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We will then focus on some of the CMC topics requiring special attention when preparing a dossier for a biological product based on our experience with recent submissions.
Below is a chronological presentation of each regulation and guidance document, including the impact they had on the presentation of quality information within the IMPD.
This article discusses the evolution of the EU regulatory expectations related to the IMPs and how these expectations have influenced the required quality information to include in the IMPD for biological products.
First, an overview of regulations, guidelines and events, impacting quality requirements of IMPs, will be presented together with a brief summary of the two procedures currently available for submission of CTAs in the EU.
The IMPD provides quality and non-clinical data on the IMP, in addition to data from previous clinical trials and human experience to evaluate the benefits and risks associated with the administration of an IMP during the conduct of the clinical trial.
The Quality section of the IMPD, describing all aspects of the Chemistry, Manufacturing and Control (CMC) of the product under investigation, plays an important role in ensuring safety and establishing the scientific relevance of the IMP along with already completed non-clinical and clinical studies.
Currently, before a clinical trial can be conducted in one EU/EEA MS, a Clinical Trial Application (CTA) has to be submitted and approved by each concerned CA and EC.
Issued in 2001, Directive 2001/20/EC describes the law and regulations relating to the conduct of clinical trials on IMP for use in humans.