EMA’s finalized guideline on “the requirements for quality documentation concerning biological investigational medicinal products in clinical trials” reflects significant changes made to the draft resulting from extensive industry/regulator dialogue and marks an important step in the agency’s efforts to harmonize requirements in the clinical and biotech arenas across Europe.
One important change made in the final version as a result of the dialogue is the ability for sponsors to extrapolate shelf life of the investigational product beyond the period covered by long term, real-time stability studies, provided that the extension is supported by relevant data, including accelerated stability studies.
The guideline applies to proteins and polypeptides, their derivatives, and products of which they are components (e.g. conjugates), produced from recombinant or non-recombinant cell culture expression systems. The principles may also apply to other product types such as proteins and polypeptides isolated from tissues and body fluids.
Responsibility for the approval of a clinical trial application (CTA) in Europe resides at the state level. Each of the EU’s 27 member states is responsible to approve applications for trials in its own country.
Varying experience levels of both sponsors and competent authorities with biotech products, and differing requirements across the member states, have made registration of trials for biologics problematic. The new guideline attempts to address these discrepancies by serving as a common reference for the evaluation of the quality of a biological CT material.