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Joint regulatory API inspections on the rise.
What do regulators talk about behind closed doors? Just about everything! The good news, however, is that one area getting a lot of attention behind the closed doors of the European Medicines Agency (EMA) and the FDA is regulatory harmonisation. At the 2010 symposium of The Organisation for Professionals in Regulatory Affairs (TOPRA), held in London (UK) in October, regulatory international cooperation and communication emerged as a key theme.
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Hilde Boon, the EMA's liason official at the FDA, described a number of ways in which the EMA and FDA are collaborating. "Many of our exchanges concern changing draft review reports and assessment reports," she explained. "We also share pharmacovigilance information and we have ongoing pilots in GMP/GCP that allow us to exchange inspections information and start planning for possible joint inspections."
One of the most interesting developments is the growing number of joint API inspections via a pilot programme being conducted by the EMA, the FDA and Australia's Therapeutic Goods Administration (TGA). The benefits? Less duplicate routine inspections — a benefit to both manufacturers and the workloads of regulators — and an increase in the overall number of API manufacturing sites inspected.
"We've heard from sponsors and manufacturers of APIs that they sometimes suffer from inspection fatigue," explained Janice M. Soreth, Deputy Director of the FDA's Europe office and liason to the EMA. "One way to alleviate this is for us to partner and do inspections together."
As of Q1 2010, seven joint inspections have been conducted; one involving the EMA and the FDA, five involving the EMA and the TGA, and one involving the FDA and the TGA. Several other joint inspections are also currently in the process of being concluded.
"In addition to joint inspections or observing one another in inspections, there are also frequent requests from one or the other authority for reports of API inspections that we think may have been conducted by one of our partners," said Soreth.
Perfect harmonisation impossible?
Unfortunately, perfect harmonisation between the agencies is still a long way off and the issue of duplicate inspections still hasn't been nailed. Soreth admits that the reasons for these duplicate inspections still needs to undergo further analysis and that they may stem from lack of communication. In some instances, however, it may be that it was an inspection for cause rather than a simple routine inspection.
"No matter what level of confidence we may have in one another, our laws and our need to defend any enforcement actions we take will probably always leave us in a position, at least for inspections for cause, where we have to do our own inspections," said Soreth.
Another area that the EMA and FDA are working closer together on is GCP. In September 2009, another pilot was initiated whereby the agencies will exchange GCP-related information and conduct collaborative GCP inspections, in light of the fact that more and more data from foreign facilities and clinical trial sites are making up applications to the EMA and FDA.
"This can sometimes present an opportunity for less attention to detail and, in the worst cases, economically motivated deviations from GMP and GCP," said Soreth. "With our GCP pilot, we get our arms around the global conduct of clinical trials to assure ourselves that they're ethically conducted and to assure the integrity of the data that makes up a marketing authorisation application."
There will always be differences between the agencies; however, where possible, efforts to harmonisation are being made. "Whether we're talking about the pilots or our other collaborations, these exchanges drive us to harmonisation where that's possible," said Soreth. "At the same time, it also helps us to identify areas where we diverge or where we look at the same body of data and take a different decision."
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