EMA lags behind FDA on continuous manufacturing regulation

pharmafile | June 15, 2017 | News story | Manufacturing and Production |  EMA, FDA, continuous manufacturing 

Continuous manufacturing is increasingly an area of fixation within the pharma industry for the benefits it can bring to the table over the traditional batch method employed by many firms. While adequate regulation of this method is needed for effective and widespread adoption, there appears to be a discrepancy between approach on both sides of the Atlantic.  

For academics, EU health ministry representatives and industry groups meeting at the Oral Solid Dosage (OSD) Continuous Manufacturing in the Current Regulatory Landscape summit in Malta, regulation of continuous manufacturing solutions was the order of the day. Douglas Hausner, of the Rutgers University-based Centre for Structured Organic Particulate Systems, was quoted explaining the divide in stances taken by the FDA and EMA, with the former taking the lead on offering support to facilitate the adoption of the technology.  

“Currently, the FDA is strongly advocating for the adoption of the technology,” he remarked. “They have created specific offices to facilitate this technology, funded work at universities, re-aligned internally, and hired a significant number of engineers all within the last two to three years. In my opinion, they really could not be encouraging this more than they already are.”

By contrast, regulators in the EU are lagging behind with regards to offering guidance to would-be adopters, despite a clear desire in the industry to embrace the technology.

“People are very eager for regulatory clarity and guidance on this topic, but the regulators are not yet ready to put that out there,” he continued. “EMA isn’t set up like the FDA, it doesn’t have the same centralised lab facilities, funding or direct personnel. As a result, EMA is looking to learn from applications.”

Elsewhere, at the International Institute for Advanced Pharmaceutical Manufacturing, it was agreed that regulatory flexibility will be key to adoption of continuous manufacturing, with Christine Moore, Merck’s Executive Director of Chemistry, Manufacturing and Control, stating, “The biggest challenge we have is alignments” – an issue which she argues is slowing uptake of the technology.     

Matt Fellows