February 2025 – Contents
Medical device regulation: Challenges, innovation and the future
The EU Medical Device Regulation: Balancing innovation with regulation
Implications of the EU’s AI Act for medical devices and in vitro diagnostic medical devices
An introduction to the Medical Device Single Audit Program
An industry perspective on the use of patient experience data in medicines development: Is further action needed from European regulators?
Regulatory strategy implications for foetal medicine
Immunological considerations in the development of novel vaccines
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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.
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.
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EC announces evaluation of medical device and IVD regulations
The European Commission (EC) has announced an evaluation of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
Use of new EMA platform for monitoring medicine shortages to become mandatory
The European Medicines Agency (EMA) has launched the European Shortages Monitoring Platform (ESMP), aimed at preventing and managing shortages of centrally authorised products (CAPs).
RegRapPod − InConversation with the UK ePI Task Force
InConversation talks electronic product information with Andrew Burgess and Michael Clarke
RegRapPod − In Conversation with Bengt Mattson
BONUS EPISODE: In Conversation talking sustainability with Bengt Mattson
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