Pharma GMP News of the Week: 26-June-2022
Period: June 19, 2022 to June 25, 2022
News from CDSCO India, Ministry of Health’s proposal to add barcodes or quick response (QR) codes on around 300 top medicines to provide authentication. It will come into force in May 2023.
Government Document dated: June 14, 2022
US FDA issued Draft guidance “Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures”
Date of guideline issuance: June 21, 2022.
Source: https://www.fda.gov/media/159294/download
News from ICH “The ICH Q3D(R2) Introductory Training Presentation is now available on the ICH website”
Date of news: June 23, 2022
As per the news from ICH, A Step 4 Introductory Training material is developed and it is available on the website.
Source: https://database.ich.org/sites/default/files/ICH_Q3D%28R2%29_Step4Presentation_2022_0527.pdf
US FDA published draft guidance on “Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination”
Document issued on: June 24, 2022
The purpose of this guidance is to provide information of facility design elements, methods, and controls required to prevent product being cross-contaminated with compounds containing a beta-lactam ring.
It covers probable health risk, and the potential for cross-reactivity in the classes of non-antibacterial beta-lactam compounds and non-penicillin beta-lactam antibacterial drugs .
Source: https://www.fda.gov/media/159358/download
US FDA published final guidance on “Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry”
Document issued on: June 24, 2022
The purpose of this guidance is to provide suggestions on an alternate electronic format required to be submitted under an exemption from or a waiver of the provisions of FD&C Act, section 745A(a).
The scope of this guideline are:
NDAs, ANDAs, certain DMFs, BLAs, and INDs submitted to the CDER or CBER.
Source: https://www.fda.gov/media/159388/download
US FDA published final guidance on “Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations”
Document issued on: June 24, 2022
The purpose of this guidance is to provide suggestions to the applicants who are planning to perform food-effect (FE) studies for orally consumed drug products under INDs to support NDAs and supplements to these applications for drugs being developed under section 505 of the FD & C act. This document replaces and revises part of the 2002 FDA guidance entitled Food-Effect Bioavailability and Fed Bioequivalence Studies (December 2002).
Source: https://www.fda.gov/media/121313/download
MHRA update the guidance “Guidance on handling of Decentralised and Mutual Recognition Procedures which are approved or pending”
Document update: June 24, 2022
MHRA has updated the guidance to include Section ‘Guidance for The Conversion of PLGB or PLNI licences to PL’
