Regulatory bodies

The European Medicines Agency has published new policies on handling conflicts of interests for its scientific committee members, experts and management board members.

The European Medicines Agency has published new policies on handling conflicts of interests for its scientific committee members, experts and management board members.

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb brings highlights from Deloitte’s 2025 Life Sciences Outlook Report with medtech leaders’ forecasting significant investments in AI/GenAI. Brian Bossetta talks about the US FDA’s newly formed Digital Health Advisory Committee. Elizabeth Orr highlights the pros and cons of penetration testing for cybersecurity and talks about the US FDA’s final guidance on pre-determined change control plans. Natasha Barrow highlights UK MHRA's AI Airlock Pilot program and MANIFEST.

New guidance on data transparency from European medicines regulators will mean more administrative burden for small and medium sized companies.

The Therapeutic Goods Administration says it wants to balance regulatory burden on sponsors with the need to improve its monitoring of medicine shortages.

As talks continue on the EU pharmaceutical legislative reform proposals, drug firms may have to wait some time before they find out what the future periods of regulatory data protection and orphan market exclusivity will be.

Meeting the regulatory gold standard for drug candidates in ultra-rare diseases can be impractical, a regulatory expert says, but greater collaboration and shared insights from regulatory reviews could help find a viable path forward.