FDA Finalizes Guidance on Providing Postmarket Safety Reports in ICH Format

Posted 29 November 2016 By Zachary Brennan


The US Food and Drug Administration (FDA) on Tuesday finalized guidance describing the conditions under which companies can use an alternative reporting format to satisfy postmarketing safety reporting requirements.

The guidance explains the intricacies of how applicants can use an alternative reporting format, known as the International Council for Harmonisation (ICH) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER), in place of the US periodic adverse drug experience report (PADER), US periodic adverse experience report (PAER) or ICH E2C Periodic Safety Update Report (PSUR), to satisfy the periodic postmarketing safety reporting requirements.

The 10-page guidance, endorsed by ICH in 2012 and first released by FDA as a draft in April 2013, also describes the procedures applicants should follow if they wish to submit a PBRER in place of a PADER, PAER or PSUR.

Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) Guidance for Industry

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Categories: Biologics and biotechnology, Drugs, Due Diligence, Research and development, Quality, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA, ICH

Tags: ICH guidance, PSUR, PAER, PADER, PBRER

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