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New European Medicines Agency fees: The effect on veterinary medicines

2025-06-06T14:07:00Z

In response to the EMA’s new fee system, this article dicusses the impact on marketing authorisation holders who place veterinary medicines on the market.

EMA to address antimicrobial resistance risks from veterinary medicinal products

2025-05-13T16:05:00Z

The European Medicines Agency (EMA) has published a new concept paper outlining plans to assess the risks of humans developing AMR from VMPs via the environment.

A key role for the European Medicines Agency in the European Union’s Health Technology Assessment Regulation

2024-06-18T09:05:00Z

Regulatory Rapporteur June 2024 | Volume 21 | No.6 Abstract The need for early collaboration between regulators and European Union’s (EU) Health Technology Assessment (HTA) bodies when developing ‘fit-for-purpose’ evidence generation plans has long been acknowledged, and the ...

EMA accepts new guidelines on investigational ATMPs

2025-02-17T12:54:00Z

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.

EMA establishes new standard procedure for high-risk medical devices

2025-02-17T13:20:00Z

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.

Rui Santos Ivo elected as new Chair of the EMA Management Board

2025-04-01T15:15:00Z

Rui Santos Ivo has been elected as the new Chair of the European Medicines Agency (EMA) Management Board. Mr Santos Ivo takes over from Lorraine Nolan, who completed her tenure on 21 March 2025.

Use of new EMA platform for monitoring medicine shortages to become mandatory

2024-12-13T11:17:00Z

The European Medicines Agency (EMA) has launched the European Shortages Monitoring Platform (ESMP), aimed at preventing and managing shortages of centrally authorised products (CAPs). 

​Veterinary Regulation 2019/6: Impact, challenges and the future: Interview with Ivo Claassen

2025-06-06T14:07:00Z

In this interview, Claire McDermott talks with Ivo Classen, Head of the Veterinary Medicines Division and Deputy Executive Director of the European Medicines Agency on the impact of Veterinary Regulation 2019/6. 

RegRapPod − InConversation with Ivo Claassen

InConversation talks veterinary regulation with Ivo Claassen, Head of the Veterinary Medicines Division at the EMA

Regulators publish new guidelines for use of AI

2024-10-23T14:27:00Z

The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) publish new guiding principles for the use of large language models (LLMs) in regulatory affairs.