News Archive

MHRA Board Meetings in 2023

21st December 2022

MHRA Board Meetings in 2023

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MHRA to receive nearly £1m BEIS funding to unlock digital, data and scientific regulatory innovation

21st December 2022

MHRA to receive nearly £1m BEIS funding to unlock digital, data and scientific regulatory innovation

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TransCelerate - Considerations for Data Relevance and Reliability

21st December 2022

Does your organisation provide or utilise Real-World Evidence / Real-World Data for regulatory-grade research? TransCelerate Biopharma Inc.’s Real-World Data (RWD) Audit Readiness Initiative wants to hear from you!

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EMA - public consultation - Reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variations.

15th December 2022

This draft reflection paper provides potential criteria to support the demonstration of a reduction in the antimicrobial or antiparasitic resistance, or an improvement of the benefit-risk balance. Comments should be provided using this template and sent to vet-guidelines@ema.europa.eu by 28 February 2023.

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MHRA Blog - When is a clinical trial halt not a clinical trial halt?

15th December 2022

As the regulator, the safety of those volunteering to participate in clinical trials is our first priority, and our oversight of trial conduct is informed by trial sponsors efficiently notifying us of safety issues during the conduct of their trial. This blog aims to clarify regulatory expectations for notification of temporary halts via a substantial amendment and requests to restart a trial after a temporary halt has been notified.

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EDQM - Contribute to shaping the future EDQM strategy – Stakeholder survey

30th November 2022

EDQM - Contribute to shaping the future EDQM strategy – Stakeholder survey

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EMA - New Quality Innovation Expert Group (QIG) supports medicine innovation

30th November 2022

EMA has established a Quality Innovation Expert Group (QIG) to support innovative approaches for the development, manufacture, and quality control of medicines for the benefit of patients in the European Union (EU). These include, but are not limited to, new technologies, digitalisation, novel materials and novel devices, in line with the priorities highlighted in EMA’s Regulatory Science Strategy to 2025.

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