IGMPI India

The US FDA (Food and Drug Administration) has issued draft guidance on the established conditions: Reportable Chemistry, Manufacturing and Control (CMC) changes for approved drug and biologic products. The regulator expects the biopharmaceutical industry to provide their comments before July 31, 2015.

The regulator said “Although the reporting mechanism for many CMC changes is clear, FDA is concerned that there is confusion regarding which elements of an application are considered to be established conditions. This confusion could have a negative impact on change management activities and could discourage continual improvement in product manufacturing processes. It could lead to unnecessary submission of post-approval supplements to FDA for changes that could be managed solely by a manufacturer’s product quality system (PQS) and lead to Form 483 observations. The recommendations in this guidance pertaining to submission of information about established conditions in original applications, supplements, and annual reports are intended to increase clarity and transparency and help avoid such potentially negative outcomes”.

Clarity on what constitutes an established condition will also provide FDA with pathways to better regulate post-approval changes by utilizing more flexibility and risk-based principles, in accordance with the Current Good Manufacturing Practices.