News Archive

MHRA - MHRA issues new guidance on the use of life saving adrenaline auto-injectors

19th June 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during anaphylaxis. This new guidance includes an easy step-by-step guide on what to do in an emergency and provides updated advice on body positioning.

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EDQM - 2022 Highlights – EDQM annual report now available

14th June 2023

2022 Annual Report available to view

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EDQM - Ph. Eur. Commission keeps pace with veterinary vaccine development efforts

14th June 2023

Vaccines for veterinary use (0062), Evaluation of safety of veterinary vaccines and immunosera (5.2.6) and Evaluation of efficacy of veterinary vaccines and immunosera (5.2.7).

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EMA - CTIS Newsflash, June 2023

14th June 2023

CTIS newsflash – 9 June 2023

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EMA - Draft ICH E6 (R3) guideline on good clinical practice – step 2b

14th June 2023

The European Medicines Agency has published for public consultation a “Draft ICH E6 (R3) guideline on good clinical practice – step 2b”.

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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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