UK regulator plans crackdown on illegal medicines sold on social media
Key Points
- The MHRA will substantially increase criminal enforcement against illegal medicine sellers.
- The regulator will work with social media platforms and online marketplaces on harmful products.
- Yellow Card reporting of bad reactions will become simpler and quicker.
- A new Centre for AI and Digital Health will oversee AI medical tech.
- The plans form part of the MHRA’s 2030 Strategy, published on 14 October.
The UK’s medicines regulator plans a major crackdown on illegal medicines sold online. The Medicines and Healthcare products Regulatory Agency (MHRA) set out the plans in its 2030 Strategy, which it published on Wednesday (14 October).
The regulator said it would substantially increase its criminal enforcement capacity to investigate, disrupt and prosecute people dealing in illegal medicines and medical devices.
The MHRA will also work with social media platforms and online marketplaces to stop harmful products from reaching the public. It added that the partnerships would target health misinformation spreading on those platforms.
“This strategy will help the MHRA keep pace with the latest innovations in AI, data and medicine, while strengthening its ability to crack down on illegal medicines to keep the public safe,” said James Frith, Minister for Health Innovation.
The regulator plans to make its Yellow Card scheme simpler and quicker to use. Patients and healthcare professionals use the scheme to report bad reactions to medicines and medical devices.
The MHRA will recruit specialist staff and use AI to analyse real-world data from hospitals and genomics. The regulator said this would help it identify potential safety issues earlier.
It will also work with the Health Data Research Service on real-time surveillance to pick up safety signals sooner.
“AI is transforming both regulated products and how organisations are run,” said Lawrence Tallon, Chief Executive of the MHRA.
Faster approvals and AI oversight
The strategy includes several other commitments affecting patients and the companies that develop new treatments, including:
- A new MHRA Centre for AI and Digital Health to set clearer rules for AI-driven medical devices and medicines
- A modern regulatory framework for AI as a medical device
- A paid fast-track option cutting scientific advice for developers from 90 days to 45 days
- Halving the initial assessment target for qualifying Phase 1 clinical trials to 14 days
- Faster decisions on generic and biosimilar medicines to speed up patient access and NHS savings
- A Women’s Health Plan launching this year to improve health outcomes for women
- Continued recognition of CE-marked medical devices and closer collaboration with the US FDA
The MHRA will publish an AI Medicines Development Action Plan in 2027. The regulator said the plan would set out how it intends to use AI to transform medicines development.
