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November 2023

Safety Observer 205

Kenya updates guidelines describing Pharmacovigilance obligations of MAHs in the country.

Released 09-Nov-2023
Pages 37
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Report 205 — Highlights

FDA Guidance on BRA

The FDA has published its final guidance on Benefit-Risk Assessment (BRA), which clarifies how these considerations factor into FDA’s regulatory decisions.

FDA Off-Label Guidance

The FDA has published a revised draft guidance for comments, which covers common questions regarding the communication of scientific information on unapproved use(s) of marketed products.

ePI Pilot in the EU

The EMA has announced that a first set of ePIs (electronic Product Information) has been published as part of the pilot project to test the use of ePI based on the Common Standard adopted in 2022.

New PV Guidelines in Kenya

The Pharmacy and Poisons Board of Kenya has published updates to the guidelines that describe the obligations of Marketing Authorisation Holders in the country.

Partner Audits Toolkit

The Pharmacovigilance Agreements Optimization (PVAO) Initiative of TransCelerate has produced a new toolkit that includes a suite of solutions to help with Marketing Partner Audits.

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