News Archive

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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FDA Informed Consent - Guidance for IRBs, Clinical Investigators, and Sponsors

6th September 2023

Released August 2023

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FDA Roundup: 1st September 2023

6th September 2023

An at-a-glance summary of news from around the agency,

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MHRA - Three new UK Approved Bodies to certify medical devices announced by the MHRA

6th September 2023

TÜV SÜD, Intertek, and TÜV Rheinland UK join the four current UK Approved Bodies, almost doubling current capacity for the certification of medical devices in the UK.

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PIC/S - Entry into force of revised GMP Annex 1

6th September 2023

The revised Annex 1 on “sterile manufacturing of the PIC/S GMP Guide entered into force on 25 August 2023 and has been published.

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