Pharma GMP News of the Week: 21-August-2022
Period: August 14, 2022 to August 20, 2022
FDA published Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
Date of news: August 15, 2022
The purpose of guidance is to assist in transmitting electronic individual case safety reports and ICSR attachments to the FDA Adverse Event Reporting System (FAERS) database. An individual case safety reports (ICSRs) is a description of an adverse experience related to an individual patient or subject.
Source: https://www.fda.gov/media/98536/download
News from ICH “Addendum to S1B reaches Step 4 of the ICH Process”
Date of news: August 15, 2022
This document has been signed off on August 4, 2022. The document is developed based on a Concept Paper of Nov 14, 2012 and a Business Plan.
This addendum to ICH S1B is supported by scientific advances. Many retrospective study conducted by the agency confirmed that an integrative Weight of Evidence approach could be applied to adequately assess the human carcinogenic risk for certain pharmaceuticals in lieu of conducting a 2-year rat study without compromise to patient safety.
As per the ICH, this is a more integrative and comprehensive approach to assessing human carcinogenic risk of pharmaceuticals.
Source: https://database.ich.org/sites/default/files/ICHS1B%28R1%29_Step4_Presentation_2022_0809.pdf
News from EDQM “11th edition of the European Pharmacopoeia now available in print”
Date of news: August 17, 2022
Source: https://www.edqm.eu/en/-/11th-edition-of-the-european-pharmacopoeia-now-available-in-print-1
India’s NPPA to take web portals offline from the 17 to 28 of August to upgrade pharma database
Month of news: August 2022
India’s National Pharmaceutical Pricing Authority (NPPA)’s web portal is offline from the 17 to 28 of August to upgrade the system. Therefore, Pharma Jan Samadhan, which is the government’s Digital India initiative if affected. The Integrated Pharmaceutical Database Management System (IPDMS) will be upgraded to enable companies to comply with the mandatory reporting requirements set out in the Drugs (Prices Control) Order, 2013.
Meanwhile, the agency will accept complaints regarding the nonavailability, overpricing, sales without price approval, shortage of drugs, and the refusal to supply medicines through email.
Source: https://www.nppaindia.nic.in/wp-content/uploads/2022/08/Auto-Color0112.pdf
