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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.

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.

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.

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 ...

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). 

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.

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

2025-03-07T11:29:00Z

The EU’s Health Technology Assessment Regulation (EU-HTAR) demonstrates a significant transformation in how health technologies are evaluated across EU member states (MS). The regulation, which came into effect on 12 January 2025, establishes a partnership between the European Medicines Agency (EMA) and national Health Technology Assessment (HTA) bodies through introducing joint clinical assessments (JCAs) and joint scientific consultations (JSCs).

Contraindication for mixing weight loss medicine Mysimba with opioids

2024-09-16T09:18:00Z

The European Medicines Agency (EMA) published new advice in July 2024 concerning the combined use of opioid medications and the weight loss drug Mysimba (naltrexone/bupropion).

NICE and EMA say new Alzheimer’s drug is ‘not recommended’

2024-09-16T09:13:00Z

 The new draft guidance from NICE states that Lecanemab is ‘not recommended’ and the EMA has recommended the refusal of the marketing authorisation for Leqembi.