reports”. The FDA also published updated guidance to help companies prepare their systems for the transition to the E2B(R3) format.
Canada: e-labelling
Health Canada has adopted interim implementation measures whereby companies can choose to use electronic platforms to complement physical labels for prescription medicines.
South Africa: PV Inspections
The South African Health Products Regulatory Authority (SAHPRA) has published a new guideline on “Pharmacovigilance Inspections for Human Medicinal Products”.
Janssen COVID-19 Vaccine
The US FDA has announced its decision to limit the authorized use of the Janssen COVID-19 Vaccine to adults for whom no other COVID-19 vaccine can be used.
DILI e-learning
Following the publication of the consensus report on Drug-Induced Liver Injury (DILI) in September 2020, CIOMS and the UMC have produced the corresponding e-learning course.
