News Archive

EMA - Human Medicines Highlights 2022

21st February 2023

EMA releases highlights from 2022.

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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)

15th February 2023

6 - 9 February 2023

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EMA - A new role for EMA in monitoring and mitigating critical medical device shortages during public health emergencies

15th February 2023

As of 2 February 2023, EMA’s additional responsibilities regarding the monitoring and mitigation of shortages of critical medical devices during public health emergencies will apply. The new provisions are the last remaining part to be implemented of Regulation (EU) 2022/123, that reinforces EMA’s role in crisis management of critical medicinal products and medical devices during public health emergencies.

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EMA - Actions to support the development of medicines for children

15th February 2023

Regulators in the European Union (EU) have taken several initiatives in the past four years to increase the efficiency of paediatric regulatory processes and boost the development of medicines for children.

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EMA - CTIS newsflash – 10 February 2023

15th February 2023

Now Released

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EMA - Human Medicines Highlights Issue 166

15th February 2023

Now Released

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EMA - Public consultation on a multi-stakeholder platform to improve clinical trials in the EU

15th February 2023

On 3 February 2023, EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) are launching a public consultation on the establishment of a multi-stakeholder platform to improve clinical trials in the European Union (EU). EMA - Public consultation on a multi-stakeholder platform to improve clinical trials in the EU

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MHRA - List of Accredited Phase I Units (Last Updated 01 February 2023)

15th February 2023

List of Accredited Phase I Units updated 1 February 2023.

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MHRA - Manufacture of Investigational Medicinal Products – Frequently Asked Questions

15th February 2023

A review and update of the 2016 blog.

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MHRA - UK to introduce first-of-its-kind framework to make it easier to manufacture innovative medicines at the point of care

15th February 2023

The establishment of a regulatory framework for POC manufacturing would bring a range of benefits to patients, healthcare professionals and innovators.

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