News Archive

MHRA Consultation on proposals for legislative changes for clinical trials

17th January 2022

The MHRA are consulting on a set of proposals to improve and strengthen the UK clinical trials legislation to help make the UK the best place to research and develop safe and innovative medicines.

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REGISTRATION OPEN - EMA - Invitation to the webinar launch event for the Regulatory Science Research needs

12th January 2022

Invitation to the webinar launch event for the Regulatory Science Research needs on 18 January 2022

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EMA - EMA public consultation: ICH harmonised guideline on Quality Risk Management Q9 (R1)

22nd December 2021

The European Medicines Agency has published for public consultation on the ICH harmonised guideline on Quality Risk Management Q9 (R1).

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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021

21st December 2021

EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021

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MHRA - Business Impact Target

21st December 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) assesses its regulatory impact on businesses.

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MHRA - GPvP Inspection Metrics report for April 2020 to March 2021

21st December 2021

MHRA adds GPvP Inspection Metrics report for April 2020 to March 2021

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MHRA - MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions

21st December 2021

In October 2020, the MHRA launched a 6-week consultation with stakeholders on the MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions. Following the consultation and an analysis of the responses received, the MHRA has published two guidance documents.

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