Pharmaceutical manufacturing

Manufacturing is part of what regulators approve, not a step that follows approval. Quality, consistency and supply chain are assessed alongside efficacy and safety, and for biological products the process substantially defines the product itself — which is why exact copies are not possible and biosimilars follow their own regulatory route.

Our coverage includes manufacturing because it is a common and under-reported cause of shortages, recalls and delayed launches. A medicine that cannot be made reliably is not available, whatever its licence says.