The EMA has published final guidelines on manufacturing quality documents needed for biologics entering clinical trials.
Release of the final guidelines comes more than two years after a working party at the European Medicines Agency (EMA) agreed on a draft. In the guidelines the EMA outlines what information manufacturers should supply when trying to move a biologic into clinical trials.
“The names and addresses and responsibilities of each manufacturer, including contractors, and each proposed production site or facility involved in manufacture, testing and batch release should be provided”, the EMA wrote in its final guidelines on biological investigational medicinal products .
Other sections of the guidelines delve deeper into the production process, asking companies to give details of the manufacturing process, raw material sources, and control of the active substance.
In an acknowledgement of the developmental nature of biologics in clinical trials the EMA guidelines give biopharma manufacturers scope to improve production processes. Manufacturers optimising processes should provide details in their submitted dossier.
“This description should allow a clear identification of the process versions used to produce each batch used in non-clinical and clinical studies, in order to establish an appropriate link between pre-change and post-change batches”, the EMA wrote.
Manufacturers can continue to make changes after approval of the trial but must alert the ethics committee if a ‘substantial’ change is planned. In its 2005 clinical trial guidelines the EMA said a change is substantial if it is likely to have a significant effect on the quality or safety of the drug.
The latest guidelines expand on this to give specific instances when notification is needed. Examples include a change of manufacturer, use of a different immediate packaging material, or a shelf-life extension that goes beyond the accepted stability protocol.