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EMA establishes new standard procedure for high-risk medical devices
The European Medicines Agency (EMA) has established a standard procedure for manufacturers of high-risk Class III and Class IIb medical devices to request scientific advice.
Industry news
EMA accepts new guidelines on investigational ATMPs
The European Medicines Agency (EMA) has adopted the Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials, which officially comes into effect on 1 July 2025.
Pharmacies told to follow GPhC guidance on prescription-only weight-loss medicine
Online pharmacies in England, Scotland and Wales are required to follow updated guidance from the General Pharmaceutical Council (GPhC), after concerns that prescription-only medicines (POM) for weight loss are being inappropriately supplied.
MHRA issues guidance on post-market surveillance regulation in Great Britain
The Medicines and Healthcare products Regulatory Agency (MHRA) has published The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on implementation
FDA releases new draft guidance on assessing artificial intelligence data
The US Food and Drug Administration (FDA) has released new draft guidance which provides a risk-based credibility framework that can be used for assessing artificial intelligence (AI) data in the drug product lifecycle.
More news
Use of new EMA platform for monitoring medicine shortages to become mandatory
Increased debate over lecanemab
GSK Blenrep trial shows ‘significant overall survival benefit’of myeloma treatment
Greater post-market surveillance for medical devices
FDA proposes to remove oral phenylephrine in selected drugs
New cancer drug approved by MHRA
New guidance for wholesalers and manufacturers following Windsor Framework
