News Archive

MHRA - The Innovative Devices Access Pathway (IDAP) Guidance

20th September 2023

Launched 19th September 2023

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MHRA - UK patients set to have faster access to innovative medical technologies via new pathway

20th September 2023

The Innovative Devices Access Pathway (IDAP) pilot was launched on 19th September 2023.

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MHRA - performance data for assessment of clinical trials and established medicines

20th September 2023

Published 15th September 2023

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MHRA - Yellow Card centre launched in Northern Ireland to strengthen patient safety

13th September 2023

A new regional centre to promote Yellow Card reporting has been launched in Belfast on 13th September 2023.

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EMA - 3rd Veterinary Big Data Stakeholder Forum

8th September 2023

Being held on 23rd November 2023

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EMA - Survey on the Implementation of the CTR 536/2014

7th September 2023

EMA are now launching a second EU survey aimed at collecting further views of sponsors and stakeholders on this updated regulatory and IT environment, identifying the remaining blocking issues, in order to plan and monitor their resolution.

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EMA - Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 August 2023

6th September 2023

Meeting highlights

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EMA - CTIS newsflash, 1st Sept 2023

6th September 2023

This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.

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EMA - Human Medicines Highlights Issue 172

6th September 2023

August 2023

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FDA - Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products

6th September 2023

New guidance for industry

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