Regulatory agencies on both sides of the Atlantic, the European Medicines Agency (EMA) and US Food and Drug Administration (FDA), are urging companies to apply to its joint good manufacturing practice (GMP) inspections because, since its launch in August 2009, the program has had a slow uptake. The regulators aim to increase the number of sites inspected and avoid duplication. But the advantages to companies may be elusive. “Biopharma and API [active pharmaceutical ingredients] manufacturers are undergoing audits and inspections, almost weekly, and this auditing burden is likely to increase under new proposals announced by the FDA in June,” says Hedley Rees, founder and CEO of Biotech PharmaFlow, a UK-based, supply-chain management company. To qualify for the joint inspection, companies must have submitted marketing authorization applications in parallel to both the EMA and the FDA, or be hosting a single joint routine reinspection. But these requirements are such that the advantages are lost on would-be applicants. “There are also ingrained cultural differences between the FDA and EMA inspections, with wide variations in requirements and interpretation,” adds Rees. “Companies perceive that having a joint inspection will simply raise twice as many issues, leading to negotiations with two parties and the production of two separate reports.”