Regulatory


A harmony of “I 8


’ve been working on this for a long time,” says Mic McGoldrick, associate director global CMC policy at Merck, where he has been for more than 30 years. “It goes nowhere for a while, then it’s sort of like an earthquake: the pressure builds up and then it slips.” He’s talking about regulatory harmonisation and the global


interests


Data sets obtained through collaboration across multiple countries are an important way to strengthen research findings, and in some cases can be necessary to study rare diseases due to the limited number of cases. But there’s no overarching governance on conducting trials, and in many cases, organisers must navigate a complex web of regulation that spans both countries and regions within them before research can begin. Mae Losasso speaks to Mic McGoldrick, associate director, global chemistry, manufacturing and controls (CMC) policy at Merck, and Akira Yamaguchi, chief technology officer (CTO) at LORENZ Life Sciences Group, to better understand global clinical trials regulation and what’s being done to achieve greater harmonisation of the rules.


streamlining of clinical trial applications, which, as it stands, faces an arduous but urgent uphill struggle. “I would be surprised if we got a lot more harmonisation in the next five years,” McGoldrick says. “Maybe in ten years. Then you may see a much more reasonable push to get more harmonisation globally.”


Clinical Trials Insight / www.worldpharmaceuticals.net


RORONOR; bearsky23; 23WaysArt/Shutterstock.com


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