Safety Observer 192
A new FDA draft guidance explains how generic sponsors will be able to submit electronic Safety Reports to FAERS.
Report 192 — Highlights
CIOMS XI
CIOMS has announced the publication of its latest report on “Patient involvement in the development, regulation and safe use of medicines”. The topics covered include Safety Communication, Additional Risk Minimisation, etc.
ICH M12
The ICH M12 draft Guideline on Drug Interaction Studies has entered the consultation period and multiple authorities are now calling for comments, including the US FDA and the EMA.
FDA & E2B ICSRs
The FDA has published a new draft guidance for comments, which covers “Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies”. Once FAERS enhancements are activated, generic sponsors will be able to transmit these reports in E2B format.
MHRA & eSUSAR
The MHRA has announced that the eSUSAR website will be decommissioned on 30-Sep-2022. Subsequently, SUSARs will only be accepted via the ICSR Submissions portal.
Pakistan: PV Guidelines
The Drug Regulatory Authority of Pakistan (DRAP) has published for consultation the draft of the 2nd Edition of National Pharmacovigilance Guidelines.
