News Archive

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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MHRA - new recognition routes

31st May 2023

MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners

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MHRA - changes to the ICH E6 GCP Guideline

29th May 2023

Andrew Fisher, Lead Senior GCP Inspector, writes a blog about the recent changes.

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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 May 2023

25th May 2023

CVMP opinions on veterinary medicinal products

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FDA - Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products Guidance for Industry

25th May 2023

This guidance describes FDA’s current recommendations regarding adjusting for covariates in the statistical analysis of randomized clinical trials in drug2 development programs. This guidance provides recommendations for the use of covariates in the analysis of randomized, parallel group clinical trials that are applicable to both superiority trials and noninferiority trials.

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FDA - Discussion Paper: Artificial Intelligence in Drug Manufacturing

25th May 2023

As FDA considers the application of its risk-based regulatory framework to the use of AI technologies in drug manufacturing, the Agency has identified in this discussion paper areas for which public feedback would be valuable.

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FDA - Guidance Snapshots/Podcasts highlight the agency’s commitment to improve the diversity of participants in clinical trials

25th May 2023

The FDA have published two Guidance Snapshots accompanied by two Guidance Recap Podcasts to highlight the agency’s commitment to improve the diversity of participants in clinical trials, and to increase awareness of the agency’s 2020 guidance, Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs, which presents recommendations sponsors can apply to diversify participation in clinical trials.

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WHO - WHO issues urgent call for global climate action to create resilient and sustainable health systems

25th May 2023

Today (24th May) at the World Health Organization (WHO), panelists made an impassioned plea for urgent climate action as it hosted a Strategic Roundtable on the Role of the Health Communities in Climate Action: taking stock and moving forward at the World Health Assembly.

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ICH - ICH E6(R3) Principles, Annex 1 and Annex 2

23rd May 2023

ICH-E6(R3): An Important Global Good Clinical Practice Standards - Available for Public Input.

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