Regulatory
Regulatory rules for filing clinical trial submissions differ between countries and the regions within them.
to create these dossiers electronically,” Yamaguchi says. “Our main customer is industry, but we’ve also managed to get the same software through to the agencies. Just to name [a few]: the FTA in Canada; some European agencies; China’s agency – they’re all our customers.” The technology looks promising, but it’s no magic bullet and, as McGoldrick points out, there are still “all the countries that fall in between. Different agencies have different levels of capabilities and technical savvy,” McGoldrick says. “And there are still a good 70 countries that can give problems in trying to get a single dossier out there.” Even among the countries that do have technical savvy, overcoming region-specific requirements remains a serious task, above and beyond the capabilities of high-tech electronic documentation. As McGoldrick points out, even the three founding members of ICH – the USA (FDA), Japan, and Europe (EMA) – are still not yet fully harmonised.
“You’re going to get groups that will pull certain countries together to harmonise and slowly they’ll bring other ones together. Even if you got regional harmonisation that would make things a lot easier.”
Mic McGoldrick
But the Covid-19 pandemic, and the development of a vaccine in record timing, may have edged along the mindset shift that’s needed to push something like global regulatory harmonisation to the next level. One of the key lessons learnt, McGoldrick says, has to do with reliance. During the development of the vaccine, “WHO did a review of the dossier based on a review done at the same time by the EMA. And once they gave approval, the 110 countries they worked with
10
approved it within 10–15 days, which means they really didn’t do a lot of reviewing. They had to rely on WHO and EMA having done the work for them”.
The future of regulation
In addition, “they allowed for a lot of the information be given post-approval so you didn’t have to have validation completed on your product before it was allowed to get out there to people – but there was a commitment to provide the validation data later”. Will we see more reliance on health organisations, and more post-approval procedures in the development of day-to-day products, or will this kind of approach be reserved only for pandemics and cases of high medical need? That remains to be seen, but the fact that it was achieved looks promising for the future of regulatory harmonisation in the clinical trial setting. So what does the future of regulatory harmonisation look like? “I think it’s heading more in the direction of cloud shared processing,” Yamaguchi says, “where shared means between industry, the submitting organisation, and the regulators. We have to think about some national specialities, but in the end, we’re all humans and [pharmaceutical companies] will be selling their drug worldwide, so this kind of global approach requires the sharing of agency information. We believe technology is only a fraction of it; the main challenge is still regulation within the legal piece.” For all McGoldrick’s scepticism about the rate of change, he remains optimistic about the future of regulatory harmonisation. “I think it’s going to continue to move forward. You’re going to get groups that will pull certain countries together to harmonise and slowly they’ll bring other ones together. Even if you got regional harmonisation that would make things a lot easier. I think people want to work towards it. I know industry wants to work towards it. But how fast it will move is a mystery.” ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
Fly Of Swallow Studio/
Shutterstock.com
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