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September 2022

Safety Observer 192

A new FDA draft guidance explains how generic sponsors will be able to submit electronic Safety Reports to FAERS.

Released 07-Sep-2022
Pages 42

Report 192 — Highlights


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.


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.


The FDA has published a new draft guidance for comments, which covers “Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies”.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.


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.

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