News Archive

FDA - FDA Roundup published, June 2023

14th June 2023

13th June 13 2023

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ICH - The ICH E6(R3) draft Guideline presentation available now on the ICH website

14th June 2023

ICH E6(R3) Presentation now available

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PIC/S - Bulgaria / BDA and Saudi Arabia / SFDA join

14th June 2023

Bulgaria / BDA will become PIC/S’ 55th Participating Authority and Saudi Arabia / SFDA PIC/S 56th Participating Authority as from 1 July 2023.

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PIC/S - Changes to the PIC/S Executive Bureau

14th June 2023

A new PIC/S Deputy Chairperson and a new PIC/S Sub-Committee on Strategic Development (SCSD) Chair took office on 11 May 2023.

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CIOMS - Real-world data and real-world evidence in regulatory decision making

12th June 2023

You are invited to comment on the below report.

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MHRA - Windsor Framework medicines announcement

11th June 2023

The Windsor Framework sets out a long-term solution for the supply of medicines into Northern Ireland. These measures will commence on 1 January 2025.

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EMA - Progress with EU-US mutual recognition agreement for inspections for veterinary medicines

7th June 2023

On 31 May 2023, the European Union and the United States have made important progress towards enabling mutual recognition of inspections of manufacturing facilities of certain veterinary products.

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EMA - Veterinary Medicines Highlights Newsletter

7th June 2023

News, activities and interviews from the Veterinary Medicines Division. Published quarterly by the European Medicines Agency.

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EMA - CTIS Newsflash -26 May 23

31st May 2023

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

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MHRA - New regulatory pathway set to support safe patient access to innovative medical technologies

31st May 2023

Set for launch later in 2023, the Innovative Devices Access Pathway (IDAP) will be run by the MHRA, NICE, and other partners, including the devolved administrations.

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