Tag: pharmaceutical regulation
UK Regulator Streamlines Drug Label Changes Via Self-Certification Model
The UK MHRA has published guidance permitting pharmaceutical manufacturers to submit non-safety-critical changes to drug labels and Patient Information Leaflets…
UK Regulators Issue Warning on Unlicensed Weight-Loss Drugs and False Marketing Claims
UK regulators have issued a joint warning against businesses promoting unlicensed weight-loss medicines and newly authorised prescription drugs with false…
South Africa’s drug regulator strengthens industry partnerships to improve medicine access
SAHPRA implements quarterly stakeholder engagement sessions with pharmaceutical industry leaders to streamline regulatory processes and improve patient access to essential…
Trump Administration Proposes Rule to Close Medicare Drug Price Negotiation Loophole
Trump administration proposes rule to close Medicare drug price negotiation loophole, potentially affecting 65 million beneficiaries. Policy targets pharmaceutical industry…
MHRA Reports Progress on Health Equity Through Regulatory Reform
The UK's MHRA has published its 2025-2026 Public Sector Equality Duty report, demonstrating systematic progress in embedding equality principles across…
Biotech Industry Faces Strategic Inflection Point Amid Cost Pressures and Innovation Demands
Veteran biotech executive Jeremy Levin discusses how the industry faces a critical juncture with $2.6 billion average drug development costs…
UK Medicine Broker Registry Updated to Strengthen Drug Supply Chain Oversight
UK MHRA has updated its public register of authorised medicine brokers, strengthening oversight of pharmaceutical intermediaries. The registry provides transparency…
MHRA Grants Marketing Authorisations to 47 New Medicines in 2026
MHRA granted marketing authorisations to 47 new pharmaceutical products in 2026. The approvals reflect continued pharmaceutical innovation and UK regulatory…