Regulatory Rapporteur - March 2025 | Regulatory Rapporteur

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Regulatory Rapporteur – March 2025

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March 2025 – Contents

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Data and AI: Readiness, research and real-world impact

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Organising high quality research and development data for success

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AI adoption readiness: Current status and trends in regulatory organisations

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Artificial intelligence and post-market surveillance

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Using data to drive regulatory performance

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Immunological considerations in the development of novel vaccines

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The EU’s Health Technology Assessment Regulation: Overview and considerations for regulatory teams

March 2025 – Contents
Data and AI: Readiness, research and real-world impact
Organising high quality research and development data for success
AI adoption readiness: Current status and trends in regulatory organisations
Artificial intelligence and post-market surveillance
Using data to drive regulatory performance
Immunological considerations in the development of novel vaccines
The EU’s Health Technology Assessment Regulation: Overview and considerations for regulatory teams

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Industry News

MHRA approves Nemolizumab for eczema patients in the UK
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Nemolizumab, also known as Nemluvio, to help with the treatment of atopic dermatitis (eczema) in the UK.
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.

More news

ICH releases M15 guideline on model-informed drug development

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M15 Expert Working Group has developed a draft guideline on model-informed drug development (MIDD) and is now under public consultation.

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.

CLICK HERE FOR ALL INDUSTRY NEWS

Podcasts

RegRapPod − InConversation with the UK ePI Task Force

2025-02-04T17:00:00+00:00By Claire McDermott, Andrew Burgess and Michael Clarke

InConversation talks electronic product information with Andrew Burgess and Michael Clarke

RegRapPod − In Conversation with Bengt Mattson

2024-05-31T00:05:00+01:00By Alan Booth and and Bengt Mattson

BONUS EPISODE: In Conversation talking sustainability with Bengt Mattson