United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
This guidance provides a framework to facilitate the management of postapproval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient manner. A harmonized approach regarding technical and regulatory considerations for lifecycle management will benefit patients, industry, and regulatory authorities by promoting innovation and continual improvement in the pharmaceutical sector, strengthening quality assurance, and improving supply of medicinal products. The concepts outlined in prior ICH Quality guidances for industry (ICH Q8(R2), Q9, Q10, and Q11) provide opportunities for science- and risk-based approaches for use in drug development and regulatory decisions. These guidances are valuable in the assessment of CMC changes across the product lifecycle. ICH Q8(R2) and Q11 guidances focus mostly on early stage aspects of the product lifecycle (i.e., product development, registration, and launch). This guidance addresses the commercial phase of the product lifecycle (as described in ICH Q10) and it both complements and adds to the flexible regulatory approaches to postapproval CMC changes described in ICH Q8(R2) and Q10 Annex 1. This guidance is also intended to demonstrate how increased product and process knowledge can contribute to a more precise and accurate understanding of which postapproval changes should result in a regulatory submission as well as the definition of the levels of reporting categories for such changes (i.e., a better understanding of risk to product quality). Increased knowledge and effective implementation of the tools and enablers described in this guidance should enhance industry’s ability to manage many CMC changes effectively under the company’s Pharmaceutical Quality System (PQS) with less need for extensive regulatory oversight prior to implementation. This approach can incentivize continual improvement by providing an opportunity for greater flexibility in making postapproval changes. It could also result in fewer associated postapproval submissions to the Marketing Authorization Application (MAA) and less associated regulatory burden. The extent of this operational and regulatory flexibility and its adequate implementation is subject to the regulatory framework in place, as well as product and process understanding (ICH Q8(R2) and Q11), application of quality risk management principles (ICH Q9), and an effective PQS (ICH Q10).
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)