Two key thrusts of EMA’s “Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials” will be to provide flexibility in shelf-life determination for IMPs and to facilitate harmonization of the clinical trial application process across the EU.
As the guideline reaches its final stage, EMA’s Head of Biologicals Peter Richardson has been emphasizing at recent industry/regulator forums that the lack of shelf-life flexibility and EU harmonization have been sticking points previously for industry in the IMP CMC arena that the guideline should help resolve.
The investigational products guideline was out for public comment last year for a six month period that ended in August. The comments are currently being assessed by the EMA’s Biological Working Party (BWP), which has primary responsibility for drafting the guideline, and the final version is expected soon. The guideline will cover documentation requirements for biological and biotech products used in Phase I, II and III clinical trials.
[Richardson’s insights on the EMA’s key biological initiatives that he gave this spring at CASSS’ CMC Strategy Forum Europe in Barcelona and at the PDA/EMA Conference in London are provided for subscribers here. Nonsubscribers can purchase the story for $195 by contacting Peter Blachly (email@example.com). For subscription/license information, click here]
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