IGDRP presents guidance document on assessment of active substances
5 diciembre 2017

The International Generic Drug Regulators Programme (IGDRP) recently released a guidance document intended to help regulatory agencies’ quality assessors review technical information on active substances.

“In line with IGDRP’s broader objectives, the IGDRP believes that the publishing of this guidance may also be of benefit to national regulatory agencies who are not members of IGDRP, and to parties responsible for the preparation of quality information that is submitted to regulatory agencies,” states the body’s communication.

The document was drafted by regulators from Australia, Canada, Singapore and Switzerland to aid review the technical information contained in the Quality Module (Module 3) of Active Substance Master Files (ASMFs) /Drug Master Files (DMFs) and marketing authorisation applications (MAAs). It outlines the recommended components in the evaluation of the Quality Module. Each regulatory agency may require additional components beyond the elements considered in this guide depending on their legislative, regulatory, and policy requirements and review practices.

The section “Notes on the Preparation of the Quality Assessment Report (QAR)” outlines 14 aspects that regulators should bear in mind when carrying out the technical assessment of the Quality Module, including summaries of the critical assessments and scientific discussions reflecting the agency’s views on the information.

The document also states what information should be included in the QAR regarding general information, manufacturing, characterization, control of the drug substance, reference standards or materials, container closure system and stability.

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