Drug regulators around the world face up to challenge of AI

Drug regulators have urged the exploration of regulatory practices targeting artificial intelligence-powered and other innovative medical devices, as well as the promotion of international cooperation in drug regulation to advance global health.

Xu Jinghe, deputy commissioner of the National Medical Products Administration, told an international event in Shanghai last week that technological advances in recent years had spurred the development of medical devices replying on innovative tools such as artificial intelligence, biomaterials and 3D printing.

Regulatory authorities across the world are expected to experiment with new tools and methods, rather than sticking to conventional frameworks, to ensure the safety and efficacy of innovative medical devices while guiding further development of the industry, he said.

Xu made the comments during the 27th annual meeting of the Global Harmonization Working Party, an international organization comprising regulatory authorities and industry representatives that is committed to stepping up the harmonization of medical device regulatory requirements. Xu was elected the organization's chairman in February.

Over 600 participants from 25 countries and regions attended the meeting from Nov 27 to Thursday.

Tran Quan, the head of the working party's capacity building team, said new technologies are playing a role in a wide range of medical fields, such as using robots to carry out minimally invasive surgeries, tapping the potential of artificial intelligence in analyzing images and diagnosis, as well as using 3D printing to produce orthopedic and dental implants.

"As drug regulators, we are obliged to get ahold of these latest developments, make rapid and agile responses and deal with them in an innovative manner," she said, adding that it is important to strike a balance between guaranteeing the safety and efficacy of medical devices and fueling innovation.

"It is also important to promote international cooperation, share good practices and try our best to prevent repetitive work," she said.

Jia Jianxiong, an official with the administration's Center for Medical Device Evaluation, said China released an accelerated market application channel for innovative medical devices in 2014 and updated the protocol in 2018.

As of October, he said the center had received about 2,450 applications and 234 products had been granted market approval through the channel.

Yang Pengfei, another official at the center, said China's top drug regulator has published or is reviewing 21 guidelines concerning digital health, 12 of which are related to AI-powered medical devices and are aimed at providing guidance for the industry when applying for market registration in China.

He said that from January 2020 to May of this year, the administration had approved 56 Class 3 deep learning-assisted medical software applications that can carry out medical functions without any actual hardware. The number of such applications approved in 2022 was 2.6 times that in 2020.

Twenty-five are expected to gain market approval this year, he added.

Administration Commissioner Li Li said it will continue to facilitate the development and market registration of innovative medical devices.

He said the administration will deeply engage in working party activities, enhance global communication and cooperation in drug regulation and make greater contributions to building a global community of health for all.

Xu said the working party now covered more than 50 percent of global population. The organization has formulated and launched 48 technical guidelines as part of efforts to step up the harmonization of medical device regulation around the globe.

More efforts aimed at developing regular guidelines and creating mechanisms to facilitate close cooperation are underway, he added.