B19. CMC variations: Navigating the greyzones
Tracks
Prescription Medicines Regulation
| Thursday, June 13, 2024 |
| 2:45 PM - 3:45 PM |
| C2.2+C2.3 |
Chair & Speakers
Kaysia Wilson
Consultant
Adjutor Healthcare Pty Ltd
Chair:CMC variations: Navigating the greyzones
Biography
Since her regulatory journey began in 2019, Kaysia has worked on a diverse range of over the counter (OTC) and prescription medicines, within different therapeutic areas, in the pharmaceutical industry and in consulting, across Australia and New Zealand.
Kaysia has developed regulatory strategies and has been a project manager for a variety of medicines and clients. Her experience includes submission of new prescription medicines, variations, and other complex applications to the Therapeutic Goods Administration (TGA) in Australia.
Kaysia holds a Bachelor of Pharmaceutical Science from Monash University, Australia.
Stephanie De Dios
Director, Biomedicines Evaluation Section , Laboratories Branch,
Department of Health and Aged Care (TGA)
CMC variations: Navigating the greyzones
Abstract
During COVID, TGA have prioritise post market variations (CMC) due to emergency use medicines and medicine shortages, resulting in other CMC applications being approved later. The current Australian regulations restrict companies from implementing post market changes that are deemed low risk prior to being evaluated by TGA. The process is burdensome as it can cause bottlenecks in the supply chain.
Through this workshop TGA will share insights with the industry on how to evaluate post-market variations that fall into the grey zone when a change does not fall into any one category, using examples provided from industry. Below are a few examples but would need to source more complex examples from other industry groups so that changes can relate to Biologics/ biosimilars, and medicine changes.
1. In accordance with EMA guidelines on post-approval changes, SOP revisions in Europe can be filed as notifications/ "Do & Tell". Such changes require prior approval in Australia. Even minor changes when categories are not specified would be classified as Cat 3 (i.e., changes that are editorial in nature and improve method clarity).
2. Addition of ID or visual inspection machine, where there is no change to the process but the documentation has been updated.
Through this workshop TGA will share insights with the industry on how to evaluate post-market variations that fall into the grey zone when a change does not fall into any one category, using examples provided from industry. Below are a few examples but would need to source more complex examples from other industry groups so that changes can relate to Biologics/ biosimilars, and medicine changes.
1. In accordance with EMA guidelines on post-approval changes, SOP revisions in Europe can be filed as notifications/ "Do & Tell". Such changes require prior approval in Australia. Even minor changes when categories are not specified would be classified as Cat 3 (i.e., changes that are editorial in nature and improve method clarity).
2. Addition of ID or visual inspection machine, where there is no change to the process but the documentation has been updated.
Biography
Dr Stephanie de Dios is the Director of the Biomedicines Evaluation Section in the Laboratories Branch at the Therapeutic Goods Administration. She has a bachelor’s degree in Applied Chemistry (Hons), Masters of Business and a PhD from Monash University. Prior to joining the TGA, she spent a majority of her academic career in cardiovascular disease and diabetes medical research at University of New South Wales, Melbourne University and Monash University. She has served in the TGA for almost 13 years, initially as a Senior Toxicologist prior to becoming the Director of the Biomedicines Evaluation Section – Responsible for the evaluation of manufacturing quality data for the pre market (registration) and post-market (variation) of all vaccines, including influenza, COVID 19 and RSV, as well as other therapeutic products, such as anti-venoms and toxins.
Jeff Webb
Director, Pharmaceutical Chemistry Variation Section, Scientific Evaluation Branch
Department of Health and Aged Care (TGA)
CMC variations: Navigating the greyzones
Abstract
During COVID, TGA have prioritise post market variations (CMC) due to emergency use medicines and medicine shortages, resulting in other CMC applications being approved later. The current Australian regulations restrict companies from implementing post market changes that are deemed low risk prior to being evaluated by TGA. The process is burdensome as it can cause bottlenecks in the supply chain.
Through this workshop TGA will share insights with the industry on how to evaluate post-market variations that fall into the grey zone when a change does not fall into any one category, using examples provided from industry. Below are a few examples but would need to source more complex examples from other industry groups so that changes can relate to Biologics/ biosimilars, and medicine changes.
1. In accordance with EMA guidelines on post-approval changes, SOP revisions in Europe can be filed as notifications/ "Do & Tell". Such changes require prior approval in Australia. Even minor changes when categories are not specified would be classified as Cat 3 (i.e., changes that are editorial in nature and improve method clarity).
2. Addition of ID or visual inspection machine, where there is no change to the process but the documentation has been updated.
Through this workshop TGA will share insights with the industry on how to evaluate post-market variations that fall into the grey zone when a change does not fall into any one category, using examples provided from industry. Below are a few examples but would need to source more complex examples from other industry groups so that changes can relate to Biologics/ biosimilars, and medicine changes.
1. In accordance with EMA guidelines on post-approval changes, SOP revisions in Europe can be filed as notifications/ "Do & Tell". Such changes require prior approval in Australia. Even minor changes when categories are not specified would be classified as Cat 3 (i.e., changes that are editorial in nature and improve method clarity).
2. Addition of ID or visual inspection machine, where there is no change to the process but the documentation has been updated.
Biography
Mr Webb is currently the acting Principal Evaluator of the Pharmaceutical Chemistry Variations Section of the Therapeutic Goods Administration (TGA). The Section is responsible for the evaluation and approval of post-market quality changes to prescription medicines.
Mr Webb is a chemist by training obtaining a Bachelor of Science in Chemistry and Microbiology at the University of South Australia. Prior to joining the TGA and has previously worked in various industry roles supporting the quality and bioanalytical aspects of manufacturing and drug research.
