Pharma GMP News of the Week: 7-August-2022

Period: July 31, 2022 to August 6, 2022

US FDA has published draft guideline on “Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry”

Date of news: August 2, 2022

The purpose of this draft guideline is to assist ANDA applicants while submitting expedited safety reports of serious adverse events BA/BE studies in electronic form.  

Serious adverse events have been submitted to the Office of Generic Drug through telephone, email, or facsimile transmission as attachments.  

This document provides recommendations,  specifications, and general considerations to send electronic submission of expedited safety reports. 

Source: https://www.fda.gov/media/160561/download 

MHRA is decommissioning of Suspected Unexpected Serious Adverse Drug Reactions (SUSARs)

Date of news: August 3, 2022

The MHRA is decommissioning the eSUSAR website to support Individual Case Safety Reports (ICSR) Submissions; providing users a more stringent, robust, and transparent process of SUSARs from Clinical Trials of Investigational Medicinal Products.

Source: https://mhrainspectorate.blog.gov.uk/2022/08/03/decommission-of-esusar/ 

News from EDQM – Deadline extension for Nitrosamines for all CEP holders to accomplish step 3 Revision to the CEP is October 1, 2023

Date of news: August 4, 2022

EDQM has published on its website that the European medicines regulatory network has agreed to provide extra time for submissions of Step 3, i.e. variation to the MA until October 1, 2023. 

The extension is provided to allow organizations time to perform an adequate and detailed investigation and identify any required risk-mitigating actions. 

However, the timeline for Step 2: confirmatory testing remains unchanged, i.e. September 26, 2022.

Source: https://www.edqm.eu/en/-/nitrosamines-deadline-extension-to-all-cep-holders-to-complete-step-3-revision-to-the-cep-now-1st-october-2023-.

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